Confirmation Number:370870
Event Started: 6/15/2005
Have done over the life of this committee, having been -- much more work having to do with today and tomorrow. The meeting would make well as announcements on the SACGHS website. Today is going to Indiscernible ] Three of our key members are leaving us and their official commit -- capacity ofas members. Hopefully we will have access to their input informally and formally on a regular basis. Our colleagues Indiscernible ] For all that they have done and had ab opportunity to make -- an opportunity to make -- watch out.
We want to avoid that. We're appreciative for everything they have done. We're also happy to -- today that there are new members joining us. Let's welcome Indiscernible ] Joining us from the department of health where she has been the last four years. Indiscernible ] Second,. And she is going to -- a large suburban national laboratory. The representatives of the San Francisco advocacy for a volunteer group and patients group with breast cancer research. -- Indiscernible ] From the university of North Carolina. The department of genetics and the director of the cancer Indiscernible ] And finally, Dr. Indiscernible ] Joins us from California, Los Angeles, where he is an associate program director of the ucla Indiscernible ] Research director and the Euro psychiatric -- he's the network financier research network nationwide research response order by NIDMS and other NIH components, to Sylvia, tiara, Jim and h -- julio, please pre--- feel free -- you're not expected to knock our socks off the first half hour of the meeting. Don't know anxious if you're wondering how can -- did it get on this committee and what ary that expecting from me. How they got to where they are today, the history of all of this. That's wen fine. Wan Cory, it took him and I don't think he understands any of this.
He was on the last committee, to. That's fine. The one -- one thing that Ed taught me many things, he's that time this committee and the predecessor that what is important for us is to develop a relationship between all of us because we have to depend on each other for judging guidance inside the meeting and outside of the meeting. Take your time and relax on what this could be an enjoyable meeting and thank you all for joinings -- joining the committee. Our new members, by the weigh, will partic58 as ad hoc members whole the processing of the members is completed. Their complete biosketches can be found in the folders, but you're still her on. What does that mean? All right. Good. Indiscernible ] Joan will be joining us tomorrow, Chris Hook and John are inable had -- able to denned attend this edition of the meeting. We have new faces, Dr. Barry Straub, the ex officio from CMS.
Ellen barry joins us from the representative of commerce. Julian gory presents us from the office human resource protection, and let me now acknowledge is the outside activities of two of our members, join Reid, represented SACGHS at the NH/NCH here in Bethesda in January and covered the training and we thank Joan for that extra effort and Cindy Barry represented the insurance plan commit -- committee last week and covered our work on coverage and the re-- reimbursement on genetic discrimination. Cindy, thank you for your important work there. We have a bit of housekeeping I need to go through formally. Last, at the end of the last meeting, Dr. Joe Boone and Steven Indiscernible ] Gave us a presentation. Unfortunately, there was not a choirom by the -- qo -- quorom by the time their presenting are given. As much, I need us here to review by a couple of views of points made. At the end of the meeting, we heard about ongoing efforts to improve access to quality care. Here's what they had to say. Whole individually Indiscernible ] Rare diseases and conditions, collectively affect a significant portion of our population. The majority of the six to 7,000 known rare diseases are considered genetic, making it, the testing essential to the diagnosis of the condition. How far, the development of the test for rare genetic diseases has not kept pace with the plogress of our knowledge -- progress of the our knowledge of the genetic bases of our disease -- diseases. Were told about the conferences being pland in September of 2005 in D.C., the goals of the conditions are to raise national array -- awareness the growing public meeting to improve the availability, equality and acceptability of genetic testing for rare diseases and promote development of multiple process ease and models to an end of the translation of the recoach -- research and Cripical practice. The announcement multiple goals are for outcomes for individuals and families to access tests, ease of access and third-party depine de10ment, usefulness of test results, adequate followup systems and education and support of testing after it's a completed. The conference in September will build on a acceptness of an earlier meeting held in may of 2004, called promoing testing of rare diseases key to ensuring quality subject to rare diseases of the at that poet -- meeting, recommendations were were developed by many to address this important aspect in healthcare W. that as a summary, are there any questions for further discussions on that bit of past history before we provide to pre-- review this meeting's agent -- a jpd A. having read that into record of what happened is a very important presentation. This is what we intend to accomplish today and tomorrow. I want you to -- if you recall and as you see on the following slide on -- I keep going back to the slide of our list of the 12 issues that when we first organized ourselves with the committee on, we identified and priority eased as devoting priority eased as devoting the attention in -- for knows where we are now and the process and this is especially useful not only for the new members but for all of us. Are we offensive to your behavior. Welcome aboard. We have introduced you and how terrific and wonder 68 you are. The -- wonderful you are. The first questions are going right to you. No,.
The into yourself; this, again s our road map. As your mare -- chairman, I want to make sure that we're all aware of where we are on the road map and whether we're meeting our targets and deadlones. Let's make it -- to read, feel free to up and look at it more carefully. What that take -- basically says is in keeping with our can you rent plan, we'll be considered in-depth in this meeting, two of our high-priority issue. Coverage of the acceptance services and form of genomics. We will hear updates on three other up--tonics important to us: Discremeination, direct consumer marketing of direct test observances and large population studies. You will recall the committee deferred considerations of the patent -- use this one?
May be. I was working awfully hard. Thank god. Catch my breath, I can -- in keeping with our, so where we are, we that remember we deferred consideration of the patents and access until the national academies committee on intellectual property rights in genomic and protein-related interventions issues its report. That report is expected to become completed later this summer. The committee will receive that report as possible and then we willp vote a representative from the NAS committee to update us on the findings and recommendations at our October meeting. This issue is being dealt with safely in the process, and we need to do nothing further until October. We will start this meeting, our 7th w an update on the genetic discrimination package transmitd to the secretary and a briefing on the status of pending legislation in congress, related materials can be found in Tab 3 of your briefing books. Following the genetic cis discrimination update this morning, we'll be briefed about the secretary's response to the committee's let or director consumer marketing of genetic tests and services relevant to agency opportunities and f -- FDA AS --s role in the overseat of genetic tests found in Tab 5. We'll consider next steps taken with regard the issues of large population study. That's going be a very, very important and interesting conversation. It's unfortunateom a half hour, so one eng I want to make one thing I want to make sure is if any of you have something you may have to do, step out or something, don't mess that half because on miss that half hour. It's a key one. We're going to need you focussed on that. have to be specific about guidance and we have a load a lot of time to give that guidance to the task force. I -- highlight this as an important part of the meeting. We will spend this afternoon completing our work on coverage and reimbursement which we have spent a substantial amount of time over the past year. We will consider the numerous public comments received and we will finalize the report and recommendation. We will finalize the report and recommendation. We will finalize. Because Cindy Barry will lead us through that. Let me tell you on this one. We're going to be focused in our conversation. We're going to listen consider -- very carefully to each other. We practice this a lot last tight -- time. We're really good at listening to each other and not going off the roar, off into the wild blue yonder painting outside of the lines with all sorts of intellectual discourse. We're going to stay in the lines and run this thing through and get through a consensus. I'm about this one. Tomorrow, em we will focus on another one of our high-priority issues, pharmacogenomics. Thepharmaco jep onlyics task force with excellent -- from SACGHS task, has put an outstanding job of putting's session tomorrow giving us a solid foundation work -- moving forward with the work on the topic. Our goal will be how to determine how to provide the development of report and recommendation to the secretary on this public. Football public commentsar are scheduled for both days. One of the things our new members will fine find, this is a relentlessly open process and we benefit from significant input always from the public, and we're always plaid to be able to take time -- glad be able to take time to do that. At 1:00 after lunch, we'll hear from the public. Individuals who would like to provide testimony and have not already signed up should do so at the registration take -- desk. A final reminder, members and exo fishios who would who want to lunch, do so no later than 9:00 a.m. at the registration disk or else. Finally issue as I turn to Sarah for a few reminders about the rules of governing us as special government employees, let me say one thing, Sarah. You and your team are performing speck tool spectacularly. The amount of effort that goes into staffing this committee is extraordinary and the number of late-night phone calls, where people can't get home and the number of hours that we're pulling staff and teen team is just extraordinary. I want the committee to be well aware and hopefully who Jeff your boss is who is lessen -- whoever your boss is who is listening, I will make sure they find out. That is this is an extraordinary staff and we're well-served by you and all of them.
very much for that and I can't take any credit. I don't do any of the worked, actually. A mand accusan and f -- Faye do it all. We valuesa -- have a summer intern, abby is here with us. We're putting her to work as well. very much, Reed. I'm going to remind the committee about the conflicts of interest rules that you all have to follow. Because you're appointed as special government employees. And even though you're special, you, you're o bleejd to follow the rule -- oblige -- obleged to follow the rules of conduct. They're outline today in the document, the standards ofco -- conduct employees. You received one of these books. I will highlight three of the rules today. The first one is conflicts of interest. Before every meeting, you provide us with information about your personal, professional and financial interests and information we use to determine whether you have any real potential or apparent conflicts of interest that could compromise your ability to be objective in giving advice during committee meetings. While we wave comflicks of interest for general matters, because we believe your ability to be objective will not be afternoon -- affected by your interest in some -- in such matters, we rely to a great degree to be attentive during our meetings to a possibility that an issue could a rise that could a -- affect or appear to affect your interest in a specific way. We have provided you with a list of your financial interests and relationships that could pose a conflict to you if you're a -- they're a focal point in our deliberations. If this happens, we ask you to recuse yourself. The other rule is the emolients clause. It prohibits you from being employed by or accepting e mole -- emolients from a federal government including from foreign universities that are government-operated. An e mole ument includes salary, honoraria, transportation and per dieem. The prescription on accepting gifts extends to your spouse independence and yet also applies at all times during your appointment, not just during our meetings, these restrictions are constitutional and are not matters of policy that can be waved or reconsidered. The last rule I want to talk about is lobbying. Government employees are prohibitd from lobbying and us this, we May not lobe as individualors a committee. If you lobby in your professional come -- capacity or as a private citizen, it's important that you keep activity, this activity separate from the activities associated with our committee. in mind that we advise the secretary of health and human services. Not the congress. And I want to thank you for being so attentive to the rules. It's very important that we do so, and I appreciate it.
Great. Thank you. By the way, in that emolument part, was that about travel?
Yes, I should have said that. In your table folders is a little summary of the emoluments clays. If you have questions on clause. If you have questions about it, can you before -- refer to that. If you have questions answerd to, that we are committee management expert, David Alpern is here and he can answer questions of a more specific nature. Don't spend a lot of time on it this sec, but I was caught offguard on this -- it as l the foreign travel business. I didn't know about it until I -- until I did foreign travel and was paid for by or requested to be paid for by another government, and I know, you know, there is a very technical part to this rule and you have to be careful about it. I want to make sure that you all saw that. But we'll look at it and not now. Now we're into the heart of the meeting, and for those now members of the committee on, the number onesh that we have -- one issue that we have identified as being most important for the life of this committee has been the effort around the appropriate protections of genetics discrimination in employment and health insurance. This has been's real key focus. We put a tremendous amount of our energy on that. To give us an update on genetic non-discrimination legislation and where the efforts are, let me turn to Agnes Masny.
Thank you, Rhode. -- Reed. I would like to take this opportunity to once again thank the committee on gent -- genetic antidiscrimination and to all the committee members for all of their input, and most specifically, to Sarah and to her staff and Amanda Sarata who has beenkceptionally opinion -- helpful in pulling all of these materials together you will be hearing about and most importantly, to thank the public for your continued input that has been so helpful in directing us on this important issue. So what I'm just going to, do we're briefly going go over sort of where we are to date with what has been happening in this whole area of genetic discremeination. I'll give you an update on of the recent developments that include the correspondence and what has been said to the secretary Leavitt, well as to a brief legislative updating what have is happening in the house. Then we're going to have a presentation by Peter Gray on the legal analysis that was requestedby this committee to loca requested by this committee to look at the current registration, what is the system where there are potentially gaps and we'll have a legislative briefing from Jamie Vickery from -- he's from the staff representative Judy Biggert's office, and we'll have a committee discussion to see what further things we need to do as a committee to move this forward. The task force members have been myself, Cindy Barry, Barbara Harrison, Leonard, reed tuckson, joann, Peter Gray, Tim leshan and Mildred Rivera. With regards to the congressional developments, thegenel -- genetic information and non-discrimination act was introduced to the house in March, and this was a bill sponsored by representative Judy Biggert and co-sponsored by bob Na where, Anna issue and Lee Slaughter and has a total of 101 co-responsers. What happened is after The bill was introduced, it was referred to three subcommittees. One to the energy and commerce committee, second to the education and workforce committee and third to the ways and means committee and the education and workforce committee has always life -- referred us to a subcommittee on employer and employee relations. The bill that was introduced into the house is very, very similar to that of what was passed by the senate, but it differd in only one way. And there were some provisions in the senate bill that addressed and potentially would amend the internal revenue code so those have been omitted from the house bill, and these were measures, though, that only affected church been plans, so there are some thinks that thea -- that at in the future, they could be put back in but currently, they have been admitted. We'll hear from, more detail, of course, from Mr. Vickery regarding the legislative update. So on to the correspondence that has been sent on to Secretary Leavitt is that after our last meeting, we drafted an encent on another -- incent on to another letter to the secretary, included in your briefing book and there were also four enclash ears support on. Once -- enclosures sent on. Was one was the compilation of the public minute. wanted to make a telephone book and received our own telephone books in the male, long with a dvd, that was a compillition of the public comments, summarized, though n a bridge that was not a total version. We're going to view that in a few minutes and there was a copy of the American health insurance plans letter of February 22nd to representative Been Booneer and an analysis we'll be hearing about shortly of the current law. So this was all transmitted to the secretary by the NIH director. So all of the public comments that had been received other by e-mail or mail or people that presented here to the committee between September 24th and November well as any research articles that were also sent to the committee. All of these were compoled in the book that was -- compiled in the book sent to the secretary. The content of the letter -- letter, we were urging the secretary, of course, to exert his influence and leadership to bring about an enactment of federal genetic non-discrimination legislation and in the letter, we reviewed of the stakeholders' perspectives. That was the perspectives of the patients, the general public and the coalition for genetic fareness, and it, in brief, we summarized the fears that the public has of the potential dis-- use of the genetic discrimination, healthcare decisions being shaped by fear rather than by best medical practice. Patients who are soaking Jeanetteic seeking genetic testing outside the formal health care system, patients anything that the results be captain out of medical records and opting for anonymous testing or foregoing testing that could actually prevent disease. There will be concerns about the lack of specific federal protection against genetic discrimination was also summarized in that letter.
O also pointed out the perspective of of the other stakeholders and consumers such as can A HIP and the chamber of commerce noting that these are complex issues and deserve further analysis. We recommend the secretary meet with any key stakeholders and groups that were interested in advancing this consensus building regarding genetic legislation.
Lastly, the secretary's letter gave a summary conclusion about the analysis of the current law and the goal for including in -- this of the law was to inform the secretary and provide a debate around the claims that the current law provides adequate protection against genetic discrimination. We specifically wanted to look at and analyze the law and identify if there were and point out where there were potential gaps. To date in summary, what was said to the secretary was that no federal law directly addresses the issues raised by the use of genetic information. The current law and court decisions does leave substantial gaps in coverage and offers inquest and certain safeguards and the current Avenues for relief were uncertainty -- uncertain and likely to lead to confusion and well, maybe costly litigation.
From the perspectives of the public regarding genetic discrimination, we put together the compelling testimony in an a bridged version for the public in our October 2004 meeting and we are actually going to view that now. Of about we do, I wanted to credit and thank those people who were instrumental in putting this DVD together and that is Scott and Peter from webconferences.com. Larry Thompson from the national human January only -- Gene and research institute and from the medical art NIH.
As I see it, genetic is the weather-tracking device of health. What if people were given the knowledge of a potential storms in their lives? How would they believe to protect themes? What would serve as the plywood for theuento windows and what evacuation routes would be made available to them. More fortunate -- importantly, how many lives would be save the -- saved. That's rate -- really the question, isn't it? Gene -- genetic testing as a disease-forecasting tool a potential to revolutionize medicine. The health benefits promes to be significant, but genetic information request also have serious implications for individuals, families and society. Many people are concerned about the possibility that genetic information will be misused in health insurance and employment. When people think that genetic information can harm them or their family members, they may decide to Gore go genet -- forego genetic testing that could benefit them. The committee produced this video to document the compelling testimonies of seven individuals whose lives were affected by the fire of genetic discrimination. They reflect a deep public concern about genetic discremeination and point out a need for federal legislation that would reassure the public that the misuse of predictive genetic information is prohibited.
Today, there is a current of fear reverberating throughout the genetic community. Not a fear of loss but Ritz -- retribution.
Fear and inuendo surround the world. People are afraid. Their fear keeps -- keeps them from being tested even when the test make the difference between whether they live or die. We put off being tested because of what the physicians recommended because of potential discrimination. Countless women in my family the last years have been diagnosed with breast cancer and several have lost their battle to breast cancer. could have all been prevented if we had pursued testing them -- then that. Griefs me thinking the loss of there that could have been avoided. I've decided that knowledge about my health is a gift. I want everyone to feel the freedom to have that gift.
After carefully way -- weighing the potential benefits and harms of disbren -- genetic testing, I decided not to undergo testing for consequences to my daughter. My fears are twofold. First, the information may not be protected and might even be misused. I also worry that if I test positive, my daughter might be obligated to disclose the perhaps of a judgeetic mutation and she might suffer future discrimination and health insurance and employment as a consequence.
As it stands now, if my children undergo genetic testing for human chromo-- chromatosis, they risk not be believe beingably to obtain health epshoorns when they're no longer covered under my husband's insurance. We're given a choice: Protect their health or livelihood? It's troubling to me as Americans we're placed in a position where we have to make a terrible choice. had a hysterectomy in October of 2003 and the proof Lake -- proof lactic mastectomy in March of this year and I'm still in the middle of reconstruction. It seems unfair to me that I am taking steps to keep myself healthy and to cancer in the future, and I'm being singled out and made to feel I am a liability. If someone in the company were diagnosed with cancer or some other disease, they mold not have been asked to switch -- they would not have been asked to switch insurance companies as I was asked. No one should have to force an insurance company to cover perfectly healthy children. In fact, I don't believe it should have mattered what their genetic status was to begin with. We're havable members of the community with contributions to make and shouldn't have to afraid our genetic anomalies, whatever form they a rise, will be held against us. I should not have had to spend a better part of six months wondering whether decision to have my genetic's verified by their pediatrician was a huge mistake. I shouldn't have to wonder if my children's genetic status is going to follow them into the workforce and render them unable to become employd in their chosen fields.
The reality is knowledge inage that you're carrying any particular genetic desorder, in my case, hemophilia and HD is just as devastating to you, your children and your grandchildren as the disease will be later. Open communication is almost non-existent between parents and their at-risk children regarding how they can better prepare to minimize the destruction of HD if they do have it. HD must be sequent -- scent shrouded in Chrissie to protect -- in Chrissie to protect everyone.
My mother had breast cancer at 35. Her mother died of ovarian againster at 41. Her sister had breast cancer at 42. I was 31 when was diagnosed with stage 3 breast cancer. My daughter, a 21-year-old s in this line, too. She, like me, and like another everyone in our family with this mouthing a, hide, that is hide, caps -- him. I.D.I., her genetic information even and especially from the healthcare providers likely to help her manage her lifelong predisposition to disease. Hiding integeral health information is the home -- only fail safe way to avoid discriminatory pro -- practices such as the loss or denial of health insurance or loss or denial of employment because there is no comprehensive federal legislation that patently forbids insurance or employment discrimination on the basis of genetic information.
Many people are afraid to come forward and fight for their rights to employment and health insurance which can -- coverage because they're afraid of the retribution that may not only be taken against them but could be -- taken against their families as L.
It's remark official -- artificial -- remarkable for me to realize the work my Parrot -- parents did in the civil rights the '60s was cot not completed then. Here I am working on the same issue, no matter the genetic makeup of a person.
In my opinion, genetic information is no different from any other essential KPC ting wishing distinguishing information about any human being, all of which, all of which is, by law, kept off the bargaining table that bares up this human rights based society.
We want to be heard, want to be protected, and we don't want to set in the back of the bus anymore.
National legislation that would make it illegal for insurance companies and employers to use someone's genetic status against them has, indeed, been drafted. As each day passes and the genetic common etwaits out for the house to bring this bill to a vote, scores of people across this nation are being persecuted on a basis of their genetic status.
Finding out your genetic status is p.m -- permanent. You can't take it back, and it's not something that you can change your mind on and what I really need is what we all need is a law that clearly defines the safety and the fact that you can't be discriminated against genetically.
Knowledge of our genetic risk poses many challenges for visits, families and society. These public testimonies reflect a deep anxiety about genetic discrimination and illustrate the problems that can result when genetic information is misunderstood and when people fear its misuse. the comb -- coming years, broader efforts will be needed to educate society to ensure that information about genetics is conveyd clearly and accurately. Although solutions to those challenges will take time, enacting federal genetic antidiscrimination slings something we can and should do right now. To address public fears about the potential misuse of genetic information in health insurance and employment. As these public testimonies make clear, federal legislate -- legislation will go far in providing Americans with needed assurance that their genetic be used inappropriately. Federal genetic antidiscrimination legislation is in the public and the nation's interest.
Reporter: Think that this DVD is as compelling as in its shorter version than for the testimony that we heard that day, and I think it was done extremely well. We will later in our discussion could actually look at what we'll be able toda -- to do even with the DVDs. More than one copy of course, sent to the committee members, there were 150 copies that will, the same number that matches all the numbers of the house that -- so that we can look at what we meet want to do with the DVDs. Okay. So, again, I want to just thank the committee because I think this sort of shows almost the fulfillment and the culmination of so much hard work regarding this issue, and I think it's very compelling and it says that we are moving this issue on and it hopefully will have some positive outcomes from all of the work of the committee. So next what I'm going do is turn the podium over to Peter Gray who is going give us the summary of the legal analysis and this was the analysis that was support on to Secretary Had sent on to Secretary Leavitt.
As Peter gets ready, let me introduce him. On Peter is from the equal employment opportunity commission, and he's, you heard, will review the legal analysis we commission. Now, understand and remind you all that there was a very important point that Agnes made, and that was that we have had some pretty intense discussions with all of the stakehold -- stakeholders who care about this issue, and one of the elements that really kept popping out from some constituencies was do you really need new legislation? Why doesn't the existing legislation solve the problem? Why reinvent all of this. I want you as a committee to also understand. Not did you see the video here, which we're doing, but this is -- we're an advisory committee, but we are an active advisory committee. We are engaged and so the conversations that we have had with different stakeholders in this have been to elicit an -- a date, positions and quite frankly, they have been trying to quite hard to tree to see if there was common ground and so where that common ground is. I want to be very clear to the committee. This is -- we're not sort of sitting back on this. We're trying to find common ground. Out of that need for trying to determine common ground comes this idea of, well, is it adequate s current legislation adequate? That's the context for this analysis, which was prepared by Mr -- Mr. Robert Landman, a consultant on biotechnology activities, he's sub squintly retired from HHS after three decades of service. He's not able to be here today, but we're glad that Peter consentd to prevent the analysis on his behalf. About the -- let me also acknowledge the agencies with jurisdictions over the laws analyzed, EOC, DOG -- DOJ department of labor and SACGHS and the office of civil rights reviewd this analysis for technical accuracy. We thank all of you around the table who had a role in that also. Thank you, Pete jeer. Yeah, good morning. Let me start right at the outset with a couple of little caveats. As Reed mentioned, was asked to present the report that Mr. Landman had prepared because he was be here. What I know about the health insurance part of this, what I know about health insurance is that I have don't know that much. are folks here who can provide you with some assistance if have questions following my presentation. S sec, let me note neither the contents of my report, the presentation of it or concerning it, especially during employment discrimination should be in any way seen as the EEOCs endorsement of the report's conclusions and during the question-and-answer, I can explain it and during the course of the presenting a, the report does reflect the commission's views on the legislation and I will reflect those at that time.
The report begins by noting at that the beat the Encinitasa senate and the house in the areas of insurance and employ hem. These gaps have become significant in the last few years because of the genetics in the science of and the what the areas of medical prodisbre.ses the deciphering of the human genome opened now opportunities for medical progress. The bill, the report reflects The bill's concern among the public, the fear regarding the loss of privacy with respect to quarterback isetic information and the -- genetic information. We curet sort of saw him drive home that point, and in this regard, I would note that some of you may have a couple of weeks ago, there was a new study for printd in the May-June Japetsics -- genetics, reported that 45,000 participants in this particular study raised concerns about po-- the ability to raise health insurance as a key concerns. The scope of the report, the report itself, if you look at it, contains discrete sections addressing federal law on health insurance, privacy of medical information, state law, federal appointment non-discrimination law, constitutional protections and protections geared toward federal employees contained in executive order 134145 that President Clinton seend in FebruaryThe security act entitled 3 ADA on HIPAA, and title of the ADA well as title of the civil rights acts of 1964. We're going to first move the hillk insurance part of -- the health insurance part of this. One of the interesting facts noted in that recent genetics and medicine study regarding the concerns of the public relative to genetic information in health insurance is that the fear of discrimination is lower among persons in the U.S. over 65 and among Canadians, generally. One segment of the study large number of Canadians. The authors of the study scug -- suggested that might be, because of Medicare for U.S. seniors and national health insurance for Canadians, where coverage is not at issue. For most the race -- rest of us as at -- as a report and this sleet note, health insurance is employment's bias. The report notes 60% of the U.S. population is covered by employer-provided health insurance and those insured by employers, most of these plans are covered by arisa and the health insurance portable and accountability act. The report notes that one basic purpose of HIPAA was to ensure that in some circumstances, individuals who change employers in -- and health coverage shouldn't have new coverage denied or Restricted because of a condition. An employer would be performed to impose error error limited re-- impose limited restrictions on coverage, based on conditions in certain parameters. The report further makes claim that under HIPAA, group health plans and group health insurance issuers can not impose a pre-existing condition exclusion the basis of genetic information unless there is an actual diagnosis of the condition reality -- related to the information. And the example noted in the report, an individual who tests period -- positive for the mutation in a Gene linked to breast cancer would not be deemed to have a pre-existing Dean in the absence of a diagnosis of breast cancer. As this slide notes, report includes a reference to the HIPAA rule limiting coverage plans on eligibility requirement or charging specific individuals more based on genetic information, so nothing bars the establishment of a group rate based on or in part on genetics information. The report states the HIPAA provision and the small group market prohibit an employer from refusing to renew a policy based on genetic information about an I'll enrollee or potential enrollee, but it would not restrict an issuer from taking genetic information into account when determining the employer -- employer's leave all premium and, the -- overall premium, and the report said a state could require an individual to take a genetic test as a edition of coverage, not to deny coverage, but for the purpose of determining the premium -- premium to charge the group and its members. In the individual mask -- market, HIPAA guarantees certain individuals who lost group coverage has the opportunity to purse -- purchase individual coverage without an exclusion based on geep -- genetic information. As I noted before with regards to the individual market report indicates although it can't deny or issue a policy, you can't have the premium based on whatever genetic information it obtained. 1346 -- some of what HIPAA does now, the report focuses on gaps or protection in the coverage. First as noted here, HIPAA doesn't promote a group health plan from requesting, purchasing or otherwise obtaining genetic information about an individual or require angindividual to submit on a genetic test as a submotion of coverage and on the basis of genetic information, the information obtained charging all members of the group higher premiums and the report states that charging higher premiums could make health insurance too lost -- costly for health employers and has the same effect for denying coverage. Other against noted, chording to the report, HIPAA protects don't -- don't apply to small groups. From what the report knows, these are plans with fewer than two per pace -- participants in the first district attorney of the plan year. Nor does HIPAA apply to plans that cover retirees only or to plans that elect under HIPAA to be exempt from the non-discrimination requirement, and I'm going leave it tokings to explain later if you need or want the explanations, what plans may make this elections to be e -- exE. from these particular -- exempt from these particular rainstorms. The report identifies as a significant gap the fact that HEPA non-discrimination -- HIPAA non-discrimination provisions don't apply to health insurance policies, even though then 10 to 15% much -- of those covered has such policies and even though the number much Americans seeking insurance outside of employment is locally to increase rather than decrease in the future. Hep, although HIPAA does guarantee certainly individuals who lose group health coverage have the opportunity to purchase individual coverage without any pre-existing condition or exclusion that I mentioned earlier. As I always mentioned, it doesn't prohibit issuers from taking health factors including genetic information to account when setting premiums. The report looks at the social security act and notes that federal law sets national standards for medicare supplemental or medicap policies, which are health insurance policy covering out-of-pocket costs in medicare, including insurance and deductibles and other costs not covered by medy carry. The supports state that medigap issues are prohinted from issuing the issuance or effectiveness of a Medicare supplemental policies or disium -- descrit -- discriminating because of health status claims experience relative humidity of health care or medical condition of the applicant, but, the report notes, that unlike HIPAA which exPressley includes genetic information win the coverage of the term "health information," that is not the report here. The report suggests there is ambiguity as to whether and to which extent a medigap policy might limit access to the use of genetic information. Title of the Americans with disabilities act provides that no individuals shall be discriminated against on the bases of disability and the full enjoyment of the goods, services, facilities, privileges, v or accommodations or any place of public accommodation by any person who opens or operates the place of a -- a public commodation. Places of public accommodation enshrewd -- include insurance offices. Chording to the report, the issue is not Little too of the physical application where the insurance is written, but rather the content of the insurance policies,ha what is covered by the policies and although there are federal court cases and some comments by legal scholars arguing that Title 3 rears equal ac-- requires equal access not only to insurance offices but the terms included in insurance policies for prevailing sense is that a ADA didn't -- doesn't cover the insurance policy. Most have ruled against coverage in this issue, and specifically, those include decisions from the third, fifth, sixth, seventh, 9th and tenth srkt. Only the first and second ruled the other way, and apparently the fourth and 11th and D.C. circuit have not yet ruled. The trend is clearly against coverage. The report notes that even if coverage might be included within title thirty twos protection -- title 3s protection, there is a separate provision in the ADA called the safe -- safe harbor provision that would limit the reach of the ADA. According to the report, the safe harbor provision means that Titles 1-4 of the ADA knar -- are not to be construed to prohibit or center -- restrict an issuer from classifying risks limiting risks based on or consistent with state law. A key of the safe harbor provision is that the term at issue not be deemed a subterfuge to evade the purposes of the ADA and most courts, deciding case -- cases under the safe harbor provision have take know a broad view of what it means. Some parts have even allowed you issuers of insurance, the use of insurance provisions that even lack actuariual justification, and the argument is so long as the provision in the insurance policy was adopted before passage of the ADA, one can't argue that the of that particular provision was, constitutes a subterfuge to evade the purposes of the act. On the flipside, the contrary argument is that the current use of a provision that evades the purposes of the act should be deemed or violated because of the presence -- present use of that provision. That argument has yet, has not gained currency with the courts. The report looks at the HIPAA privacy rule. It's relatively new rule, final regulations issued a couple of years ago. The rule establishes the minimum national stand fard -- stand tarred -- standard for protect the national health privacy information. The deafsition -- definition is quite broad, carrying all individual identifiable information which encompasses genetic information, including family history, and the covered entity is fined as including the health plan, health-care clearing house, health care providers and whoever transmits any health information in the electronic forum with the -- in a transaction covered by the HIPAA regulations. The reports suggest there are gaps in the coverage of the HIPAA privacy riew. basically, the privacy rule doesn't bar the use including genetic information, rather it merely sets the standards for getting access to the information. In this regard, the report notes that health information that could include genetic information is available for use in underwriting premium rating and other activities rating to the creation-or--- or renewal of the a health insurance and health benefit, and the report notes the privacy rule doesn't limit employer access to ole -- health a half -- information or genetic information and under the privacy rule, once -- once-protected health information is lawfully provided to an employer. It becomes an employment record and no longer considered to be protected health information. The support -- report looks at state law and it notes that there are many different state laws providing all sorts of differing levels of protect. The report identifies 47 states in the of Columbia that restrict the use, restrict or limit the use of genetic information determine how health insurance rates or individualil -- or group insurance rate plans. They vary in scope and genetic information. Some states, for, exclude family medical history from their definition of genetic information. to the reports, the three states without specific health insurance protection are Mississippi, Pennsylvania, and Washington. The report notes some states have enacted widely varying laws dealing with genetic information generally, and of these laws, the report notes that they treat genetic information differently, many of them, or most fright it from other medical roars, they folk -- records, they focus on the medical information rather -- rather than user or use, they safeguard information at different stages of the acquisition and retention -- retention and provide greater individual control through area -- varying means such as concept requirements, rights acts and civil remedies and property rights. The bottom line -- before I get to the bottom line. One of the report -- points to remember is with respect to the state law, regards to the laws that act the insurance is that they also contain different definitions what have copscouts en constitutes genetic information. Again, many of the statutes will cover genetic information resulting from tests and won't include family medical history -- history. So the bottom line is that different las provide different scopes of coverage and protection and allow different enforcement manages. We could have 20 state laws and 20 different ways of enforcing, different levels of protection and enforcing the law. I'm going move into the area of genetic discrimination employment, and re-- repeat my earlier caveat that I merely, the presenter and not speaking as if I could, officially, as an employee, the equal employment opportunity commission. The report notes as that as of August 32 states have enacted laws restricting the use of genetic information in the workplace and that nine states are considering such legislation. Most of these state laws establish greater protection for genetic information than for medical information generally and again, as I have said now, a couple of times, while the statutes do offer some protections in the workplace, there remains the problems that they, again v widely differing scopes of protection and definitions. And many of these laws do not prohibit or do not encompass genetic, a family medical history within the definition of genetic information. As the report notes and as we have heard earlier, there is no specific one federal law that directly prohits or protects against genetic discrimination employment. The main federal law addressing issues relating to genetic information is the Americans with disabilities act, specifically title of theThis slide sets forth the basic coverage of the statute. The three prongs of coverage. Prong 1 is, is -- covers the person with an actual disability. Someone who is major in life activity. Prong 2 is somebody who has a record of a disability and that'll be called Prong 3 as an individual who is regarded as disabled. Now, the report notes, and the slide notes, that the commission, the EEOC has interpretd the ADA as protecting against genetic discrimination. In the regard, the report cites to a 1995 EEOC compliance manual chapter in which the commission elaborate on the term "disability." In the compliant manual, we included an example of, regarded as discrimination that includes the following facts: An individual applied for and was conditionally offered a job and then given an -- a medical examination at which time it was revealed a genetic profile -- profile re-- profile revealed a susceptibility to colon cancer. It was a symptomatic. The employers saw the report and withdrew the job offer based on concerns of productivity and insurance cost and attendance. The compliance manual notes this would be considered a violation of the ADA under record -- regarded as prong of the statute of the were the commission's view, the person, employer was regarding the person as disabled. The report also notes that the commission settled its first case addressing genetic discrimination in 2002. And this is in reference to a case that started in 2001 involving the burlington-northing -- worthington railroad. Suffice to say it involved employers secretly testing employees to see if they had a genetic predisposition to carpal tunnel system. As it turned out, the test the employ ear was -- prom-- employer was using determined if the individual had a rare genetic condition acting one in 50,000 persons called heredtary neuropathy with palsy. Apparently carpal tunnel syndrome and one form of that share certain Kirk -- characteristics. There was a condition that it was not job-related. The standard that is to be used when conducting a medical exam of a current employee, and as the slide notes, the EEOC and bullington-northern e sent are you -- e -- eventually settled the place. No court was roard to look at, address the commission's view about regard with regard with regard to the ADAs coverage. Limitation, the slide discusses of the limiting as. Specifically, it notes the scope of the ADA has been narrowed since 1995, and particularly ge-- beginning in 1999, with respect to how the term "disability" has been defined. In particular, the report knows three cases and decided in 1999 and one case decided in in which the court said that employers, courts, excuse me, courts need to play, pay very special or careful attention to the person at the moment the employer makes an employment decision. Specifically it noted the ADA uses the present tense to determine whether an individual is impaird and if so, whether that person's impairment rises to a level of substantial limit on a major life activity. The key is that the language-defining disability should be read as requiring that a person presently, not potentially or hypoet thatically, can be substantially -- in order to demonstrate disability and the report suggests the upshot of the cases makes it unlikely the supreme court would fond a mere genetic predisposition to disease or disorder would constitute the disability. A person who is a symptomatic would beup to establish the disability under Prong 1 actual or Prong flight recorder -- record and, in fact, might be hard for the person to further establish a Prong 3 violation of regarded as. As an employer would certainly argue, they were not discriminating, that they were taking actions against the non-disabled individual who meet develop a future impairment, but they had no dis-- misconception with regard to his current status. Other limitations, the ADA doesn't prevent an employer from gaping access to your genetic information. -- gaining access to your gentic information. Specifically and in this context, the employer is permitted when, in the hiring process, to get information. Once an employer makes a condition offer of employment to an individual, the employer's permitd to conduct a medical examination of that employee, and there is no limit at that point on the information the employer is allowed to obtain. No limit. So if an employer wants to spend lots of money, you can get every genetic test available there. Is a limit presently with respect to what an employer can do with that information. Under the statute, an employer's limited to -- with respect to making employment decisions based on medical information conducted in the post offer phase of employment, but I will noise note this again, where an employer makes, withdraws' job offer to someone who is a simpom matic based on a genetic predisposition, it's at least questionable, according to the report, whether the individual would have a case, would be able to argue that he or she, whether the employer considered that person, regardd that person as disabled when are -- withdrawing the offer based on fear of future imper ma'ems. impairments. As for current employees, the standard that exists to conduct a medical exam is that the ems -- exam has been to be job related and consistent with thises int. Although it might be less locally the employer be able to meet the standard with respect to ordering a genetic tests, not outside the realm of the possible, for example, during the discuss -- discussions that led to the adoption of the federal executive order for federal workers, some agencies argued they should be to conduct a genetic test of current employees if they plan to assign an employee to a remote look. For example, to do a BRCA-1 test e even on an a symptomatic employee before Sonia Bittoning her a place where it would be hard story -- for her to getmed -- medical care. -- this situation could a rise in the post employment skinario, and an employer gets genetic information. And based on that genetic information, the -- before -- before it could sign to someone elsewhere it wanted to do a followup exam, and it mean hard to argue that moo might be hard to argue that that might not be job-related. The report addresses the more traditional defenses available to employers in 88 case, reflected on this slide. The report notes the EEOC expressed support for legislation addressing genetic discrimination and even though the commission has and continues to argue the ADA offers protection against the genetic discrimination, doingez who sends her -- dominguez testified before the senate health committee in 2002 noting that the application of the ADA to genetic information is less than clear and because it's less than clear, both individuals and employers need understandable rules. So -- so that they can be guided in the future with respect to how they am and use such information handle and use is such information. The report looks at Title of the civil rights act, prohibiting discrimination as note on the slide. It reports notes that if an employer discriminates on the condition of a descrate protected group and -- discrete protected grief -- group, and here, for example, those of Jewish-Egyptian background Indiscernible ] If a employer were to select a specific for genetic testing, say women werum, only for -- women were only for BRACA testing would violate title 7. Title 7 doesn't bar use of genetic information or testing. It just prohibits treating discrete groups differently with respect to that testing. This slide on protection references a case that is discussed in your material called blood cell force the Lawrence Berkeley lab, it's on pack 20, and in that case, talked about federal constitutional protections, um, but again, you you should night that federal constitutional protections are eliminated in that it only applies to governmental action and that there is a way -- weighing in that goes on between individual rights against the public health or, interests of the government in taking action. So it's quite limited. Protection for federal employees I referenced earlier, executive order 13145, applies to federal workers butp forcement of the executive order requires use of the rehab act in that the, there's no remedy for a violation of the executive order itself. So, unless the conduct also is deemed to violate the rehabilitation act, um, the protections included in the executive order are not enforceable in a court. And in the report's conclusions, um, that the report notes there is no one federal law addressing access to and usage of genetic information, but the laws out there that might be used have significant weaknesses and gaps in their coverage and in the ob-- absence of a federal law, we may enterad about -- period of litigation, using the different and divergent federal and state laws, spending a lot money and time trying to figure out what kinds of protections the laws offer, and at the end of the day, finding out for all the cause and cost and time, there is little that -- cost and time and there is little that protects the use of genetic inform aismghtzy believe after the next presentation, there will be an opportunity for committee comment and discussion of the report. Thank you.
Thank you. very much. very much for a very excellent presentation and for a significant body of very great work. So the next, sir, we're going to.
We're happy we're able to be joined today by Mrs. Jamie Vickery, who is a legislative assistant from the office of the honorable Judy bigert of, U.S. of Representatives. As you heard, representative Biggert is the original sponsor of the house bill and it's very timely that we hear some perspectives from some sort of, from the Hill and how you all see where the status is. free to present either from your chair there or from the podium. you very much for taking the time to join us.
Good morning, thank you for giving me this opportunity. I'm pleased to be here this morning and it's nice to be able to get off the Hill. I feel like I have been chaind to my desk and forgot what fresh air and sunshine feels like. Let me warn you, of all, I'm not a scientist. There is a reason I was a political science major and not a hard science major, so I'll leave the nitty gritty details of genetics to you, all the scientists and researchers in the room and focus on the political efforts prevent genetic desitemination. Now, as you know, my boss, congresswoman Judy Biggert, along with Lo -- Luis Slaughter of New York, Bob May and have introduced HR 27, the genetic non-discrimination act of 1995. Congresswoman Biggert is the of the subcommittee on energy, the subcommittee with jurisdiction over the human genome project. I don't have to tell you all the sequencing of the human genome was one of the most excuse me -- significant scientific break-throughs of the past century. The implication of the of the brackthrough are mind-boggling. Because of the genetic testing made possible by the discovery, individuals can, for the first time, know their risk of developing more than 1,000 genetic disorders. They can adopt better habits such as exercising, eating better, going to the doctor or going to the Jim -- gem to lessen the impact of their condition, and they can mentally prepare themes and their families for what may happen down the road. However, as we -- have heard today, the ability to protect excuse me, to predict disease through genetic testing and family history opens the door for terrorist-- discrimination, particularly in the employment and health em-- insurance field. When individuals are afraid this information be used against them or their families, they will not be tested and the research is not being used to its full advantage. Some people have said they won't want to know. No doubt, finding out that you or your child could suffer from a debilitating disease could be disconcerting, but this should be an individual's choice to make for themselves. The fear of losing their job or health insurance shouldn't be a factor. As we just heard existing laws, including arisa and HIPAA are unclear on the topic and are no more -- more than a patchwork. To be frank, they're Swiss cheese. This means in order to protect -- protect an individual's privacy, we have to enact legislation prohibiting specifically treatment the basis of genetic information. That's why it's important to get HR 1227 passed. O Pope -- opponents say it's not necessary but the solution and need of the problem. No one should lose their job or health insurance before we enact legislation. Specifically, the bill prohibits employers ear health insurance from making employment or coverage decisions based solely on someone's genetic information. The bill's very, very similar to the bill, Luis Slaughters introduced into congress. However, we realized that given the current political climate, a bill introduced was probably not going to go very far. So she and her staff graciously let Congresswoman Biggert take the bill N. keeping with the current political environment, we have made a couple of little changes to make the bill more business friendly and make make it easier for republicans to get on board. None of these changes substantially change the bill or take away any of the enforcement make nisms. The bill places limitd limbs on the amount of damages a employee can see based on the sides of the company, and contains protection against frivolous or opportune lawsuits. It includes so-called water excuse me -- watercooler gossip. If your office is anything like mine, everybody knows everybody's business and it's not always true, and there is nothing your boss, much as they try to control it k do about it. This is the exact same legislation that passed unanimous lein the senate, and it's strongly supported by the bash administration. So what is happening with theble? Unless -- unlike the senate bill that went through the health, education and labors and pension committee, the house has been there through three committees: Education in the workforce, energy in commerce and ways and means. Because the non-terrorist -- nap discrimination provisions apply to the medigap insurance people can by to cover -- buy what medicare doesn't cover, ways and means needs to soon off on this bill. One tiny provision the bill and it goes to a separate committee. However, the ranking member the exul -- full committee, Charlie Rangell from New York, and the chair of the house subcommittee Nancy Johnson from Connecticut are both cosponsors the bill. I don't think we'll have a problem in ways and means. I'll be honest with you. Like I said before, there are some in business community that are opposed to this bill. Andol the education and workforce committee held a hearing on non-genetic, non-discrimination in July of last year, nothing -- nothing more came out of it. The business groups are afraid this new legislation the set up a new regulation on how they do business or that it will create an administrative burden. Let me assure you, this is the last we want to do. This is -- Mrs. Biggert is a member of the education and workforce committee and a member of the employer/employee relations subcommittee that has discuss -- jersey deck over this bill. -- jurisdiction over the bill. She understands the concerns. We're trying to work with the business groups to address their concerns -- concerns without taking away any of the guarantees of genetic privacy. Although the groups are still opposed, they're not as adamantly a -- opposed as they once were. Some cautiously optimistic they will drop a neutral stance and not work against the HR-1227. Right now, we have 105 co-sponsors. When you consider there are 435 members of congress, means we have gotten a quarter of them on this bill. However, the problem is that a majority of the cosponsors are democrats. We have 74 democrats to only 31 republicans. The republican-controlled congress, that is not all that helpful. This is a bipartisan bill, and we need the cosponsorship to reflect this fact. So right now, we're focussing on getting republicans cosponsors. For a lot of members, it's a good way to show that you are pro-patient, pro-medical research without having to deal with the sticky stem cell issue. It's also a good weigh for members with large genetic labs or biotech companies to show their report -- support for their constituency in their district. Ideally, you would hope number -- members would get the bill because it's a good think this to do. In reality, you have to sell a bill for what it can do for a member. That's what we're trying to do. Here's where you all come in. Now, I know it's sort a delicate position because working for the administration you can't really lobby for the bill even though the White House does support it. I would encourage you to let agency leaders, including Secretary Leavitt how important this bill is, and encourage them to encourage house leadership to get the ball rolling. I know the President strongly supported, there has been several excuse me, there has been two statements of administrative policy in 10 8th and 109th congress, but we haven't heard much from the White House other than that. They're not being, getting role involved. Anything that the administration can do to sort of kick leadership in the pants on this would be very helpful. As you know, this issue's been around for quite sometime, and, in fact, congresswoman Slaughter's introduced this bill or something similar to it in every congress since 1997. This is theeing for thest we have ever come in the legislative process but we still a long -- a long way to go. I'm confidents this the year we can finally do it and protect individual's genetic privacy. We all know those provisions are long overdue. I know you have a lot to fit in today, so I'll wrap it up. Once again, thank you so much for this opportunity to be here with you today and thank you for all that you have done on this issue in bringing it to the forefront. I look forward to working with all of you and getting this bill passed. Thank you.
Well, very much. We very much appreciate your taking the time and also your offer that be able to continue to be connected to not only to the congresswoman as well.
Yes.
I think now with that, and if can you still please join us at the table still, we would appreciate it. The prior -- floor is open for some discussion. By the way, I want to say that we, we actually don't quite work for the administration. We are ad-- advisory to the secretary, so that gives us a little more latitude and I'm glad you that sort of put that there so we can underscore, particularly for the new members of the committee on, again, that we're an advisory group to the secretary and there are certainly some constraints there, but there are multiple opportunities there. -- floor is now open. Ed, I so in our rand -- hand.
First, I want to thank you for coming and and presenting and please take our thanks to your boss as well f -- for sponsoring this something that has in the six years I have been involved on advisory commitos, it's been one of the top issues for both administrations and each of the secretaries, or at least we have take know it to each of the secretaries. Please, please thank your boss for response organization this. You gave us some guidance in terms of how we could help. How do you think -- the opposition is, is the opposition, you oon use said, you think they may go neutral on this. Is there anything that needs to be done in terms of getting more support from appropriate business-friendly groups to help with is -- with this.
We are actually working with those groups, like I said before, and they probably have about 10 concerns. And, you know, there are certain things we're happy to set down and negotiate with them. There are some things that are not negoteable and, it's a matter of finding something that people can live with on both sides of the aisle. Basically our strategy root now is to get as many people on as we possibly can. The harder, excuse me, the more people have supporting the bill, the harder it is for groups to oppose it. Politically and PRwise. So, at that, that is our strategy right now and focussing on republicans, focussing in on bringing people in any constituency, people affected by this, think this of the -- it's hard to say no to people from your district and hard to say no to sec people.
Yes.
As a follow-up to, that those of us Tateing -- rotating off the committee, when is the last day of the service, the end of the meet something okay, you very much. I'm taking a mini sabatical, and the, I meant representatives in the,who is a republican for the district in which I have a small business in Colorado. And so I may pay him a visit then as I am -- .
We'll get you everything you need to go
Excuse me?
Come see us and we'll get you everything you need to go in and meet with hep.
very much.
Agnes.
As I mentioned earlier that one of the options that we have is we actually have 150 of the CD-ROMs, of the testimony the public and maybe what we can do is to identify the people that were previewd in this public comment, what areas they came from and specific local -- specifically, Sunday it to those representative -- send it to those republicans and, of course, may be to the, all the house members as well. We can't send it, of course, but we can recommend the secretary, of course, send it on to them. we could highlight what areas those people who spoke, what areas they came from.
Great. We've got in the queue, Francis, Emily and julio. I want to make sure, though, that Jaimie been given a copy of the lead -- letters we have sent to the secretary already, and if we have not, Jamie, iffy -- you don't have those, I will see someone who has a handy copy around, they can handle -- hand it to you to take it with you when you go. Obviously now, we're thinking about the next step. I want you to know we're pushing hard in that regard. Francis.
I would also like to express my thanks to representative Biggert and to you, Jamie, for being here today to stall -- tell us about the status of this. Having worked on this issue, some of us for more than a decade, it's gratifying to see the activity that is going on this year with the unanimous vote in the senate and now The bill being introduced in the house and at least assign to committees, although I guess I would like to hear more about yourm pregs about whether hearings are likely to happen. Because without them, it's generally the conclusion that not much forward motion is going to be occurring. I mist -- I must say I'm deeply disappointd to see the opposition that. Seems to be largely responsible for the current logjam coming from the business community. After all, as pointed out in the 19 error-- nice presentation by Peter, a very large number of states have passed investigation -- legislation that prohibit the use of genetic information in hearing and firing and promotion and to our knowledge, there has been not a single instance that legislation has led to frivolous I think has been one the communities concern's coming from the chamber of commerce and the national -- national -- facial association of manufacturers. The evidence for this being a risk to the business practices doesn't appear to be very compelling, and the argument the need for this is night -- nicely outlined in the democrats we heard here and reproduced on the DVD are from the public's perspectef and iseral very compelling. So, I guess I had two is what is your estimate about the likelihood of hearings and the second relates to rumors that one has heard that perhaps the bill would have a chance if the employment provisions were stripd out it was reduced simply to health insurance protect. I want to comment I don't think that isma -- what the public is looking for. If people are anxious about genetic information and how it mean used against them, employment is clearly a serious issue. It's not just about health insurance, and I think that would be in unfortunate to see that particular the bill lost in this particular shuffle. May be can you comment on whether that particular idea of recrafting the bill it only to health insurance is something that is likely to have any legs at the moment, and as well if you could comment about the hearings.
To answer your second question first, you know, there has been legislation introduced previously that was just healthI am not entirely sure that that is something that Mrs. Bigert and Mrs. Slatter are amendable to, from what we have heard. The insurance excuse me, the insurance industry is not nearly as opposed to it as the business community. So would be easier to do, but I guess -- guess it comes down to something, or to the question of do we want what we need or do we want what we can do and I think that, you know, from everything we have heard, the employment Aron Katzmana s where the problems seem to be cropping up. And that, I think, that's, we need these, the employment issue as well. To answer your first question about committees, from what I can tell, the committees are more opened than they ever have been. Certainly any workforce had's hearing in July on had a hearing in July. It's hard to say what committees are going toco -- to do and what they're not going to do. It did pends on what sells on the sleight on this timing and we have had a schedule of congress and all I say is we're working on this and they seem to be more amendable to moving this bill than they have in the past.
Good. Thank you, and let me make sure that I understand also, Jamie n this regard, the -- is there any active discussion with the employment community around, are there ways in which the bill can deal with their concerns regarding frivolous or unnecessary lawsuits. It's not even, as I understand their position from, we did a lot of work with listening to them very carefully, and they were generous about their time and helping us to understand it. It's just, as I understand their position, it's just as the public is concerned about the potential fear and misuse. They're concerned about the potential of frivolous lawsuits which, is important to their conduct or their opportunity -- activities. Are there any, is there any sense offence is tist to the concerns, there any way in which The bill might modify, when someone takes into account those concerns. That was something that was brought up with the SlaughterBle in the 10 8th congress. If you look at the, excuse me, the current bill, 1227, there are some provision -- provisions in there. Yes, the exhaust administrative, excuse me, there are certain steps that have to be followed before you can take a claim to court. And also, it's broken down into three categories, the amount of reward that can be a -- received. There is a limitation on awards based on the size of company. So, obviously, if you have a problem with birks -- ibm, ibm is going be able to take care of that claim more than a mom-or-pop Goldman Sacher -- bakery, or something. We're still open to negotiating with them to, like I said before, it's a matter of finding the balance between still having affected enforcement mechanic theming mechanisms and the same time, finding a way for you to make it work for business people. Thank you. Emily.
I think one of the things this committee has tried to do in the past to move the legislation forward was to understand what the objections were. And what we had heard previously was that there were two objections. One was that it's not really happening. We have testimony. We have a dvd. -- a DVD. Please use these tools. The other comment -- comment we heard was there is adequate protection under the law. We commissioned a report to really review that in a very analytical way to look at what actually are the existing protections and to create a set of data that could be presented again in a very analytical way to individuals who are making those kind of, just brush it off kind of comments. We don't need to be wasting our time with this. There are other things that have taken care of. Are there any additional points that we could address very specifically through the mechanism this committee has, which is basically public comment and the ability to commission special reports of the state-of-the-state that would be helpful at this pot in time to move the legislation forward.
I think the report is going to be phenominally helpful. Again, like you said again and again, people are saying oh, there is existing protects in law is HIPAA. HIPAA taking care of it. Arisa is fine. There are already pro10s in the law. To be able to present them in a precise and say, you know, this doesn't cover this, this doesn't cover this, this doesn't cover this, it's going to be tremendously helpful. As there was some way to Sunday that out to the hill and in a very concise, very format that staphers could at and we could use could be incredibly helpful, getting people to understand there is really no legal protection.
Okay, and the other question I had for you is of the individuals who have not yet signed on, havey that not yet seened on because they just have not yet really been educated and come to a decision decision oh -- or they have not signed on because they're opposed to specific reasons.
I think it's a combination of both. We have certainly health, staffers are overwhelmed. The stem cell issue on the hill consouped everyone for the past -- consumed everyone for the last three months, it feels like. Sos that -- settles down and people are starting to move on from that, I think this is people time to educate members on the importance of the legislation. Reporter: Just want to clarify one thing that I think you just said in responsibility-- response to Emily. Sarah, let me just make soar. Sarah, let me make sure. I want to make sure you heard year -- clearly. I think you alluded to it, but I want to make sure you're specific. Did you actually request we send your office a copy of the analysis that we have done?
That would be incredibly helpful. I would very much appreciate's copy.
I just wanted, for the record to note, that we have been asked to Sunday a copy of the report to the congressman's office, and we'll be happy to do so. Thank you for the clarite. Julio.
I have a question on the same issue, which is whether it's been abrupt or become problematic, kind of where does, um, like a pre-existing condition, you know, where does that begin and and what is left over with actual to nextitiving. other words, can you get genetically tested and be shown to have a predisposition to a disease you kept have yet, or -- you or you can already have the disease and also have the Gene. And for pre-existing conditions, it's traditionally, healthcare has been tradition problematic, and that is the genetic testing that is discussd in the legislation overlap with this wish issue of pre-existing condition. other wordsia, we talking about only the tests for someone who is healthy, or a test with someone who may already have a condition.
I'm from the labor department. Maybeec speak up. Writ -- it may seem random a labor department person is speaking up, when Peter talked about the HEPA probable provisions and protects they have against sort of in health insurance and health insured based coverage, plans, restricting coverage based on the fact that a condition is pre-existing, I think the analysis that we have done supports the finding that pre-existing conditions, once you hull -- actually have a condition, I think you're pretty clearly within the HIPAA protects. What is unclear is if you don't have a diagnosis of a condition and there is just genetic information, there are still a lot of gaps there and I think that's what the legislation is looking to address. There is a question whether or not a attending provider or a licensed medical professional has diagnosed the condition, then I think you close -- cross the line into a pre-existing condition and start where proy thees apply. It's up until that point there are a lot of gaps that I think the legislation is trying to address.
Our ex officio is terrific. Yes. I can clarify whether the request is for the legal assessment report or whether you're also requesting our telephone book of the public comments. And whether you have that already and whether that would be useful for distribution?
I would actually like both if you could -- I, I -- we appreciate both of them.
We appreciate -- appreciate. We're very clear on what the request is. Thank you. Any -- yes.
I would just encourage those who are, speak on this issue, include in your talks. One of the first things I did when I received the telephone back in my office was take a picture of it so that one could see the thickness of it. Because I think this has been an issue that why, why develop budget legislation when there is no discrimination. I was on record at the last meeting for saying that the individuals who have written and their judgeetivity iss, they're -- and their genecitists, my colleagues, have wren this is not a problem and should be a shamed from of themselves, and I have -- have received comments back from them arguing I should not say that. I'll go record saying they be ashamed. It's when you catch the fox and hen and him doing this he he's visiting, and why he have blood on his and he said cut myself shaving. you know, you don't ask, you don't ask the insurance companies whether they're discriminating. were going to say?
Um, let's do couple of folks here sort of wanting your picture. Not your picture, but -- [ Laughter ] -- the picture you took. They probably want your picture, too. If you would Sunday that around to the team, I think everyone would appreciate it. As we bring this portion of the meeting to closure, let me just try to get, again, we have a couple of seconds before the break, but I want to make sure that we are clear on the next steps here. I think the committee has gone pretty far in terms what have it can do. The secretary now has the materials that have been referenced, he has the letter. We will, of course, use every mechanism to keep that in front of him from moving forward. And what I want to sort of get a sense of is is there anything else left? I still would say to you, Mrs. Vickery, that if there is any role that we can play to, and I don't think that that's -- I'm volunteering it or saying I think there is, to help try, to again, look at whether -- where of the opposition, quote, unquote, is, and common ground trying to, grape, get -- again, get language that helps to met date -- mitigate of the concerns they have that are not related perhaps to the issue, but more of the unintended consequences of the issue, and that's really what I think, I'm hearing a large part on that community. It's the -- it's the unintended concerns about the legislation. If there is a role that we can play in terms of brokering, talking, clarifying, mean I think we really want to get there and so no -- know that the committee is open to whatever role we can appropriate lay play within the confines of of our charter and responsibility. A couple of quick thoughts to get us, we have other next steps and only that. One, two?
Did we specifically, from Agnes' comments d we specifically ask the secretary to do a broad disk of the public comments and of the public comments and the legal analysis.
Let me read the letter we'll quick.
Can we do that or recommend it, ask it of the secretary?
Actually Dr. Zahoney in transmitting the recommending as the committee, suggested that that the secretary do that. So.
Good and --
Just a point of clarification. Can we or can we not as individuals contact our representatives, especially those who might be on the wrong side of the picture -- particular issue, long as soon as we don't make fact that we're members of the advisory committee?
Yes, as long as you don't do it today or tomorrow.
All right. Yet -- yes. Last comment.
And in our last summary, we had made a recommendation to the secretary that they pull together the stakeholders to actually analyze of the disconcerns from the business community and I don't know if that's been moved on or we can say something to the effect. To mention in the reports in the public comments we have had when the coverage and reimburse issue -- reimbursement issues, there were several organizations that voiced their support for the antigenetic discrimination legislation. One of which was the American academy of actualaries, the other the American association for clinical chemistry and I'm just wondering whether we should, you know, kind of go through that report and pull out even some of those comments and if we were going to send on another report from this meeting, to sort of e keep say that we have received further comment from the business commune -- community and that maybe some of these organizations could be included in the steak stackholder meeting, if, market that's where that would go. [pausing to switch captioners][ Captioner needs audio. Please hang up the phone so the captioner can dial in. Thank you.
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On the role of fda and monitoring such marketing and third that recommending that hhs collect data on the public health impact and collaborate with the federal trade commission on the monitoring of such advertising. In march, we received a response and you can five that in brief five of your briefing book. Since that time, there have been some efforts to address our concerns. During an interagency conference call on this topic in April, two working groups were established to respond to our recommendations. We will be hearing updates on those working groups shortly. Following the working group updates, Deborah wolf from fda's center for devices, office of compliance is with us, and we are happy that she is able to prie provide an update on fda's role in monitoring marketing of genetic tests and services. Before we hear Deb fwra's formal presentation, I'd like to ask Matt Danerd and Deborah wolf to update us on collaborative efforts to monitor such advertising. So Matt and Deborah, can you give us that update, please?
Thank you. Yes. Matt Danerd. I'm happy to report that the fda, etc NIH task force is up and running and working well. Due in large part to the people sitting next to and Faye of NIH. What they have done is put together a wonderful chart that has potential targets on the left side. There claims somewhere in the middle a synopsis of the science supporting those claims potential consequences both health wise and economic and they presented that to me and we had a telephone conference about that. I comments on -- commented on those on what was good and what we needed. What the FTC needs in this area since a lawsuit here, if this is what we're looking at down the road, would be an entirely new application of the FTC act, we need the proverbial slam dunk. We don't want any scientific issues anybody on the other side could debate. So this is what we're looking at. The nda and -- fda and NIH are going back to doing a little more work which I am eternally grateful. They're going to come back to me after this committee meeting sometime in the very near future and discuss it again. And when we have a consensus on good targets, I'm going to take that to my folks in advertising practices and say, listen, I've told you about this. You've been a bit excited. Here are the potential targets. Hopefully I'll be able to say this is a good case, and if they agree, we'll take this to a bureau of consumer protection folks and get their head's up sort of agreement and we'll take it from there. You have to realize that unlike the fda, our hook is not simply the public health, although that's an enormous criteria in our case selection. Our hook is advertising. We've got to find a strong claim, which is not supported by competent, reliable scientific evidence and then we take it either to court or administrative law judge. Part of that, of course, scenario is, well, when's the potential public health consequence? What's the economic consequence? How strong is the claim and is the science? What we're looking at are claims that some of these tests can help you lose weight over the long term or can help you determine whether you are susceptible to serious diseases like cancer or that they can prescribe a nutritional diet for you in the future that, in fact, will help you avoid some of these diseases or avoid obesity and we're fda in particular is checking into the science on these and how the tests are performed because that does make a difference as to whether they are -- how predictable or projectable they are. So they are doing all this work, and it's quite wonderful. I think we're off to a good start.
Matt, thank you. Let me ask one quick question. Given the ones we've seen in terms of facial cleaning or this addictive behavior, does your child suffer from the predisposition to alcoholism, drug abuse or learning disabilities, just send in your swab and we will give you the right nutra suiticals based on this genetic profile solve the problem. There are interesting examples out there. I guess where I'm sort of struggling with is wondering why you are having such a hard time finding or narrowing down on the right test case.
Because what we're talking about are specific facts. What is the exact claim? What is the science supporting that claim? How serious is the condition that the test that the advertiser purports to claim that test is going to show you? An addictive behavior that affects us all and we're all concerned about that, but the kind of claims that we deal with on a daily basis are cancer cures. Aids cures. Bogus HIV test kits, which we just did with the five-dayhat's the kind of claim that gets our attention.
Again, I'm glad you are moving forward. of the things I must say as we list ton Maureen who's coming next, and then we have questions after that, is apparently observers in prominent scientific publications in commenting on this process have decided to label our activity moving at a glacial pace. While they are pleased we are doing things, apparently we are characterized as moving at a glacial pace. Hopefully, whatever commentator that wrote this after this meeting decide that maybe we are at least moving at a more aggressive glacial pace, but that we are trying to do this seriously. Let me also take this opportunity again, for the new members to remind you, there are a lot of people that pay attention to what we do. We may not always agree with how they interpret our activity, but we are being interpreted. Be mindful there is a lot of scrutiny what we are doing as it should be. Newing from cdc. Thank you, Reid, very much. Actually, in that same article, I was quoted as saying that my friends at the fda are doing nothing, so that tells you how your words can be distorted. So my apologies to the fda if my words did not -- said the wrong thing at the wrong time. Anyway, we had a conference call last week to begin the process of discussion of how hhs is going to respond to kind of collect data on the public health impact of the act consumer marketing of genetic tests. And we have a working group that has a representative from nhgri, fda Joe Hackett serves on that. A few folks from the cdc and I would welcome any of the new members on this effort because our work has just gotten started, and I want to thank Sarah and the SACGHS staff for keeping us on target. Our job is not as easy as it seems measuring public health impact has multiple facets to it because you have to define what that means. And as I said, we had a brainstorming session, and at the outset, we kind of decided to break into two groups. The two types of tests, if you will. The ones that are squarely within the health care dliivery systems where you have direct to consumer advertisement that is done within the context of health care providers examples of this is the back to one analysis campaign that many did a couple of years ago. Then the other ones are the ones that are outside that system because it impacts how we can measure impact if something is in the health care system as you mentioned with the public health response with the back to one analysis campaign. Presumably, if people do this outside the system, then there is really not too many immediate ways of finding the outcomes or impact of such advertisement. But we kind of began to kick around a few questions. Obviously, the ultimate impact is find out the outcome of people are tested, not tested, whether people are being helped or served by such ddc targeting. And I think it may, as I said, it would be a few steps before we can devise the kind of data collection instruments to get there. There are a few more, I guess, what I call process measures that one can use. One consumer's knowledge, attitudes and behaviors. Whether people have heard about these things, and whether it's affected their knowledge or their behavior in seeking them and why they seek them and who are they, and or not the outcomes have changed. So we started that discussion, and let me just give you a quick summary of, in your tab, I there is an example of a public health response to the back to one campaign that was an actual experiment. It happened in an intensive way in six-month period in two cities in U.S. in Denver and Atlanta. At that time there were at least two responses that happened. We partnered with health departments Colorado and Georgia to mount surveys to health care providers, and women of the right age group. Random surveys to find out what's going on. There is an mmwr article in there and a peer reviewed publication on its way. same time, Keyser in Colorado did a similar are analysis in the Keyser community, and they have the advantage of using hmo is that you have a closed system and it may not be representative of the population, but you know referral patterns and the paper and genetics and medicine just appeared in March this year. You guys can peruse it. And at both of these surveys showed an impact of such campaigns. I mean, it's a no-brainer advertisement works. It makes people think. It makes people act. Whether it changes outcomes or appropriateness of referrals, that's something to be looked at, but during our discussion last week on the phone, we kind of began think about the ways to essentially tackle the problem. One way, and I'd be curious to get some more input from the committee here. One is to partner directly with these companies. And we were cautioned to work more with the other subgroup here because on the one hand, if some other part of the government is pursuing them, I think partnering with them to seek data on who uses their services and obviously there are privacy concerns and business practices that may not allow to us do this, but for us, I think finding out why people use these services and what the impact of these services are on their own health is what we're after to try to document these things. So we decided to shelf it for the moment until we figure out what the other group is doing. We talked about networks as a good place to do these kinds of activities and surveys, and would be trying to pursue this. But of course, this methodology would miss outof pocket purchases and direct access. other words if it doesn't come back through the health care providers and be in the chart, there's no way you can capture the impact of such a practice. The third methodology is to piggyback on existing surveys that cdc and state health departments do on an ongoing basis. of the surveys cdc does on a yearly basis is the health star survey, which is a random sample of a representative sample of the U.S. population about 45,000 people, and we're going to be adding dock styles this year, which is a random sample of physicians to find out what people do and what practices look like. And again, if the magnitude of the issue is small, I mean, 4,000 people may not to pick up if it's only one person in 5,000 that use these services, it would be very difficult to pick up. But at least establishing baseline rates of different things will be important and you can track it over time. Now, of course, states have different surveys. One of them is the behavioral risk factor surveillance system which is faith-based survey, and we will be looking to part with several states to evaluate that data collection systems as long as we are able to devise sort of minimum sort of co-elements for how we can do this. So anyway, we are going to be exploring different things over the next few months, adding questions to existing surveys, both state and federal, and working with hmo's and I look forward to working more with different members of this committee and trying to get a better handle on this public health issue.
Great.
Thanks.
Let me just march into the presentation and can I come back we'll do the questions at the end? Is that all right or do you have something that's really
It's very brief and it's appropriate now. I would suggest that Emma Maris who wrote the piece you commented on before for nature and genetics, that you contact her, Mr. chairman, about the genetic nondiscrimination since this seems interested in genetics.
Good. Thank you for connecting the dots. That's great. Let's move now, then, to Deborah Wolfe's presentation. Deborah is going to update us on the fda's role in the oversight of direct genetic market with tests. She's with the office for compliance at fda and then after Deborah's comment, we'll come back and put all of the pieces together and determine, as you listen to what she has to say and what you heard, how we might move forward in terms of our agenda in this regard. Deborah, thank you so much.
You are welcome. to be here. Good morning, everybody. I want to make a couple of quick points before I start my slides. One is that I would acknowledge that we do work slowly in general, and I think in part that's because of the bureaucracy itself and the way government works in general. Part of it has to do with resources and part of it has to do with these issues being complicated, and there's not always consistent opinion or agreement inside the agency or within the department. So these things just require a great deal of discussion before there's really a movement. The other thing I want to say is that my presentation including a lot -- includes a lot of references for statutory and regulatory provisions. I hope that you don't find that off-putting. I think here, a lot of the specific language in the statute and the regs is important, and why I did it this kind of legalistic way. Okay. Direct to consumer marketing of genetic testing is taking place in a much larger context of direct to Conner -- consumer marketing of all kinds of medical products and services. So I think that's one part of how you look at the entire field of, you know, consumer reaction, what prompts consumers to go have a specific test done? There have been a number of studies done on the impact of different aspects of dtc marketing of drugs especially, and there really are a lot of mixed opinions in the consumer and medical communities. The advertising and access of genetic testing raised concerns that are different from those of advertising direct access of drugs and medical devices. Some of them are the same in terms of who is making certain decisions, what kind of guidance they have, but they're also, as we heard, a lot of much larger consequences. And fda's role is uncertain. Inveet troa diagnostics provide information rather than treatment, so when the agency approves or clears a diagnostic test, the safety and efficacy are reviewed in a different way or viewed differently from the way that they would be viewed for drugs and devices that are used in therapy. The consequences are the ones, you know, remove the test itself, generally isn't causing any sort of danger. It's what happens with how good a test is, how reliable it is, and what happens with the information you glean from it. Okay. These are kind of the basic aspects of promotion and advertising medical devices that we look at. Premarket notification, premarket approval are the two ways that medical devices get to market. Whether it's the labeling and advertising authority the mda has over medical devices, intended use has to do the kinds of claims that a company makes for the use of its products. All of this touches the practice of medicine, which fda doesn't regulate, and I'm going to touch with our work with the federal trade commission. Premarket notification, these are generally lower-risk devices. Essentially, these are devices that are cleared for marketing based on being equivalent to a part that either is on the or was on the market prior to the date that the medical device amendments were enacted in 1976. For the most part, general controls and special controls apply to these devices and they don't get the same rigorous review that products that require approval do. Company submits a premarket approval application and the product will be approved if the way that the conditions of use are presented in the labeling provide that reasonable assurance that the product, if it's used according to the label, is generally safe and effective. Okay. Central to our regulation of analyze specific free agents and how that affects genetic testing, an approval order granted to a class three device that requires premarket approval. The approval can restrict the sale or the use and distribution of the device. To the same extent that it's permitted by section 520-e of the statute, which basically says that if fda believes it's necessary, they can require that the sale, distribution and use of a device be redistrict -- restricted by regulation so that it's either made into a prescription product or upon any other kinds of conditions that fda thinks are necessary to provide safety and effectiveness. 520-e referred to restricting devices through regulation. There are only three devices currently clear, restricted by regulation. All of the other ones -- any other restricted devices are restricted through its approval order. Those are all of the class three more rigorously reviewed devices. The only three that are restricted by regulation are analyze specific free agents, and hearing aids. Most restricted devices are class three that require premarket approval and are restricted through their approval order. Okay. Section 502-q provides that a restrictive device and restrictive either by regulation or approval order that a restricted device in its branding if the advertising is false or misleading in any particular or used in violation of any regs prescribed under section 520-e, so for analyzed specific free agents restricted by regulation,502-q would be restricted if it's false or misleading or sold in of the restriction captured in the regulations, which I'm going to mention in a minute. Section 502-r is false if it doesn't include the intended use summary of relevant risk information. And device labeling, which is a broad category of material that includes any sort of handout, glossy brochure, any piece of material, essentially that a contribute distributes is labeling. A device is misbrand fd it's labeling or false or md leading in any -- misleading or any particular. That applies to all devices. The advertising limitations that I talked about were for only the restrictive devices but fda has labeling authority over all devices. Labeling, as I said,interpreted broadly. The material doesn't have to be physically with the product to be considered labeling. It can be as long as it is textually related, it's been determined through case law that essentially if it's about the product, it's labeling. Advertising is not really defined in the food, drug and cosmetic act. It's mentioned but it isn't defined. So the center for drug evaluation and research has regulations, and the way that they define advertisements, basically, is, and adds that think about sort of intuitively as an ad in published journal magazines, other periodicals and broadcast ads. Our review of advertising as opposed to labeling brings us closely in to working with the federal trade commission. In 1971, there was a memorandum of understanding between the two agencies that essentially decided that fda would have primary jurisdiction over the advertising of prescription drugs and of restrictive devices. Those devices restricted by approval order or by regulation and over the labeling of all prakts. And the federal trade commission has primary jurisdiction over advertising of other than restricted devices and over-the-counter drugs. One thing that's very important in terms of the genetic testing issue is that fda hasn't really clearly defined the Internet as either labeling or advertising, so while we do apply our jurisdiction, it's not clear for the most part whether we are actually defining it as labeling or advertising. And it's the in general, the substance of the claim that we look at. We did have an Internet working group a number of years ago that was attempting to make that determination. It was, in fact that group was disbanded. The federal trade commission has a broader authority over advertising in general, which is why their role is very important in this area. Okay. Analyze specific reagents used in idt testing are restricted, as I said, by regulation under the authority of 520-e. This is the regulation that I've shown here 809.30, which restricts the sale of sar's. They can be sold to ivd manufacturers, they can be sold to labs granted high complexity determination and then they can be sold to organizations that use the reagents for other than medical diagnostic purposes. The labeling for asr's is limited as well. The labeling has to make clear that analytical and performance experts are not established, and for class two and class three, the higher review amize specific reagent except as a component of a specific test analytical and performance characteristics are not established. The reason that's important is that when the tests are marketed and they are marketed only to labs, they're not allowed to make a claim for the intended use of the asr. Once they do that, it becomes a device subject to the claim becomes subject to fda's jurisdiction. Okay. The advertising, the regs on asr's require that the advertising promotion, which includes their labeling and their advertising include the identity of the analite and again the limitations. For class two and class three, as I said, they are limited to whatever test they have been shown to be used for. Class two and class three are higher risk uses, essentially class two are mostly blood bank kind of analyze and class three are HIV tests and tb test and a number of others. Okay. Ordering -- this is also in the regs. Ordering in-house tests is limited under section 520-e of the act restriction to physicians and other persons authorized by applicable state law to order such tests, unless, as I said it's sold to ivd manufacturers for other than diagnostic purposes. what happens here is that in all of this direct marketing to consumers, the testers used in labs that are developed using the analite specific reagents are technically limited by regulation. No one should be ordering the tests except physicians. You do have the way that a lot of the medical device contact lenses or a lot of prescription drugs, a lot of the web sites that sell those will have a physician on their staff that's perfectly willing to write you a prescription. Whether that's valid, the prescription itself in that setting where you have no relationship with the physician depends mostly on state law. So the state's regulate pharmacy and the boards of medicine. So who can actually prescribe a test is up to the states. But this would be helpful in terms of our regulation of tests used developed by labs using asr's if we knew how to apply this, and if there was support in the agency to enforce it. It's not clear here, actually, who -- whether this would restrict the lab from accepting an order. I mean, the problem here, this doesn't really discuss who comes under the jurisdiction and who would be responsible for basically not ordering in-house tests. So the question where this genetic testing involving laboratory developed testing is really whether the of the asr, which we do regulate and the lab process become a device, you know, conjunction of those two things become a device. That would limit the reordering of those things to physicians fist establishing whether it is a device and then as I said, this issue of Internet prescribers. Limiting access to the tests, even if we could enforce that of the regulation, wouldn't prevent labs from advertising the test, and then the question is, whether advertising a specific use for asr by the lab creates a device that requires premarket approval because generally what starts fda jurisdiction over the product is the claim the company's making for it. So if a lab is establishing a use, then they could misbrand the device if that were an inappropriate claim for the asr. Okay. When we look at enforcement as a whole, and with specific reference to ivd's and tests, we're -- fda is focussing right now on risk-based reviews both in terms of public health priorities and in terms of resources. Here for asr's and laboratory tests, you know, there are a lot offish b shoes about whether the tests are valid, whether they've been shown to provide the information that they really claim to provide, look at the consequences of false negative and false positives. Several viewers talked about the kinds of health care decisions people make or employment decisions or all sorts of thing maz may -- that may result in an incorrect answer. We would at the seriousness of the disease or condition, the role of the genetic counseling and then, you know, the issue about whether genetic information places a certain burden on people that they may not want. All of these things are, you know, broader issues that fda really can't decide itself but that go into our Cal cue louse. The agency has cleared about 12 Nen netic test kits. These last three are among the more recent. Dr. Joe Hackett, who heas here, can speak for peiveg about she's tests if anybody has specific questions. I'm not a sigh enterive. I don't really know what exactly they do. These are some of the kinds of claims that we are worried about, and as Matt said, you know, we need a slam dunk. It's not -- there are a lot of claims out there, but in trying to identify -- here we talked about the impact of wrong information or the seriousness of the disease. We need to put all of those together when we're looking at how to best use resources. So these are the ones that we've identified as Matt said, a chart with a number of Internet companies. These are the kinds of claims that we've sent for now, companies are claiming that their tests can predict how someone will met tab lies drugs or have adverse drug reactses, nutritional counseling, tendencies toward obesity and detecting sus Septemberibility sus Septemberability, auto immune diseases, chronic fatigue and a number of infectious diseases. As we've said, fda and FTC are working now together to coordinate some of the information we've collected. The comftion on the -- the information on the web site. I want to sort of point out right now we're focussed on Internet web sites. There are other kinds of advertising for these products. I haven't actually seen of it, but because the of the Internet has become so widespread and it's national, this is a good place for us to start. Okay. Thank you.
Thank you very much. Why don't you, just because I know we'll have a lot of questions. It will probably be easier to take it from your seat. The other comments that were made by Matt and Maureen as well. So the floor is now open. Let's start with Emily.
Deborah, I had a question for you because I'm concerned that your use of analite specific reagents, which my understanding for that there a very specific claim made by the manufacturer of an asr that is T. is an asr and can be used as a component of a home brewed test. is that most of the labs we're concerned about are not buying analite-specific reagents from a certified manufacturer, they're just going to a regular research supply house and buying a component the components they need. Does that mean the fda really doesn't have any control over what's going on there?
It would be the same type of situation where we're not looking at the laboratory offering of services. Only if they were selling that test to another laboratory. So whether it's an ss -- asr or not, that doesn't make a difference.
So let's just take a concrete example, one of these Internet companies that's offering to test for risk of future development of osteoporosis. They make up everything completely in house, home brew, does that constitute any kind of an asr that fda woulden able to regulate?
Not if they do everything in house.
Okay.
If they buy the Regis outside, then they come under asr concernsp.
So if they buy from xyz house, does that fall under fda?
If the -- the asr would. This is of the problem. of the problem is or mean, whether the combination of an asr that's sold to a lab and what goes on in the lab can be regulated by fda. The other question is whether the home brew, which is where they do everything, whether that can be regulated?
Right. My big concern is that most of these folks, asr's are made in general by legitimate gmp manufacturers who are making them with the knowledge that there is a real medical utility for them. And that the plateses that we're primarily concerned about are doing it totally home brewed. They are not using anything that's any component that's marketed as an asr. So what can we do to control the proliferation of those kind of assets?
That aspect is not my strength, actually. I don't work in the ivd group. I think they are probably in a better position and they can look into that sort of how widespread, you know that is. I don't know enough about
It's very widespread even in clinical laboratories. They are offering legitimate tests. So my guess is it's there in the ones that are not offering legitimate tests as well.
We don't know for sure none of these tests are legit in the, either.
Right. But I mean, with the assumption that some of them might not be, my guess is that they are not getting components from a legitimate ivd manufacturer or gmp manufacturer, I guess. I don't knowp. You know, we can talk about that at fda. We can get but I don't know how else to answer.
That's good. I think if you can look into that, that would be terrific. We've got in the list, Julio, Ed and Deborah. One comment is that this issue of trying to control something seldom works. If there is a need for something, people will jump through whatever hoop to fill that need. There is a need for workers in one area. It can put any type of immigration barrier, people will jump to get the job. The situation the way I see it, the taxpayers pay the tax, the money to the research. The research is done. The results are published in the scientific literature. Stories are reaching the covers of the York Times," anything you open there is something about the yen netic risk for this, for that, for the next thing. Then you go to a doctor or traditional medical institution and try to get a seft test. Even when you can talk about, you know, risk for, you know, impulsivity, which there are genes related to that, but I'm not even talking like that. So let's say in my own area from a genetics, the oldest thing in the world like a field [ ] 50% of the best selling drugs in the country. About just under of the average Caucasian population has a variant of the gene that has no [ ] Another same number 10% have multiple copies of the gene that give the dprug drug that met tab lies very fast. There's no effect. So it is a real concern in the clinic. Some people go to the doctor, they have side effect. After test they have several patients like that. They go to the doctor like in the mayo clinic's beginning to test for that. You go to your average like ivy league medical clinic and say, you know, can I get tested for this in the hospital lab? They say no. You enthusiasm come up with a test people have a hard time finding a doctor who can understand that. So we fund the research, we let it be done. The results are there. Some are them are more controversial. Some are not so controversial. People go to regular health care, you know, system. Nobody uses the test. Nobody can handle it. There is a need. They going to find something. You can put every regulation you want, you can prohibit things from United States, people will send it to Canada. It will be done in Europe, someplace. As long as we say that the issue is important, advertise the results and in the traditional health care system cannot hand tl at all there's going to be a gap and the gam is going to be -- gap is going to be sealed. I'm against people saying send your test here and we'll tell if your son will become a drug addict. I don't think you can make that kind of claim. We should watch for blatantly false claims, which I think you are very correct in trying to do, but this kind of a marginal or questionable predisposition risk, as long as we say that we try to justify the funding that saying that the issue is important and then don't offer people anything, you know? So there is a need, it's going to be soon.
Thank you. Ed?
Yes. One of your comments that the fda is not clearly define the Internet promotion of labeling and advertising was interesting. I thought, is there something that this committee could do, at least in this context, to try and help the decision be made there is of such a big issue that would be spitting in the ocean for to us do anything?
My guess is that it wouldn't be very helpful. I mean, I think that this is something that just has a lot to do with fda's variously evolving thedes about promotion and how to regulate it. And I think it's been an issue for so long, and it is dealt with on a case by case basis a lot of times that you can certainly, you know, comment on it. My guess is that it's not something that is going to get a lot of concrete action.
Well, I think that if we should write to skttry Levitt about direct to consumer marketing and make a recommendation to the secretary that we might wish to include in there this issue that I would certainly. I don't know, maybe there are people on the committee who would not feel that the Internet is a legitimate source of information, but given how often I use it every day, I certainly think it is a la jt mitt -- legitimate source of information. My guess is that it's more powerful than most other media these days for public. So I would hope that we could include at least a sentence or brief pair are a graph saying -- pair are a graph saying that this should not be an impediment to pursuing these companies. One of the things, by the way that I do hope that the people in line, Deborah, hung and James as you start to question but also given that we're getting near the 11:30 hour, I want to make sure you start to do what Ed did is start to formulate what see as being next steps if any. I think Ed is starting to push some of that together. Julio had his comments about what we ought not be doing. Just think of action steps as you ask your questions. Deborah dism. I would like to follow up on Emily's comment because I was taken aback by the inclusion of asr's in the discussion because I see asr's as part of the regularry framework in which laboratories were set up by the fda to allow types of testing in a regulated fashion that are not necessarily able to be brought as pma or 510-k approved full device test kits. And I don't think that's what the committee was asking about or targeting when they were looking at the direct to consumer marketing that was being done. I don't know how they're doing their testing, but I doubt it is using asr's that are manufactured. Well, I think that's -- I mean, I think that's what I would discuss and get back to you about, right.
Hunt? I wanted to raise another area is whether this falls in of the groups or whether this is of the things you should not worry about or worry about in his own time. In addition to direct to consumer marketing for tests for trade predispositions, there's also a growing number of tests that are much more frivolous in their intent. Or they have no intent at all. It's more like sport. So you can, for example, any member of the public can get for $29.95, a little kit, take a swab, send it off and get some genotyping done or sequencing done. Depending on how you read the inserts on these packages, either to be the first in the neighborhood to have a little bit of your genome done which could be cool in some neighborhoods or because it actually is sort of telling you something that might be important in a very vague and unstated way. You can imagine some of these could be for paternity issues, parental issues that come up in some households or markers that are prescribed and could become linked to some trade predisposition. This is widespread. I tripped -- sorry, a family member of mine tripped over the target web site. I don't spend a lot of time there myself. But for $29.95, you can get this. The question is, I guess my concern on why this might not be the best possible testing to be out there is that most members of the public, notwithstanding my desire to have the public think it's cool to have perhaps bits of their genome sequenced, they're not prepared to know how to interpret the information. Either in terms of the genetic makeup of a y chromosome that's floating around the family or in terms of mini satellite repeats or tri-nuclear repeats so they'll read something and then see in the newspaper in which the expansion has been connected to some disease. Who knows who's connecting the dots between those even if that's an unintended consequence. So my question is, is anyone looking at this kind of direct to consumer marketing or is that something we should just let go because there's far bigger fish to fry? My concern is the public education is just not at the level where we're quite ready to have potentially millions of people having a little bit of their genome sequenced or Gino typed and have that information in front of them.
Do you send that tissue to a lab
Yes. You send this swab off somewhere and three to six weeks later, the test result comes back with a suitable for fraisming little certificate that says, you know, this is what you've got.
I'd be continuing our work with FTC trying to find the slam dunk case if that would fit in. I don't think that's a slam dunk for the FTC. you have to decide what's deceptive about it and what the injury is and how serious the injury is. And I think on our scale, you know, case selection cry tier yarks the case where the test purr reportedly determines your susceptiblity of conser would be far higher than that would on the case selection. I'm not going to eliminate it if you want to talk further about it.
I mean, if you want to send the name of it to us, we can look into it and see what it is. I mean, there are products out there that shouldn't be there. I don't know enough about that one to know exactly but I'd be happy to look at it.
Clerveerly marketed tcag, g as in gee whiz.
Thank you. James some.
I want to emphasize that when we're talking about tests, I'm being obtained some way or another, they are fairly restrictive in the expertise or the availability, that's one thing, but I we should also remember that the entire intent of advertising oftentimes is to create a need where there hasn't been a need. While advertisers are certainly able to do that and free to do that, it seems to me that the interest that we have is to make sure that they aren't creating a need that's harmful to people or using blatant misinformation to mislead an uneducated and unsuspecting public. And I think that perhaps with one of the roles of the expertise of this committee can be to try to help find those tips of slam dunk cases that are clearly not supported by science, that could have potential harm to people. As opposed to those types of advertise types of activities that, well, you know, they backed up by good sigh Epps and may not be available. Let me, as we start in the five minutes that remain to try to sort of where we come out on this, first is, I think that the committee has grappled, I think, responsibly with our obligation to the public. We are raising this as an issue of concern. And we have because of our efforts caused the creation of several task forces within government that are looking to how they can do their job appropriately. We don't want to cause problems in what we're trying to do. We're trying to act appropriately, finding the right cases where there really is egregious behavior. Let me ask because of the recommendations I'm going to make is that we respond to the secretary saying that we are gratifyd that there are these committees formed, these interagency activities that are ongoing and that we are they are seeking out appropriate cases for review. And we will say in our letter that we, I'm suggesting, in our letter, we would sort of say that our members are willing to find or recommend jam am -- examples that are of particular concern to us from our experience for the committee's consideration. I wonder or not there is any experience with just the fact that you all have targeted an area, you know, just generically, that you have targeted an area and made it widely known you are looking carefully at bad behavior. Does that in and of itself have a chilling effect on egregious activity? The fact that manufacturers or advertisers know that you are looking to take somebody to the hoop, as it were, basketball playoffs right now. That you are willing to look at it. Does that start to in and of itself have people start to behave a little more responsibly? Do you have any experience in that regard?
The FTC does, but because we're a law enforcement agency, we a very fine line between what's appropriate and what isn't, and we don't want to chill legitimate businesses from doing their jobs so typically, we have a law enforcement matter that we make public same time that we, for example, issue a consumer brochure or alert saying watch out for this kind of advertising because, you know, the only disease that's going to cure is too much money in your wallet or whatever. So, yes, it does have an effect, and for that very reason, we're very caution about doing that.
And
Please finish.
No, that's okay. , no I like what you areGo ahead.
So in some cases, we might issue a brochure, for example, I did in the we hadn't brought a case yet but there was a lot of bad advertising going around, and so we issued a brochure saying go into this with your eyes because there's some problems. Now you still will need reading glasses and there are side effects. We did that and I brought a case later. It's very for the FTC to do that. It's possible that no one other than myself at the federal trade commission has made nigh official statement about our interest in this area. So we have to be very cautious. I really think that's a very balanced and appropriate statement, Matt. Deborah, just real quick in terms of fda. Same thing, I assume? I think with some industries it does. With others it probably doesn't. There are times when we have sent, you know, 30 letters to same kind of industry, and they, some of it, companies that were making SARS claims for masks. There were about 30 letters sent to these web sites. You know, I don't know how many more were outWe get -- we'll take an action against one company and then that company will send a letter about its competitor two weeks letter. So I think it depends, really. I don't think it's consistent. One thing I just want to make do at least, is I think and Matt's point is important. We're not looking, and it's April Po -- apropos, I assume committee is not looking to chill or have a neglect-effect on appropriate behavior. What we're trying to do is make sure that the public is not being preyed upon by inappropriate people who are attempting to do things to them in an area that has special significance. And to the extent that we can make it be known that we're -- that this is being looked at carefully, I think is important. Deb brarks you wanted to make one more comment?
Yeah. Fda in addition to the enforcement actions provides some educational information on the web site. I mean, there's an area for hot topics where it talks about breast cancer, other things. We recently as of a couple of years ago, all of the full-body scans that are being advertised where it's not really thought to be, you know, necessarily safe and effective, the tradeoff in terms of finding things that may be benign or in a sense, you know, there is a parallel with some of these genetic test where's you create a need to go get it by advertising it, and then, you know, should you or should you not use that information. What the fda did, because we didn't generally have -- we had authority over the devices but it wasn't the devices being advertised, the services. So on fda's web site, we put discussion about the ct scans, the body scans. And that might be an approach for the committee to look at in terms of public Ed caights that, you know, fda can't do by itself that would be helpful terms of adding.
Great. Matt? We just wanted to say one more thing and that is that it's possible in this area that what we tip achelely don't do we might in fact want to do, and that is issue some kind of alert general about this area and what's going on for watch out. For example, if we don't find the slam dunk case or even if we do, the issue is brochure before we do. I talk to my folks about that.
Let me do a level process check here. We're three minutes into the time for the next presentation and lunch is right after that. But this is important, so we're going to get two hands up. We've got Ed and Kevin. What's on the table in terms of specific recommendations are, and I will allude from what the group has already said as well. One which is short term and one is longer term. One is a follow up letter back to the secretary saying that we note with interest and approval the committees that are forming, urging them to find, you know, the appropriate cases. Number two, that we ourselves will send to them cases that we are made aware of that we think may be a good example. And then those two are the ones that are at least now on the in the letter. Part of the recommendation is, which we cannot discuss in the time we have here is the idea of public education. We have had that issue on our table before. I think we're getting to the point where we really need to deal with that. We'll probably have to debate that in some length later in the meeting, squeeze in a few minutes to see or not that's appropriate. I just wanted to put it on the table for my own personal interest, which is something we have to talk about. Matt and Deborah both talked about doing something lab ratively with government which gets out useful information for a consumer to use in this area. Ed and Kevin?
you forgot to include the -- defining Internet as advertising and information as advertising in the letter.
Terrific. Good for you. Ed and then
I would argue that we have heard that there could be increased public education, and that we should include that in the letter. We've heard from in testimony before us before about the misleading advertising that's there. We could go back to that to document it. I think we should encourage increased education about this issue. Then the other thing, this is a question to Matt and Deborah. We all work better with deadlines. Would it be helpful to you, also, in the letter to recommend that the task force get back to us by some point in time? Would that help you or would it be damaging?
It would be damaging for me, I'm afraid to say because this is a new area. Although I'm happy to work under deadlines, the folks I'm responsible to don't. , when they haven't gotten the head's up from anybody else yet. So it's not a good thing I don't think.
Would you mind though because of the interest on the committee and even if you have to, you've given yourself a good pass there, but we would like to get an update at the next October meeting way things are?
Absolutely. That would be the way to do it. Kevin, last comment?
Just a quick question on this public education piece. And I'm glad to hear you have the information information on your web site. Has anybody done a check see if you Google or use some other search engine these particular genetic diseases or particular idea about finding genetic genealogies or whatever that your web site comes up in the search engines -- engines or can we look to see what possibilities there might be in cooperation with the search engines to make sure that these web sites come up because the information is there, and I think it should be getting to the public.
I can check into that with our I. T. I know fda's web site gets a lot of hits so the public is aware of it, and that it has information. But on that specific issue, I can find out.
Matthew and Deborah, I want to really, really thank you. You've done your jobs very well. Naw Maureen, thank you very much, also. This interconnection. I feel like for the committee's sang, whether or not somebody wants to write that we're moving at a glacial pace, because of what we've done, we've caused people to move in this issue and it is clearly in the minds of agencies that have extraordinary clout and also, though have a responsibility to proceed appropriately and carefully and cautiously so that they do no harm. I think that's what we're hearing here. So I think this is a good outcome. I think we are moving forward and clearly you can expect that we'll ask you back for our meeting. We've got a few recommendations, which we'll summarize at the end of the day to move forward. With that, from a process check, announce that we'll be five minutes over 12:00 for lunch, so I'm sorry?
Just one more thing on that. Considering the rapid decrease in the size of glaishses around the world, I took it as actually a compliment. [
A true scientist thinking about things. We're going to be five minutes over 12:00 for lunch. We'll build that in. We'll get a update on SACGHS's focus on the work on the large pop studies. I want the committee to again remain focussed on what do you see as being the recommendations, the action steps that we want to recommend back to our subcommittee at the end of this half hour? So really be thinking about what you want to charge your subcommittee to do. that, the chairman of the subcommittee, Tom Willard.
Thank you, Reid. I thought the best way to begin would be to do a little bit of a review of how this task force is formed and how would the committee decide to take on this issue in part of review for all of us and in part an introduction for our new members so that you are more up to speed on this issue and can help us decide where we want to go from here. The issue of studying large populations came up in deliberations by the committee as we began to prioritize the kind of topics that we would tackle soon after we took office I was going to say, informed our committee in June a couple years ago. For the purpose of deaf nation, large -- definition, large population studies are considered to be longitudenal studies of a large and usually diverse cohort of subjects with a purpose of elucidating the influence of genetic variation as well as environmental factors on complex diseases and/or other traits. Occasionally in some countries, these are referred to as buy yo banks but for our purposes we're treating those as the same. A number of large population studies are already underway in countries around the world and there's interest in this country in a number of quarters to discuss the need for and potential value of large population studies. Planning is already underway for a national children's study that'll focus on studying the influence of environmental exposures on childhood disease and development and the va has also been examining or considering a project in clinical jean momentic -- genomic medicine. Shortly after we listed large population studies as one of the 12 priority items the committee wanted to focus on, we formd a task in the fall of 2004, a task force existing of not only myself but Joan Reid, Kevin Fitzgerald, Debra Leonard three of our ex fish yos rkz Ellen fox from the va, and Maureen quarry from cdc. That task force was charged with designing a session at a meeting that was held in march of this year where the task force decided the best way to spend time at that meeting was to review not only some of the scientific issues that were play for the benefit of educating our committee but also to focus on the social policy and legal issues that were either of concern or that we would want to touch base on in deciding how those activities might go forward. And we received an update as well on federal programmatic activities exploring the kinds of studies that might be undertaken by one or more of the federal agencies. After that session, the task force was charged again with deciding what to do and what to potentially put into a letter or recommendation to the secretary. The task force had a conference call shortly after that meeting in April of this year, and the sense of that call was that there was still a large number of questions that various members of the task force still wanted to explore or gain some traction on. What was the potential predicted scientific payoff of a study like this? Were there various methodologies that might be needed to carry out those studies? Does we have those in hand and were there identifiable gaps in terms of developing those methods? What kinds of results might result from such study? What would they mean and how would we, meaning society, act upon that kind of information? And how could such a study be carried out in a way that was fair and equitable to all of the different populations and communities that might be involved without increasing health disparities which in principal would be one of the issues trying to reduce. What also came up in that task force phone conversation was that both from our own perspective and by reflecting on some of the international experiences with other large population studies was that we would need to proceed with careful deliberation and in particular, with extensive public consultation. Both to educate the public and to get their engagement in this kind of a project, what it would entail, what would be involved and what the potential benefits as well as the potential anxiety provoking aspects of such a study might be. same time, it was clear to some members of the task force that also should touch base with a broader scientific community in order to get their engagement or find out if there might be concerns in the broad scientific community either about the potential scientific payoff from such a study and/or the cost and processes that might be involved in carrying out such a study. So in the end, we decided to propose back to this full committee that a letter to the secretary endorsing the need for a large population study was probably premature and should be deferred until we could gather additional information about views from the public at large, from the scientific community about such a study and its ethical, legal and social implications. Most recently, there's been one other notable development just this week on June 9th, nhgri posted a report of a group of experts that several of the NIH institutes but commissioned to examine the scientific found ailtions and logistical issues of how one might mount the study in the United States. This is a report Allen Gutmacher referred to in the March meeting of this year and it finally has been posted. I should say as that friewp of experts that work diligently and scamping those scientific and logistical issues, Chris hook worked on that task force and to our own task force to keepous prized of what was going on. So one approach give than that report has just come out and that probably very few of us have looked at it in any depth even though you have a copy in front of you at your places and you should hope the full committee will in time take a careful look at that. I'd like one approach would be that the task force in particular have an opportunity to review the report and some detail and determine the extent to which and whether it's toughly addresses at least the scientific and logistical questions we raised during our telephone conference. If it does, of course we might consider that that part of o are job has been well handled and those questions well addressed. same time, the task force might, though, and this is where we need input from the full committee, might wish to identify the salient remaining issues where we need further examination and further development framing the kinds of in particular policy questions and process questions about how such a study might be carried out, what gaps are there with respect particularly to public consultation and broad scientific consultation, not from the standpoint of figuring out the scientific basis for such a study because that is in in the report in front of you. But the question of whether there is broad buy-in from the scientific community at large around this question. We've also received some guidance from Dr. Zahoney's office in his role of being responsible, his office is responsible for the management of this advisory committee and he's the one who transmits our recommendations to the secretary. And he would certainly like us to provide advice on the in particular on the prots sess and pathways that NIH or hhs itself might use in reaching an optimal decision about taking such a study. I interpret that to mean -- we should focus not on the issues of the scientific merits or the scientific topics that such a large might tackle but rather, again, these questions or processes and pathways what are the gaps, who enthusiasm be brought into the decisionmaking process and how do we identify the types of questions that need to be addressed rather than us specifically trying to answer those questions, simply provide guidance as a committee as we try to identify what those areas are of some concern. So that's where the task force stands at the moment, and I think for the remaining time this morning, that we should open it up to a full discussion on the order to get full input from the other members of the committee, including our new members, and to get specific guidance back to the task force so that we know what prob jobs we're supposed to do two days from now in order to continue examining this important issue.
As we go around the room, and I see Francis' hands and a Faw others, let me again focus, what you are trying to do in your questions and your guidance is to help the committee grapple with our role of do we and how do we help give guidance of the idea of the process of going forward with this study? Do we, and as my notes as I look at my notes, again, do we look at buy-in, and how do you achieve buy-in do we have a role in helping to achieve buy-in by the scientific community, public perceptions and perspectives on this matter? Other issues that have to with the process of getting this done. What we are saying is that we do not see, at in the subcommittee a responsibility that we have to get into the scientific issues involved but more of these other sorts of issues. With that, let me start with Francis. I appreciate hunt's summary task force is doing and Reid's exhortation that followed. I hope the committee will things are allowing it in terms of your time, take a close look at this report of this expert panel representing the work of more than 60 people who worked quite intense ofly last year and considering the design considerations that would be important to think about if we were going to mount a study of this sort in the United States. There's a great deal of detail in there about power calculations and what kinds of expectations you have about how the study design might be carried out. What would go into the clinical and laboratory component, what kind of technology would be needed in order to add vns our ability to collect information about environmental exposures, ambulatory, physiology, diet Terry intake and so on. We would be very interested in thoughts task force and the committee about the way in qh these recommendations are phrased. But I do think, again, picking up on what hunt and Reid have said, SACGHS could play a useful role particularly in this area of trying to seek public input about the wisdom of such an undertaking. When this was undertaken in the uk, for instance, there's what a good deal of public consultation, and heard about that at the last meeting. That's obviously critical for anything of this magnitude, which will require not only grudging assent but I think enthusiastic embrace by the general public if we're going to undertake a project of considerable magnitude that has long consequences for our understanding of health issues. Given SACGHS's visibility and your connection to the secretary, it seems to me that this might provide a useful venue for that kind of a discussion, and if I could be so bold to even suggest in the October meeting you organize the session to receive public input about the wisdom of such a study. That could be very helpful in considering the next steps in getting this underway or not, on a whole variety of factors. I think if we went much farther without soliciting that kind of broad public input from advocate frdz a variety of different populations that have had differentes with medical research, then we really potentially could be accused of just riding over those concerns without lisping -- listening.
Francis, that is a concrete tangible suggestion. would you feel about addition to the public perceptions but also if we were to bring in representatives from "scientific community," also. that be a friendly amendment to your It would, indeed.
Thank you very much, Francis. Ed has his hand up. I was going to actually my hand was up before Francis talk about the public input. That's what I was going to suggest. I would look to the model from SACGHS maybe even think about it as more than a half day session. The thing we did at the uft of Maryland, which really was what begin to open my eye goods the genetic discrimination issue at that meeting. So I don't know if logistically that would be possible to do, but think about at least maybe a full day's session and whether it was connected or disconnected to this meeting, the meeting of the committee. But look back to that model.
Great. Thank you, Ed. Agnes? I also agree with the recommendations that have been made by Dr. Collins and Ed. I think that besides the scientific and public input that could be garnered from a public hearing like this to also consider having people from the ethical bath round since that is one the things that we've been commissioned to look at the impact on the legal, social and ethical issues.
And also perhaps companies because there are companies that are in essence doing large population studies add part of the snip studies and a of the drug companies are doing this now, so I would look at when's already being done in the private sector as well.
Very good. Other questions or suggestions? Yes, Deborah? What would be the mechanism for soliciting this kind of input? I'm not familiar with how SACGHS did this prots ses but would it be in a federal notice that won't get the people that you really want to have come make comment. What are the mechanisms for doing this, and do we have the ability to use this report in some truncated format? I think it's a terrific question. I think maybe first of all, I am glad you raised it in this meeting. Maybe the type of question we'll leave the task force to grapple with but there are a few general comments a nt to give to the task task force to consider. Ed?
When we did that public comment with sacgt prow proceeding that meeting, we used an E-mail network and also posted on our web site that we were interested in feedback from the public. a bit of comment. I think if I understand Deborah's point, and let me try to read into it is that on the one hand, I think first of all I think it's important to cast a wide net because we always want to get opinions from people with whom we may not be familiar. I think Deborah may also, though, be saying that we also want to in specifically invite some folks who are known to be thoughtful in these areas who represent the community, and so maybe it's a mix of both. Am I reading you right?
Right. And there are issues like if hold meeting in Washington, you'll get certain responders where if you hold it in St. Louis you'll or Minnesota or Texas or California, you might have other responders. I don't know how you get the -- this is a U.S.-wide initiative. And I remember from the uk discussions of their buy yo bank, their discussions were town hall meetings very widely distributed. I don't know that sacghs can do that kind of initiative. I'm concernd that we may think we're allowing a venue for a public dialogue when we're really not.
It's a good thing for the to have to grapple with for the subcommittee. A couple, Francis, Ed and Emily, you are on a different topic, I think, right?
No, I'm not.
Just a quick response to the concern about how to do this so you hear from all parties. I would make it clear, I think, that this would not be the only venue for soliciting public opinion on something as important as this. If you look at what's in the report, there is a recommendation about having surveys, about having focus groups and having town meetings. Obviously if SACGHS wanted to go on the for a few week asnd meet all over the country, that would be fabulous but I have a feelingat's not quite what you think you signed up for. So this would be a component.
Ed?
For that meeting we had that I'm referring to the university of Maryland, we did get people from all over the country. I remember one woman from Hawaii. It was through thet working with consumer groups were able to identify. Also, the purpose E-mail or the web site was that we got individuals who told us what they felt about this think, you know, to us it all makes sense why we need this, but when Linda McCabe and I just finished a course for the spring quarter where this came up in the course with some undergraduate students, and they were -- half the lass or more was very fearful of this when it fist came up. So I think it is very important. Also, look thet the of the public are and then some public education about why this is so important.
Terrific. Emily?
Yes. I just wanted to make a couple comments. One is I think Kathy Hudson had a good model that she used when she took some things around to town hall meetings. I'm sure you are aware of that. I would encourage you to do that kind of broad geographic and social economic outreach kind of effort in discussing how this kind of a study should be done. The other comment I have is that although I think our committee could certainly serve as an adjunct to that, we shouldn't get involved in thinking that it's only our role to do that, you know that we can be one of many public forums, but as you said, I don't think we can take the group on the road for, you know, annex road trip city to city, but I think that's the kind of outreach that it's going to take to really pull out the varying levels comment that you need and that there to be some active outreach to groups who aren't going to see things in the federal register who aren't going to come on a SACGHS web site. So there has to be some sort of proactive outreach. All right. Hunt? I want to raise a question for the committee members specifically because I do think we need some feedback on this. The question is, so I hear some broad support for organizing a session at the October meeting as the perhaps the first but by no means the last of the kinds of efforts that would be needed to do this, however, I think we need to examine as a committee whether the recommended course of action would be that the NIH itself lead the charge for the majority of these kinds of public town meetings and sessions around the country or whether, because there's a perceived and/or real vested interest that the NIH has in seeing this approved and going forward, whether, in fact there is an ongoing role for this committee as an advisory committee with public representation for the secretary that that provides a greater level of little bit of an arm's length view on working with the public to see what the public's feelings was rather than having this fall back on the expert panel or on nihgri or the NIH. I think it would be useful to the task force because we can examine this to get a little bit of feedback on the committee members at large for that question. The question is there. Guidance? Yes?
Well, I would agree with you. I think the NIH will probably have a role in doing this, but I think we should or you all should continue to look at this issue. I think we can be a public forum, and we can even be a broader public forum than we are in this room. I would look to how we could -- embrace the public more about this issue.
Francis.
I would say NIH would welcome that. I should also point out this is not just an discussion. The cdc's been involved in planning process, epa as well. Certainly, if NIH was going to be aassistance in mounting this kind of public consultation, we want lots of advice and want to do it by a contract through an outside organization again to keep this sort of arm's length relationship. The worst thing can you do is to set it up so it looks like to has a guaranteed outcome and nobody believes it anyway. We wouldn't want to make that smstake.
Deborah? I think read this, we theed to keep in mind our overarching outreach and how that's addressed in this document. And then two more structural things. I think many of the task force members are rotating off the committee so do we need to re-look at the members of the task force and do we need -- well, will Chris Hook remain as the representative or does this report mean it's over? As we start to think about and summarizing this discussion and keeping to our time limit, I just want to make sure, and I know that a lot of -- Allot ta Skurbaugh is here, and I'm not asking to put her on the spot but I wanted to give you the opportunity if there is anything that you either would like to say regarding Dr. N.'s perspective on this and/or any of the time line relevance in terms of our talking about doing something at the October meeting, or not that is a realistic or legitimate contribution given the time lines that the director's office may be on, I just wanted to give you the chance to comment if you felt inclined to do so. If not, you can just sort of wave me off. Even if you are not going to say you are not going say anything, you have to use the mike. I think the committee got Dr. Zahoney's wishes just right, and clearly Dr. Collins' responsive to where the committee wants to go here. It was important to point out that Elliott's point in tasking the committee was to look at not only the public consultation that you all might do, but to also make recommend daiptions about the pathways and processes, meaning other consultations we might engage in that you can't design yourself but what you might recommend it to NIH as part of Francis' and NIH community along with the department epa, and outside the department might consult. There's two levels here what consultation you do and recommendations about what other pathways and processes you feel the government should engage in as it makes an optimal decision about whether to proceed if so, how to proceed.
Well, the fact that you are here and paying attention to this, I think, gives some of the interest that the director has in this matter. Not implying endorsement of any particular course of action but certainly it is clear that this must be important to send so notable a person as Lana to be here with us today. Thank you.
And I didn't pay anything for that. Thank you.
Let's summarize what I think we have heard. And Hunt will be the first one to tell me where I think I've got this wrong. The proposal on the table for the committee is that we recommend to the subcommittee on large population studies that they plan for a meeting that will be -- which they'll plan for a meeting, which we hope will be in conjunction with our October meeting, but they may decide after they look at it, that it can't be done for whatever logistics reasons, but they would plan on a meeting, hopefully in some juxtaposition to our next meeting in October as a time line sort of guidance that would solicit public comment and comment from the "scientific" community to include, also, some perspectives from Ephesus that would be focussed on getting guidance and advice about proceeding or elements of issues to consider in proceeding forward with a large population stawd study. The mechanism and logistics for how long such a meeting should occur, whether it's an hour, a day or half day, whether it ought to be here in Washington or someplace else, we leave for the subcommittee to wrestle with and grapple with. We have been given models and examples of how the predecessor imht did it in the past, the Kathy Hudson model has come up. We got examples for the committee to look at of ways of doing that. I think that's pretty much what we have tasked the committee to do and to work on. Am I missing anything in this summary of what we are giving them to do? Deborah's say -- oh, and okay, I'll come back to that. That's good. And Deb before's talking about do we have enough on the task force anymore. That is a technical issue. I don't want to put that as part of the proposal for the guidance for the committee. Am I missing anything in terms of guidance to the committee?
Also, I think you want the task force to consider what other consultations should be carried out by others possibly. Were you getting to that? I think what this is that the framework for the work, the guidance to the imht. -- committee. I've given the guidance to the committee summary. The context is that the committee will enjoy the input from Francis' team and those who are responsible for trying to look at whether there will be any other public education activities out there and anybody else that's doing stuff in government. I think that the context is we recognize, I guess, I should make it a preamble to this recommendation is that we our committee is not the be all and end all on gaining these inputs. We are providing an input into the process. We are not the only input into the process. We can't assume that our activity is the complete record of public and scientific input into this prots ses. We are providing an important and significant input but not the only. Therefore, you may be guided by what you do by other activities that may or may not be going on simultaneously in government, but we're not -- that's the preamble to the recommendation. Let me with the preamble and that charge and see who wants to challenge that as a focus?
That's a lot for the task force to do, but should we also look at the public education aspects that are needed? That was also brought up during the discussions. It would be my recommendation that the public education around this would come from understanding and listening to the public concerns, so you of have form follow function if that would be a friendly amendment to yours. All right. I'm looking for some committee member that doesn't agree with that this is what thesomery of the discussion. Given this was thesomery, let me ask for the the task force before we ask for a vote, do you feel this gives you enough specificity to do your work?
Yes. With that, those who are new are apparently not allowed to vote, but we love you anyway. Those who can vote need to decide. All in favor of the motion by raising hands. Anyone who is againstDone. Thank you very much. Task force, good luck. We see this as being important. Glad I'm not on it. It's a lot of work. We're going to have lunch, but before you go to lunch Before you do that, do we wish to ask for a volunteer? We're lowing two of our members. Oh, yes. It would be terrific if one or more of the new members in particular would wish to join us, especially those from -- who represent the public on this committee representing the public on the task force would be ter terrific. That's what a good arm twisting.
Yes, I would participate. That's one. There we go. Look how that works. Hunt, you are a master. Let me tell you about lunch. Committee members and ex-owe fish yos, the lunches you ordered at 9:00, I hope will be brought here so that you can actually mill about in this room and eat. For members of the public, lunch is available in the hotel restaurant as well as from a variety of local restaurant establishments. Many of whom I understand are in walking distance. We will reconvene at 12:00, but because -- no, no, no 1:00.
1:00. I'm from Minneapolis. But let me be fair. For the public, and the people that don't get to get their lunch right here, because you all have to go out and you need an hour at least, I'm going to be fair and cut you five minutes' slack because I don't want you mad at me when I come back out there. So 1:05, but y'all know I'm starting at 1:05. You know that. See you at 1:05. [ Break taken for lunch
We will next here, Sharon Terry from the coalition for genetic fairness
The alliance has over 600 organizational members, largely genetic disease organizations and community-based organizations that are underserved. The coalition is apposed of net tech alliance and over 100 corporations committed to the nondiscrimination legislation. This coalition includes an executive committee comprised of nonprofit consumer organizations, industry partnerships and health professionals, societies and is guided by the society of human genetics. Brian Monroe of millennium, the national society of counselors. The national work rights foundation and myself. We're at your service. We invite your comments and questions and welcoming departing committee members to our effort. The coalition has been advocating for t earlier today you heard all the major argues supports genetic information. You saw a video, a powerful testimony of some of our fellow Americans whose lives have been impacted. I'm not going to rehash the major points today. Instead, I'm going to ask you as committee advising the secretary to continue to articulate the urgency. Americans need to be protected from discrimination, and insurance and they need the protection now. The senate unanimously passed legislation. The president issued a statement again this year in favor of this legislation. However, this year the house of representatives embodied in the past has not been able to move this. That our coalition has been and is currently working with the house, particularly with congress woman bigert and her staff is evident of this fact. The major opposition to this legislation is the business community, particularly the of Commerce and the national association of manufacturers. We do not believe the house and congress as a whole will allow business groups to override the individuals, to make use of genetic tests. Additionally, we do not believe this congress would seize this opportunity to leverage the amazing investments that they've made in the human genome as raw material to be developed into tools that should be integrated into medicine today. However, now research has been impacted. It has experienced a significant chill, in my mind a deep freeze from fear of genetic discrimination. Individuals shy away from research because of the fear of discrimination. It is we, those who are impacts by genetics that have to take up this gauntlet and are working to prove that this legislation will not hurt employers. The coalition for genetic fairness is working hard to rally republicans in all states. We continue to mobilize hour grass root members, over million of them encouraging them to with the congressal members. We have met multiple times with the business community that oversee the business community to limit liability and make them more comfortable with this legislation. At the end of the day we believe congress will make the right choice making it possible for individuals to use their disblet tick information for the purposes, for health purposes. None of us have over our gender, ancestry, disabilities or genetic makeup. However, as a nation we have a choice on how we treat the information. Support for the legislation is support for improved healthcare for all Americans. We are confident that congress will make the right choice. Finally, we would like to thank the committee for all your work. We ask you to make sure the secretary and all relevant parties receive the information you have compiled along with your care testimony and insightful analysis much the millions of individuals who carry genetic mutations they did not choose are asking to us do what is necessary to alleviate the burden of discrimination and fear of discrimination on our nation. Thank you
Thank you. I see you provokeed a couple questions. Let's start with Ed.
Thank you. I'm sure you're already dog this but in terms of trying to enlist other republican members, I'm sure you're using the members of the alliance to go out and bang on some doors
Yes. We've used the members of the alliance well as the by and industry been involved. They've gone to their republican members. We focused on republicans who last year decide cosign. As Jamie said, it's a combination of some people not having us on the radar screen as well as the came ber has raised more red flags and made this difficult for some republicans to sign on.
Yes?
In follow-up, have you -- do you have anyone in any of your groups who have an afillation with the chamber in small businesses, that have been impacted by genetic discrimination or manufacturer groups.
we do. They have been less inclined to comment. They say if the chamber and familiarle back off we'll be more focal. They will back off and be less vocal if the groups come forward. So the companies have lots of employees and are major employers, them joining would give the right signal to those trade associations.
Thank you
Mine is just a comment, actually, to commend you and thank you for all the work you're doing with the coalition for genetic fairness. The task force on the legislation has really been well aware of the work that you have been doing. We feel we have a wonderful partner in the trenches. Thank you
We're happy you see this as a serious issue. Thank you.
Thank you again very much. All right. Now we're going to move into an important section of the meeting the rest of today until 5:00 with a break for a very wonderful awards ceremony. Some people seem eager to leave us so they clan get more involve -- so they can get more involved in activities. As I noted earlier, we determined last that the coverage of reimbursement tests and services was a high priority. We started working on it in our March 2004 meeting. We gathered information from the experts on public and private coverage payment policies and jee he net test providers. We appoint add task force to investigate and discussed the finer points of our recommendations. After the last meeting we solicited public what we consider our really ultimate draft or report. Cindy berry, who has been just terrific leading our task force on this issue will provide us with summary feedback. You have a come pinion and summary in tab four. I want to tell you that the task force members have really done a terrific job and have worked hard. I also want to acknowledge Susan Goodwin who has been nothing short of terrific in providing support to the committee. Let me just say as I alluded to at the beginning of the meeting, we really worked hard at the February March meeting to get that -- some decisions made, and we made some decisions. Now that meeting was challenging, not only for the complexity of the decisions but also we had a lot of people moving in and out, people here, not here. It was really hard work. I think that the committee owes it to itself today to be fairly disciplined about how it approaches this. Emily -- I mean Cynthia and Susan have worked real hard to give a fundamental sfown dation of -- foundation of sort of the recommendations how we got here, what the decision points are and were that sort of led us to where we are. Then by the way, this is the 18th time we've gotten feedback. We've been getting public feedback and rewriting this thing. I want to tell you, it's been seen by so many people. The point I'm getting at is, I hope that we'll listen carefully to the public comments and our comments and see if they -- how they fit in to the decision point, not starting us all back over again from ground zero. It's how do specific comments fit into yes, no, decisions. Let's just stay focused on the task at hand as opposed to going all over God's green earth again. So I give you that in my role as being the bad guy and now over to the good guy. So Cindy berry, take us away
He's got a little buzzer in there so if any of us gets out of line, we get shocked with some juice. I also wanted and the seen the report and seen the different iterations. How difficult it was to not only write the report but to synthesize, analyze and incorporate it into the report, organize them. It was a lot of difficult work and I certainly was not responsible for that, so I wanted to mention that. This afternoon this small presentation, which is impressive to our discussion and our rolling up of hour sleeves to finalize the report will provide an overview of the report, will go over the public comments on the draft report. The third part is where we do the hard work, where we actually finalize the recommendations. As you will recall, the report had several objectives. We identified a problem in the committee based on testimony that we've heard and other evidence that we gathered that coverage and reimbursement of genetic tests and services was a problem. a result, access was limited and we needed to do something about that, so the purpose of the report was to describe the current state of play. What is going on in terms of coverage and reimbursement of genetic tests and services. What's covered, what's not covered. The second purpose of the report is to offer recommendations to the secretary on what we can do to fix some of the barriers that we identified. The ultimate objective is to improve access and appropriate utilization of genetic tests and services. We came up with, as you will recall from our last meeting, nine recommendations. The report goes into great detail as I mentioned the current state of play and all the different elements of our healthcare system and peppered throughout the are these nine recommendations. This is a quick overview the new members. We did receive formal presentations from experts in March of last year. We had several drafts of the report that we were reviewing that we wrote and rewrote and considered. We put out a request for public comment formally in the spring of this year. We held a conference call within our task force to consider the public comments and determine what could be incorporated the report, what revisions were necessary. Now we're in the phase where we are reviewing at the full committee level the public comments and trying to finalize the recommendations. We hope to have another iteration of the report, a final version of the report sometime this summer and transmitted to the secretary in the fall of this year. Briefly I will describe the pub lent comment process. There was a notice that was soliciting public comment. This comment was received -- the deadline was may 6 of this year. had other outreach mechanisms. We have a website of course, the federal register notice. We have a distribution list which reaches approximately over 900, almost 1,000 individuals through notices. We solicited comments from individuals and organizations. Then we did a targeted mailing to 34 individuals and organizations that we thought had particular expertise and that could help inform us on key issues that should be considered in the report. We receive add total of 86 separate comments, 61 individuals commented and 25 organizations. There's a pretty broad base of stakeholders represented. We have health providers, including physicians, genetic counselors, hospitals, nurses, health plans, academia, patients of course. We even had students commenting. There was a school -- let's see west field state college in Massachusetts. They deserve special recognition for their public participation and exercising their significant -- their civic duty. It was a final exam. Their profession of human genetics asked them to submit public comments and they did. We, of course, read all of them, considered all of them. Actually, I shouldn't say we were surprised but some may have been surprised at how thoughtful they were and insight until. We thank them. As I mentioned earlier we had a conference call of the task force where we reviewed the public comments. Everybody has a copy of it. There was chart that was also prepared for us so organize the comments. them terms of they were and what they were addressing. Then we he considered modifications to our recommendations based on the public comments. We did this at task force level. As you can imagine when you have 86 different comments from different organizations and individuals, it's difficult to weed through of those at the full committee level. We don't intend to go through them now one by one. We waded through all of t then what we are presenting to the full committee are the recommendations, are the public comments that address specifically the nine recommendations that are in our report. We're not going to go over today all of the other comments that dealt with language change in the body of the report and some technical changes. We are incorporating those. They will be reflected in the new draft. What we're focused on this afternoon are the comments that specifically address the nine recommendations, and I also want to make a point that just because you don't hear if in the audience or who's listening doesn't hear their particular comment addressed, it's not that because it was not reviewed or not considered or not incorporated. What we're focusing now are the areas where we made a very specific change to the recommendation or is may be an area of controversy, or it may be an area that needs fuller committee debate and consideration. So we rest assured we considered all of them. We've read all of them and are incorporating as many as we can. Today we'll ab little more focused and precise. As I mentioned, we had a list. Is in the binder or sort of the chart that catalogs all the different comments? It's in the binder. You'll find it there. These tables and the charts that are in your briefing book. They have a list of the modifications. You have copies of the public comments. If you want to review the full list of comments we can do that now. You can refer to your chart as a way of organizing your thoughts. We can talk a little bit about some of the things we saw in the public comments presented. In general, folks were positive about the draft recommendation. They thought we were addressing something very important. They, in general, agreed with hour committee's approach to addressing them. There were some concerns expressed about how we characterize the extent of the access barriers. Some organizations felt we may have been overstating it a little bit. Some individuals and organizations have proffered different approaches for refining the recommendations and then, as I mentioned, are others who provided more technical points and comments with regard to the language in the body of the report. Carrying on the discussion of themes from the public comments, comments read was the antidotes between inadequate coverage, reimbursement. We have a quote here where one of the commenters said my Medicaid patients cannot get the assessments since they are unable to recover the remainder of the costs out of pocket. That's an example. The second bullet goes to the comments that we received having to do with the problems results from inadequate reimbursement and billing mechanisms for nonphysician counselling providers. We received there is, concerns about out of pocket payments by patients, reluctance refer patients, salary issues and I can read to you some examples of some of the comments we received there. One said I cannot bill to my oncologist. I cannot bill Medicare and most private and hmo cares. Patients must pay for my services out of pocket without hope of reimbursement. Someone commented many institutions are unwilling to hire these professionals because there's no reimbursement for their services. Many of the commenters encouraged us to specifically recognize abgc and gmcc. The American board of genetic counselling in hour recommendation regarding direct billing. Another comment, series of comments had to do with considering the impact of recommendations on health care the the healthcare sure we keep in mind that any recommendations we put forward for coverage and reimbursement consider the fact that we do have finite resources in this country and that we need to be cautious has we move forward. That last bullet characterizes the nature of those types of comments. Now we'll go through specific public comments on the recommendations and how our task force proposed addressing them, and we'll go through each one making sure that have the input from everyone on the committee and that we further refine our suggestions and recommendations. We'll get this up on the screen.
By the way, again, for the new folks, the other thing to cheap in mind, which is one of the real struggles, because it's a lot of we all want to do a lot of things to change the world we got to keep remembering these are recommendations being set that the secretary of let can do. We are an advisory committee the secretary of health. This is one of the other issues we have to stay focused on. Stay within the realm of what's possible given our authority an and-- and mandate. That's the key
If you want to follow low along. I had it on the top of my chair. The first packet is the slide. Belined that is a documenten titled coverage of reimbursement, follow along with that document because that document contains the recommendations. It contains the edited changes that the task force has made, and then below that it highlights some of the public comments, what we received, what we decided to accept and the changes that we made. That will help facilitate the discussion. The first recommendation pertains to the secretary tasking a group or body to develop a set of principles to guide coverage decision making for genetic tests. We made a few changes there, some comments we received saying the second sentence of the recommendation that was originally in there. You can see the blue line edit. People had some heart burn about that. They felt that was either inappropriate or could cause some trouble. So we had some folks suggest that we had to take that sentence out. We didn't need it since the of the recommendation adequately addressed the problems that we were focused on. Another comment that we had, folks were concerned the wording therapeutic versus informational benefits and suggested instead some alternative language and we tried to address that comment there. So you will see the two changes in blue in your document. We eliminated the second sentence of the original recommendation, and then addressed the issue of therapeutic and informational benefits. don't know, Reed, if you want me to read the full text or just give everyone an opportunity review this themselves and then solicit comments from the group
I think just giving them a couple quick minutes, I guess discussion is always best by knowing what we're talking about. I'll give you a couple minutes like study hall but a couple quick minutes, then go for it. Debra?
Can we just take out and in front of informational utility because we have those two thinks linked. Seems like there's an extra and. We're making a list of items. This would be in the second sentence, prevention, rare disease terveghts informational utility and therapeutic benefit. We don't need to link informational utility and therapeutic benefit. They are two separate items.
anyone else with a comment? Suggested changes?
I disagreed with what Debra suggested. I think they were intended to be two separate things.
This is just a question. As we're looking in the recommendation to establish particular criteria to guide this decision making for appropriate genetic tests I wondered what sort of bridging work we could do with the work that was described this morning. I knee was on the direct consumer marketing but looking at some of the outcomes of the specific genetic test and this might be extremely helpful to establish some of these criteria that there may be bridging work that could be done between that committee and these criteria
Do you reference the trick or are you talking about something else
You're describing establishing criteria that was describe clinical validity and clinical utility. When we get into the area of clinical utility, we're starting to address clinical outcomes. It started this morning that these were some of the measures that they would be looking at and if there was overlap that maybe this committee could help died some of the criteria
I was going to give the committee a more detailed report, but I was describing activities in relation to measuring outcomes in consumer campaigns, both on terms of people's knowledge, attitude and behaviors. As part of the egap discussions which I'll present tomorrow -- I mean, the purpose of such a group is -- one of the purposes is to review what we know and don't November and identify the gaps where more data has to be collected. That probably update each other in the long term. I don't see anything you need to change with respect to the paragraph. You need to watch and see. What you're saying, this is an example of the activities. You can make strong recommendations in the future
Any other comments?
It ensures both public as well as private do not take cost effectiveness into consideration. I'm not saying it should be removed, but it should address, and for those insurers which do not look at cost, that might cause a problem.
disco you think the wording is broad enough that it would enable this group whatever form it takes to look at it and then determine well, perhaps that's not an appropriate factor to include in guidelines? Or do you think it's problem mat tick to be in there
I think the word should, you may want to alter it and say could consider, but should implies that something should be done
Could address
I think we have the words poor example right in front of that list. I think the intention was you didn't -- you should address this list of things as appropriate or maybe you want to add something, but I think the intention we were saying by putting
How about should consider. Does that soften it? They should consider these things and however they come out on that is their decision?
You could use the words may include, for example, rather than should address. This may include
May include
I think this is getting to be word snipping. Should address covers all the other entities we just covered. It doesn't say which side of the line you have to come down on. This just says you should address it. I would urge to leave it as is
I think we're in agreement. With that one, the question, madam chairperson, is it time to call a vote on this issue or do you want to lump them together issue by issue?
Want to go recommendation by recommendation?
I think so
Any other change? Nothing else changed. Let me give everyone a chance to scan the rest of the recommendation. This is the only change. So take a look at the rest of the recommendation.
I was going to move approval
Should address or may include?
May include
May include. To what? We're approving should address and the legislative intent of this is transparent and clear. We all know what we mean by it, so we're there. Should address. All right. We have a motion to approve this recommendation. I'm looking for a second.
second
Good. By show of hands again knowing that our new colleagues are not in a position to vote today but for all those who can vote please raise your hands yes. Those who are know. For the record -- those who are know. For the record it's unanimous
The next one addresses general desire people have that public and private payers would have the same types of coverage and reimbursement policies and that we would want to make sure that those types of services and tests that are beneficial should be considered, but it recognizes that we're never going to may cleave the ideal. With regard to the private sector, what we could recommend that the secretary do is to have a supportive roam and make sure that private payers have all the necessary information at their disposal so they can make their proper what to cover. change that we made is that we did receive some comments about the specifics mention of pediatrics and. There was another change that we include the word especially to emphasize the prevention and screening types of services, so we put those changes in in response to the public comments. Any additional suggestions or comments with regard to this recommendation, number two?
We see no change. Motion, please, for acceptance
So moved
Second
All those in favor? Anyone opposed? Motion carried unanimously. Next?
The third recommendation has to do with the mixed national local coverage decision making process that we have for cmf. There was lap comment that the task force felt was of consideration. We wanted to the full committee look at it and provide feedback on it. That was if there were a certain number of local carriers who determined that they were going to cover something and we didn't -- no one suggest add particular number but a certain critical mass occurred, then that would or could trigger an automatic trigger of a national review. so if carriers say we're going to cover this, then that bumps the issue to issue a national coverage decision on that item, on that service, on that test. We thought that was an idea worth considering. We didn't consider it at the last minute. We put it as a place holder revision but wanted the benefit of the full committee's feedback and response. Yes?
Actually that's something cms already does.
What is the threshold?
I can't give a specific number, but if there are a number of local decisions, especially if there may be some inconsistencies in those decisions, cms will look into the possibility of creating a national coverage decision
Is it something they can do or might look at? Someone might flag it and say, hey, here's an issue we might consider or an auto mat thick trigger which I think this comment as suggesting an automat tick thing. There would be a certain number and then cms has to take a look at it
There's no automatic trigger
Do you think there's a benefit to a automatic trigger or to put in the reverse, is there a problem with an automatic trigger? Do you think that who create difficulties for cms if we suggested something like that.
I think depending on resources available, that might be a problem in terms of establishing an automatic threshold, so this would depend on the resources available
Ed?
You may want to consider a mechanism that would automatically initiate
I believe they should establish a mechanism
Does that give you a little more leeway? Yes, so should consider.
So should consider establishing.
Should consider. You don't need establishing. I mean, if they consider they'll establish it then they will. If not
There are two separate things, Kevin. One is considering establishing the mechanism. The other is what the mechanism should be if you chose to establish it
If you throw establish out, that includes boakt both of those
Just saying this committee recommends cm spsmd establish a recommendation. They can do what they want with it
Well, if there is already -- James, are you saying there's a mechanism in existence, it's not an automatic trigger for it? Is the case
There's not an
Mat tech trigger. -- there's not an automatic trigger. If there's inconsistency, then we do consider establishing national coverage decisions
I think the value of the sentence is the automatic trigger, which is how its worded. The first part matters less.
Does this capture the way it's edited, may want to? Cms should consider an mechanism that would automatically initiate a national coverage process. Do we need to have should all caps. That sort of shouts at you. We feel very strongly about this recommendation. Any other comments or suggestions?Hearing
We entertain a motion. Seconded. All in favor? in disagreement? Motion carries unanimously. Next?
This is a tough one. eased intoWe wanted to start off with the easy one. All right. We're building. This recommendation addresses the problem that we are eye -- identified in the report having to do with the screening exclusion, Medicare and the challenge that that poses for so many genetic tests and services. As you'll recall -- we have not revised this recommendation since the last iteration. We did receive some public comments on this and we have also solicited some input from cms. This affects them, how the Medicare statute is interpreted. The first part of the recommendation basically recommends that preventive services including predisposition genetic tests and services should be covered under Medicare. It's more of a declaration. We move on to the second mart which urges the secretary to work with cronk and urge them to add -- work with congress so that cms can determine whether something is reasonable and necessary land could be covered. This recognizes that there is a need for a legislative change, a in the Medicare statute in order to cover these types of preventative services and tests, but the third part of the recommendation is the real part. That's where we tried to think outside the box. If you'll recall we discussed this at the last meeting. In some respects it's trying to fit a square peg into a round hole. It's been done before. We thought in the interim because congressional action really is difficult and it's a long process and we know that it's years and years before you might see any final piece of legislation signed into law, we thought, well, is there some creative thing we can do, that the secretary can do within his existing regulatory authority to help cover at least some subgroup of genetic test and services, keeping in mind what the parameters and statutes are. We did solicit some input from cms. We feel -- we don't have a formal opinion from anyone on this, but in looking at the Medicare statute, the screening exclusion is not something that is specifically identified in the Medicare statute itself. It is something that pops up in the course of regulatory, either regs or guidance documents that cms as issued. So we thought, and I should bring out my little handy dandy cheat sheet. Okay. The screening exclusion, cms has interpreted the Medicare statue as prohibiting screening services including laboratory tests furnished in the absence of signs, symptoms or personal history of disease or injury except pass specifically authorized by statute. If you doesn't have signs, symptoms or personal history, it's considered then a screening test and therefore would not be under Medicare. So we thought -- and I can't remember who's responsible for this. I take no credit or blame. I think it's creative that what if an individual has a significant family history of a particular disease, say breast cancer, say every woman in the woman's family has breast cancer. Then could that be interpreted as personal history which would say a genetic test would be a diagnostic test. It wouldn't fall into the screening exclusion. That's the point of the recommendation. It gives the secretary to use his authority to in certain circumstances, however he would want to identify them, say that family history of a particular disease constitutes personal history which would then take the test out the screening exclusion box and put it into the diagnostic test box and therefore be eligible for coverage. Here's where it gets really tricky because I think cms -- cms' official opinion is in any type of coverage for tests that would be considered screening tests really requires a legislative change, a statutory change. We don't have a formal legal opinion from cms more anyone else at hhs confirming what I stated earlier which we think the secretary has the authority to do this. Whether he wants to is another question but does he have the legal authority to do it, I think he does. We don't have any form lamb written or verbal opinion to that effect. So we to whether leave recommendation as revised based on comments that you all may have or whether we want to take it out, recognizing there's some controversy, I think, within hhs or cms whether this would be an appropriate thing to do or whether the secretary would consider it
If I think I understand where the issue is, after having done homework, it is unclear. So the bottom line is what we are clear about is that we want this issue to be explored. So what I would sort of and this is not what my chair had but committee members h what I see us doing here cognizant of my add mow initials earlier. There is an issue of which there is uncharity but there is a course of action which we think deserves to be study. We should ask him to study the issue. If he says he doesn't have the authority to do it, then that's the answer, but I think we're being responsible about sending something forward because, in fact, we do not know, after a lot of homework, or not he does or does not. So let's go forward, ask for the answer and let the chips fall where they may. That's my suggestion
Yes?
It doesn't seem relevant that Medicare criteria includes clinically unaffected patients with a family member with a known mutation. It certainly seems that a known mutation in the family is in many ways Akin to family history, so it's already covered by Medicare. It's a short jump to go from there's a known that I in the family -- mutation in the family to saying that family history could be
That's a local coverage. That's not a national coverage
My question is that before we would send it to the secretary to explore this issue, could someone from cm spsmd actually give us an answer on this whether a change like this could be made without legislative, I mean, we wouldn't just take one step
We've been trying to do that. I think we'll have difficulty in getting something formal. our written opinion. don't think they would willing to do that. It would have to be kicked up to the level of the administrator and perhaps the general council. We have more informally solicited that within the agency, but I'm not sure we will succeed in getting anything more formal
To follow up what Reid brought up, what the seekt should explore the possibility of directing cms to if the possibility isn't there, it's moot.
If it does exist, we do want him to direct t don't think have to explore -- he doesn't have to explore the possibility. If he takes this recommendation seriously, then he will explore t don't think we need to state that in there.
Is there a consensus to leave it?
I would leave it as it was
Looking for a second?
We have a comment on the motion
Can we remove the split infinitive in the first sentence.
taught this man English? We knew that. Which is the split infinitive?
We're looking for a second
To clinically benefit
Did you get the split infinitive? don't know if I accept that amendment
We're looking for a second on the motion. We have a second? All those in favor with the correction of the split infinitive say aye All right. Recommendation by -- we made a real big whopping change in this one. We actually just referred back to recommendation one. This is that we are trying to encourage the secretary to disseminate to states given the fact that they run Medicaid programs as much information as is necessary and appropriate to help them make the best decisions and assess the evidence. We refer back to recommendation one. That's the body that the secretary would establish to come up with criteria, principles for coverage and reimbursements. And we received no points of debate or from the public on this particular recommendation
Accepted
Looking for a second. All in favor? Anyone oppose. Passes unanimously. Also, the one prior to that. We'll go to the next one
Recommendation six pertains to payment rates for genetic tests recognizing that in many cases the reimbursement is below the cost of performing the test, and until the fee schedule can reconsidered in comprehensive way, that direct to use its inherent reasonable authority to adjust, where appropriate, certain payment rates for certain genetic tests. We received no debate of disagreement on this recommendation. Debra?
Can I ask for a note of clarification? Are there rules that direct how inherent reasonable recommendations will be done? This recommendation would go nowhere don't know the answer to that question.
I'm concerned that the evaluation process cms is asked to use, they don't have access to, yet. Therefore, nothing would be done. The overwhelming comments that we got was agreement with having this done. I think we at least have to evaluate the mechanism
It's my understanding they have the authority to go down this path, but they may not have established a path for exercising that authority. Is that what you're getting at?
Right now we've been working for three years to do an evaluation of hcd to pay the same amount of viral loads. They keep going around in circles. They say they don't have the inherent reasonable guidelines to work with yet
I think at the time that was true they didn't have the authority, but recently, at least within the past year, whatever freeze there was on that authority has been lifted. Now I think they're looking
The freeze has been lifted but they are still saying there are no guidelines by which to take lacks through inherent reasonableness mechanism.
I think this is an extremely important part of the recommendation, so I would say if there is no mechanism for use of the reasonable for the inherent reasonableness authority, then we would recommend such a be established rapidly. You could word it, but basically, you know, get it done
Do you think the lang Wang as it's currently written where we didn't say you should consider establishing, we just said do it, and that implies they will consider the process.
I was adding another sentence. I was just adding another sentence to try to block the bureaucratic side step that, if there is no mechanism to accomplish this, then please establish the mechanism
Rather than add a sentence, right not delete the phrase through the inherent reasonableness authority. We're telling them to solve the problem.
I think that inherent reasonableness authority is sort of a road map because if you don't have this in there, the response may well be, well, there is this freeze in statute where we can't adjust the fee schedule because of the freeze and rates. By adding the inherent reasonableness authority it's explaining, yes, we recognize that but you do have this that allows you to make some adjustments here and there
I thought that was the question. the authority is there
The authority is there but they don't have guidelines for how they utilize the authority to achieve the objective
So maybe we need toed something to strengthen the need to -- instead of saying through immediate implementation of it, inherent reasonableness authority or something, that -- stresses it's one thing to have the authority and another thing to implement it or to timely implementation
Or say something along the line through the inherent reasonableness authority. You used the word guidelines. If the guidelines do not yet exist, they should be generated as soon as possible, something along those lines. Then you can add one simple sentence like Ed was saying.
I think the last sentence could go. Or expeditious implementation like Emily said. don't think you need the last sentence then.
Yes. Take out the last sentence
James, is there a problem? Are we -- is this doable? Eye think it's doable. My only concern is the word expeditiously
You and I know what gay lay shale speed is but cms might not.
in the next millennium
From the point of view of a recommendation, I think what we're trying to convey is this is not something we want to just sit around and whenever cms happens to get around to it it happens. We're trying to convey that we would like see a this happen expeditiously, whatever that means in the context of the speed at which government bureaucracies
or a timely manner
I like the word expeditiously
I think -- I would suggest that we need be clear that we want this done expeditiously. What cm) s can do, that's on them. Jim has done a good job that at the end of the day we want this done expeditiously.
any oth her comments?
We have a motion for acceptance? We have a second. All those in favor raise your hand, aye
Recommendation number seven pertains to genetic counselling. This is going to be another tough one. What I think I'd like to do I will go over all these bullets. It's a multiprong recommendation. I think two, three, four and five are not going to pose the same challenges as the first one, so I'd like to go through those and to the first one which I think we will want to spend a little more time on. The underlying premise is the qualified health provider should be allowed to bill for jee he net tick counselling services much the inability to bill was identified as a barrier, a problem, a barrier to access much the very first bullet which we'll discuss in depth encourages or asks the secretary to determine an appropriate mechanism for assessing the credential and criteria that are needed for healthcare provider to be deem qualified to directly bill. The second component of this recommendation asks the secretary to direct government programs federal programs to reimburse long service codes when and necessary, recognizing that times genetic counselling sessions are much longer than a traditional office visit. Therefore it would be in those circumstances appropriate to recognize and reimburse and use prolonged service codes. The third bullet says that hhs a variety of organizations and providers, should take a look at existing cpt, emn codes and any inadequacies should be addressed as deemed appropriate. We don't specify how they should be addressed but urge the secretary to take a look. The next part of the recommendation states that cm ) should deem all nonphysician melt providers deem them eligible for a national provider identifier. The last bullet, the secretary should direct scs to allow -- cms to allow genetic counselling who currently bill to utilize the full range of cpt codes that are available for genetic counselling services. We received a good amount of feedback. I would say the one I want to call particular attention to is the very first prong of the recommendation in terms of how do we reportly recommend who should be able to directly bill for these types of services. There were some comments, again, I mentioned earlier in the presentation, suggesting that we specifically recognize particular organizations, abgc and gmcc, recognize them and their members as being currently qualified to bill independently land therefore exempt from the proposed review mechanism. We received a lot of comments, different versions of that. If think the that we need to ask is how specific do we want to be in this specific recommendation. Do we want to name particular organizations? Do we want to identify particular providers, more should we leave it more generic so it's something for the secretary to determine and for this body to determine. Because associated with the ability to directly bill whether to do with scope of practice. Is someone capable of and permitted to provide services without the supervision of the physician. Is that something we can assess here or is that something best left to a body that's specifically tasked to undertake that
Just for foundational sake again before we launch down this road, know if you're in a position now, Cindy, to summarize, or Susan, to summarize what we spent a couple hours on at the last meeting regarding this point, but the issues -- so let me stop there and ask, are you in a position to summarize why the committee had difficulty at being able to wave a wand and say we believe that these two named ought to be apointinned with the ability be this certifying body or should there be some other mechanism that should be in place. The other part of the discussion was should we leave it to the secretary to try to use his convening power to be able to create the discussion that solved that di lem ma. the question really becomes are we in a position to recommend that those folks be appointed with that role or does there to be a process that figures that out. That's really what I think hour debate was about.
There was some testimony presented, some written comments and feedback that we had requested some of which addressed specific questions that we and in other cases our question he about what are the reasons or how do you justify a particular provider being able to directly bill. Some of those answers were not provide -- some of those questions were not answered. We felt at the full committee level we had extensive debate about that. Who do we pick? Did they present enough information for us to make that determination or are there still gaps in our knowledge. Then at the task force level we struggled. We said this may be difficult to pick and choose at this stage. Who are we to say this group of genetic counselors is qualified. This group is or is not. If we start naming organizations and private categories we may be leaving folks out who otherwise should be included. So at the task force level we thought it be best to least recommendation more general leave it up to the secretary to task a qualified body
I'll comment. I just want to make sure that everybody is playing with the same database as you ask your questions. So one other question I want to be clear about. We asked -- we were pretty clear in hour discussion, at least struggled over how do you solve some of these problems. How do you know whether this should be a masters level person, bachelor. Who gets to create the organization that supervises this, American board, American specialties or genetic counselling. We struggled with all those things and could not resolve it. My question is for foundational sake if in the public testimony that we have received or any consultation that we have received since hour -- our meeting do we have any specificity of guidance of how to solve those problems other than testimony that says you ought to apoint in or apoint. I'm wondering did we learn anything that we did not know that will inform the committee's deliberations around this specific question that we didn't have to us at the last meeting.
We have not received anything formally at the committee level or the task force level that addresses all of the issues that we've identified. I should point out on page -- it says on page two but it's not really page two. It's behind recommendation seven. You'll see a chart. Page two of that chart, you'll see proposed revisions seven pasmd, Cindy and Reed. This is sort of the result of that discussion as a way to reread that first bullet, that first prong of the recommendation to more concretely identify the issues that we face with regard to direct billing, and I think we should give folks an opportunity to read that. Answer to your question, rood, we still lack information that would enable us or any group to make a come prehensive review or assessment has to who should bill, who should not, who's qualified or not. That's how we came up with this recommendation.
We did add a footnote which refers you to the apen Dix that talks about the fact there are groups out there that may be the right groups but we weren't prepared to make that comment
I just want to be very precise about foundational data, and, Cindy, I think you responded to my question, but I want to be very specific about my point. And that is not around the question of although is qualified, but how do you Crete a mechanism -- how do you create a mechanism that decides who and how you determine the organizations or organization that says that people are qualified for certain scope of practice activities. That is a point that we were very clear about needing guidance on at end our last meeting. We were explicit about the dilemma that this committee faced on that point. What I'm trying to make sure -- because I think it is very determined -- is how we -- have we learned anything more about that specific point than when we left out of here last time. Sounds like we do not have comments on that point. That at least helps me. What we know and what we don't know based on last time. I'll leave that there. That helps me to know whether I'm missing something or not has smart about solving certain problems, so please entertain the conversation
Yes, Barbara?
Similar to what I voiced in our last meeting, I guess I'm a little unclear about what remaining questions there are. I mean, we asked the genetic workforce to come up with a report, which they did. It just seems like given the amount of public comment that was given on this, it's we he would take into account. There was a significant amount of comment -- well, the majority of which, vast majority of which supported the -- I think it's also clear that even the way the recommendation is worded now, that that is not to the exclusion of other healthcare providers. It's simply stating at this time, that the professions that are part ofness credentialally bodies or members, sprafer the appropriate training to be able to provide this service and that there may be others out there, but that information is lacking because that information wasn't given to us. So I guess I want to put out there once more to challenge the committee to put those two organizations in this recommendation
I'll just address that and then go to Ed. We received a lot of information the last time in public comments, verbal and written about the nature of the profession, about the value of genetic counselling services and the members of these organizations and the services that they provide. No question about it. Where we are still lacking information is, yes, they can provide genetic counselling services and it's all worthwhile, but your next step -- and I'll draw your attention to the flow chart it guides us through the decision making tree as to whether someone should be able to directly bill, whether it's Medicare in this case or a private health plan. far as genetic cob sell or -- counselors you immediately go to the yes question when you ask are they qualified, a resounding yes. There would be no dispute on that the next question are they qualified to provide genetic counselling services without supervision services. If it's no they have to bill. If yes they can bill private payers directly, but, still, there's another decision tree they have to follow in toured bill Medicare. These are scope of practice issues as to whether someone should be able to bill or provide services without physician supervision. There's also the question of the credential that a particular organization, the credentialing requirement that an organization has. Are there specific criteria that we think any credentialing body should have so any blessing they give to their member is deemed adequate? don't think we received any detailed information that would enable us to make a very specific recommendation in that regard. So that's why we were struggling at the task force of the fearful of going down the path of naming particular organizations sort of a long winded response. I know Ed has some points, too
I guess I disagree with Barbara. I think by having apen Dix d, I thought the footnote was a masterful way of dealing with the issue without appearing self-serving. You would use the criteria for those two organizations, obviously in abenediction -- apen Dix d, so you do sing tell out but don't put it in the body of the recommendation. So I refer that approach. Reed's comment about the structure, someone could set up a fly by night genetic credentialing service or nondoctor at level people. don't think that's our business. I think that's the business of the genetics community to establish that in order to prevent that from occurring. I don't see that as a federal issue.
By the way, just for the record, I don't disagree. was to get clarity. you're right. I think the point was what we got to in that discussion, as I recall, was we could feel the pressure and the pain from the genetics counselling community for faster action, so we what we had been debating and kicking around-- I'm just trying to clarify where we were in terms of how we got to where we were. Because felt the pain and the frustration of the genetic counselling community to get this moving faster, we were sort of wondering could we request the secretary to use his good offices to stimulate that kind of conversation to be a convener that would move this forward so it would support the genetics community in getting that done. We were hoping to get advice and guidance on how do you make something like that happen faster. It was trying to jump start the process as I recall our
Agnes and then -- well, Agnes, Barbara and Silvia
Reiterating what Reed had said at the last meeting. I think one of the key issues we wanted to address was the issue of genetic counselors becoming recognized providers to able to get reimbursed for the services they provided. I agree with Ed, though, I think it's appropriate that we don't specify a particular organization. In many way was we want see a happen is jee net tinge counselling services whether it's genetic counselling quote or genetic services provided by other providers integrated into medical care. I think the oncology nursing society had asked us to define what we were talking about when we said genetic counselling and other types of services. I'm wondering whether we should ask for reimbursement for genetic counselling for the counselors but may be recognized as providers or doing these services that are reimbursable under the management code. That's what we're asking for. Rather than making jee net Nick terminology of creating another category, let's integrate that into what is existing but get the genetic counselors recognized as billable providers.
In follow-up to Reed's comment about the secretary in convening authority, I would think that the people sitting around the table already have that message. If we wait for it to go up to the secretary and come back down, that's going to take quite a long time, as we've experienced, but perhaps we could ask groups like cdc, nih to think about and perhaps report back to us what it would take to convene a group of these jee net fix professionals, genetic providers to think about developing. So without the government being responsible, it could at least be a catalyst to bring people together. Is that clear
To me has one listener it's very clear. It's a different strategy. I think at the end of the day what I'm hearing here is another member of the committee expressing an interest and a desire to try to move forward to accomplish a goal that is so clearly articulated to us by the genetic counselling community. You're trying to shovel that by instead of -- trying to solve it, instead of weighting for the secretary but to get it done. If I'm he hearing you it's another way to fast forward the process
Would you be willing to take -- to try to put together a group that could begin to think about what it would take to have a -- an umbrella that would say this is a legitimate genetic provider credentialing group so that we could prevent what would undoubtedly happen without that sort of umbrella
I'm not sure that these are mutually exclusive. I think if you put something to the secretary, the secretary will come to us anyway
It will take a lot longer
A lot of the activities and recommendations that this and other committees have been making have been taken up by the agencies by elevating them to the level of the secretary. I think this committee is more likely to make a more lasting impact. In other words, leave the recommendation here but a group of us can begin the discussion about how is the way do waiting Marching the secretary. I mean, you can have your cake and eat it too, but it's not going to be easy or simple either way. There's no need to exclude it from your recommendation. If we've already started the process, if we haven't, then he or she will lean on us. If this shall you were easy -- if this issue were easy to solve, I have a feeling it could have been solved many years ago.
I don't she that that rec men -- I don't see that that recommendation is here. Is there a recommendation under the convening authority of correct to do this? That's not here, so that would be a new recommendation
It's an appropriate mechanism. It's just unspecified, which is in the spirit of what we decided to do. Simply urge him to go down a path that he feels is appropriate.
My comment would be I applaud the chairman for his efforts to be extremely even handed here and you're being successful. On the other and, I would us to focus on the words, something we can all support. I don't sense an e another must amount of -- an enormous amount of disagreement around the table. I agree with Ed. I think this is a masterful decision to add this footnote. I think this gets us as close has we can get with providing the information necessary. It may not satisfy every group but from what I heard about the -- around the committee, there are legitimate reasons for not going in that direction.
Bar brarks Silvia and then Emily.
I think the -- I can understand the -- Ed's comment about not trying to appear self-serving. think the majority of people -- I think that in this recommendation to reduce it to a footnote that they should consider the credentialing of abgc or the advanced practice nurses reduces it to a footnote. I think somehow the wording should be put in actual recommendations because a lot of times I'll get the recommendation but the footnote won't be included. I don't want that to be in the recommendation
Some of the comments though that we received were not to the extent of mentioning those organizations specifically but also saying anyone no is member of the organizations and by them should be except from this review process. That's a different step that goes beyond simply recognizing the organization
I agree with Ed that it means organization, that they get except would be self-serving, and that's not what we want to g I don't want to reduce it to a footnote because I believe that as Reed said we're looking for foundation. The evidence is that the majority of people who provide jee net Nick counselling are genetic counselors or advanced practicing -- pray Tishing in nurses. I'm saying use the wording that you look at those organizations in the recommendation, not as a footnote
don't think there's any problem with putting it, instead of as a footnote putting it as part of the bullet. I agree with Silvia.
You can specify what's in b. Have developed credentialling standards and put it in appendix b if that's a significant issue
Emily, Agnes
I also agree dhis is a good compromise. I think my biggest concern is I didn't want to give any appearance that somehow this committee has apoint inned itself as a -- apoint inned it so as one that could deem groups as having certain categories. I think that has to be left to groups that have that authority. We're an advisory committee, we're not a committee that will have active oversight or interviewing of different groups to determine if they, indeed, should be allowed to billable entities as jee he net tick coun -- as genetic counselors.
It mentions that the oncology nursing society has their own seer ti -- certification to look at collaborating and helping ons come up with their own certification or credentials for nurses, so that, I think will happen. If we give the examples, professional organizations that already have credentialling or certification bodies will make use of the cry tear that, apgc and has in establishing certifications. I think the issue giving -- is a better way to go. When we say to recognize the gncc certified providers. Nurses can already bill, so they don't have to go through the mechanism of even going through the gncc. They are nurses trying to get an extra credential to slow they have the specifics specialty in genetics. So they're already billing. I'm coming back to that point under evaluation and management code. don't know whether in this whole document whether we're actually asking to create another billable entity for genetic counselling, and I would still suggest we look at it as an integrated process and have the genetic counselors bill rather than establishing a specific service for which people are already billing, other qualified providers that have their u pin numbers.
My question is, is that the wording that you have up there right now? That's what we've been talking about
What this is is sort of the tuckson-berry amendment to the original rec men daismghts it has been modified to reflect the comments. We took the footnote, was previously a footnote and moved it into the body of the recommendation. This is really lain attempt to clarify the issue of direct billing and kind of going through the decision tree in a -- an actual sentence structure as opposed not chart
Cindy, you're taking out the first bullet, so you're removing the bullet and this is the full recommendation without any of the bullets below it?
this is just the first bullet. This replace the first
The first nonbulleted part?
Under recommendation seven in your thing here. There's one, two, three, four, five bullets
Right
This wording up here is intended to replace just the first bullet
So it's just not bulleted
Right
Okay.
Okay. Just one other comment
The provider should be able to bill without supervision of the physician. As deemed by the state practice act. In Pennsylvania nurse practitionerps that cannot provide services except incident to the physician and that's deemed by the nurse practitioner practice act. So although they are aloud to be billable providers, some of the supervision will be by the state practice act. Hoop should be scope of practice laws. Are they on statute or at the state level? What's the best way to characterize?
From what I -- it's not the profession scope of practice. It's the state
The state scope of practice for that particular profession
Seems like each state
But it's the state's not -- each state. State with a capital s probably. I think you have to add for each professional group. I mean, is it --
The next sentence was really designed to get to that point, wasn't as direct and didn't mention state specifically. Should we eliminate that sentence. The addition of the language about the state scope practice laws, does that ob vie ate the need for this next sentence
I would get rid of laws. I think you'll find some mix of laws and regulations. Make this policies. Then it covers whatever it is
Or requirements?
Requirements.
The criteria used. It needs a d on the end of it.
Is it just jee he net tick counselors or others that may not have a scope of practice, criteria or laws.
I know the genetic counselling community is actively looking at it. In each place they're looking to get the license passed, that's one of the things they have to define. If think the organization, in general, will be looking to develop the scope of practice that could be presented to each state when they look to get licensure
I'm going to add vow Kate a little bit advocate for the version, if you think, if we can tweak the next sen terngs the cry -- sentence, adding the other stuff makes it difficult top understand. If we can get it back to the way it was and start a new sentence and add that might be
Why can't you take out with was added and put in the criteria used should consider additions that we made to the first sentence. in the state
It's all inclusive. It doesn't matter if it's state, local, federal
I agree. I would take out the additions that we made, leave it the way it was. If we're going to wait for each state to pass laws or regulations to accept genetic counselors, it will be slow are than galatial.
It was my understanding you had to be licensed at the state level.
there will be uniform services where they don't come under state.
I think we're both agreeing on even though it is the case that federal practitioners have different requirements than those in private practice, the fact of the matter you must be licensed in least one state or jurisdiction. So ultimately licensure is at the state level for all practitioners.
I would still recommend that we leave it, leave the state out because it will come up. That's the scope of practice. It's state based
We're not excluding them, in other words
I'm fine with that. I want to come back to being that I already said this will be my third time. Three strikes and then I'll be out. I think we're missing a tremendous opportunity with some of the wording that we currently have of looking at how what we're talking about could apply to all of healthcare practice. This is, I think, one of the things that we have been chartered to do is look at how genetic services are going to move into all of healthcare and I give as the example in cancer care we are already providing genetic services and genetic information to patients who are now having genetic tests done for tumors, and it looks like even for the area of colon cancer a rec men decision is out there to have msi or genetic testing done on the patient. That means they to be knowledgeable about genetic information and providing testing for a select group of patients so that those will probably be referred to genetic counselors but that healthcare providers in general, oncologists, nurses, surgeons are providing this genetic information. I think we need to keep this integrated approach in our minds and that maybe another group that we should in our list of -- not that it's a certification organization, but would be niche pesmg they have come out with established competencies in order top integrate genetic information into the up and coming healthcare system. If we need further information I see gene Jenkin in the audience who helped develop the core come he ten sis. The uk healthcare practices already have integrated the competencies that were put in place by niche peg, their recommendation for all healthcare providers must have these specific competencies. I would hate to see us miss this opportunity to integrate genetic information by just focusing on those who will be working in this specialty area. That's the third time, and I won't say it again
But, Agnes, it's not a coverage and reimbursement issue for physicians. They can bill for that already. So it's not really a coverage and reimbursement issue as much as an education issue
I think where we start to look at determining the qualification, it does become an education issue
Building on what Debra said, we might want to look elsewhere in the report where this issue can be addressed. It is a coverage of reimbursement report but we address other related issues. Keep in mind, the problem that we have is the recommendations we're looking at wording in isolation. They fit within certain chapters or sections of the report dealing with certain barriers. The barrier was that people who provide genetic counselling services, a will the of them can't bill, so this is designed to address that sfwha. you're talking about is something bigger, broader with a bigger scope but it might be appropriately addressed someplace else in report, perhaps not in this recommendation but maybe we should take a look.
basically what you have, this one is addressing people trained to do genetic counselling. The other those who trained who can bill
I just want to support what Agnes is saying. I think the intent of what she is saying should be reflected in the report somehow
I think Agnes -- the recommendation would be in number eight, the next one.
I think that might be a good spot for it. Are there any other? Barbara?
What we have come to has settled better than what we had before. I feel compelled to say I think we all need to appreciate this is more than a self-serving issue, that it really is an access issue. That was kind of the whole purpose of going down this path was to increase the amount of -- to allow more of the public to have access to these types of services. As we talked more about it, it was very much linked to this coverage and reimbursement issue, so that I guess this takes the focus off it's not just that genetic counselors want to be paid to make a living. But they need to be able to bill and without that, individuals in that community would have to travel hours and hours to get to services. So I want to make sure that stays in the front of our mind, that is the purpose of this whole recommendation
Are folks satisfied with the tuck son-berry amendment. The first bullet, we haven't gotten to the others yet, but this is probably the hardest wunlt all right. Let's go back to the recommendation seven list. Do you want to vote?
I was thinking what were you saying? Why doesn't we do all of seven -- why don't we do all of seven
Even without a formal vote, so we'll do it all at once. So it's locked away. I'm looking at you in the eyes. All right. We see you
Aren't there guidelines about the chair threatening the committee members. All right. How do we get to the number two bull left the second bullet has to do with prolonged service codes to reimburse. Does anyone have problems with that? Edits, suggestions? Emily?
So the only question I have on that was I felt one of the issues was even the prolonged service codes aren't prolonged enough for some of the jee he net thick counselling services. So do we need to say something about's stabbing codes that have appropriate time frames for genetic counselling?
The following bullet we go into assessing cpt codes, dme codes to determine their adequacies
Maybe we should reverse the order of those two bullets
That might help.
Did that do the trick? It's hard to tell. We're having formatting issues. But we just moved the third bullet to be ahead of the second bullet
My memory on that shall you was -- although Emily's point was one of the points we considered we didn't want to be on record trying to tell people what the right amount of time was for genetic counselling services. Physicians are supposed to see patients every 15 minutes yet don't think any physician would claim that was adequate
I'm fine with just changing the order and having it handled that way All right. We kind of moved to number three. Let's take two and three collectively. Any changes to any of those? There are none. The next bullet. This has to do with national provired identifier.
Can you clarify the problem that this is supposed to be addressing? Because I'm stumbling on the use of the word currently here. The word currently suggests if the secretary changes anything or cm) changes anything then this recommendation would not go forward to the new people added to the list. So is the word currently needed?
No.
Currently they use a unique provider identifier number as their system. In they have a new system that's being implea mtd called the national provider identifier. Anyone can build any health plan in the U.S., so the currently is inserted just tran siption point.
Is there a way to refer rather than using this term which -- I mean I agreed with hunt until you made that point, but it's kind of an arcane point of what the interpretation currently is. What is the system referred to now? Can just specify so in reading this Tway and thinking currently in 2008
. Can we name the system that is currently
Can we get the attention of Susan and sen di first
We're trying to figure out is there a way to mention the current existing mechanism.
Can you say prior to 2006 or prior to implementation of the national provider eye den fire -- identifier would be another way.
I think there was some testimony saying you should not take it out because you can do it already
Didn't Susan say starting in 2006, though, they'll start it, so, you know, by the time this report comes out, they'll probably have it
Do you note answer to this? I mean, is it already done?
Currently we're using the u pin number. As of January '06 it will be the national provider identifier number
Will there be a natural transition? Everybody who is currently under the current system will move over to the new system?
I will make the assumption. I'm not sure. Their heads are Bobbing up and down.
Here's the issue. There are some people who do not currently have a u pin. Therefore, they wouldn't be swept up in the transition to you a matcally rehe ceive the national identifier, so this is aimed at that little group. I couldn't tell you who they are, but apparently there is this group. If they don't have the u pin we want to make sure when the npi takes effect that they can be directly billed
That's not what this says. It's getting more and more are a cane, the more we discuss it.
Are we overreading this that basically if you are able to bill directly, you need a national provider identifier, so we're simply say they should be eligible to get it. If they are eligible and the point is moot, then we don't have to worry about it. So take out currently and you got this done in. Currently goes and it's solved. Going, going gone. Next? Just take out currently. It's a fill low soiveg equation. So we're down to the last one. Don't get happy because you're still going to have to work. We have one more thing to do
All right. The last bullet here -- this addresses the issue identified in the report that having to do with the inadequacy of certain codes and it's asking the secretary to direct cm spsmd to direct nonmi signatures health providers who can provide genetic counselling services. I think there was somewhere in the report mention of the fact, if I recall correctly, there were some codes that were not widely used.
They can only use 99211cpt codes. There are others that may be more appropriate. This bullet within the recommendation seven is aimed at that particular problem
What was the difference?
Consistency in terminology
Thank you.
Is the attachment going to go to part of the document because I would offer correction to it if it is?
The chart, no. This is just for our discussion
The terminology certifies nurse specialist is clinical nurse specialist, is how the profession addresses that group of people
The chart won't be part of the report or the recommendation
The chart was for -- to keep us straight
Could I also suggest that we move this last bullet up under what is now the second bullet, so that we talk about vault vaulting -- about evaluating the codes. It would be now the third bullet.
Okay.
Just moved it up.
I would like to react to Barbara's comment earlier about the preamble and consider adding in the second sentence it currently reads as such, SACGHS recommends the following. Clarify the motivation, get it out there land take the high road
Stay again.
to ensure full access to genetic counselling services
Okay.
Need some anger management
I would believe as such. Nothing's wrong with as such. To ensure full access to genetic counselling services for all Americans
To all Americans
Or for, access to or access for
Access to.
All those who live in the -- all right we have a pretty clear statement. I think it's a very nice addition. Anyone concerned about it. We have a full range of recommendations that we have discussed at length. I am looking for a motion. I'm looking for a second. All approved raise your hands. This was unanimous. Let's move on to the next one.
I just want to applaud the committee for being both logical and consistent
Can I make another motion. Take a break now?
Okay that's a pretty good thought. We can take. Here's how to works, though because we want to be fair to you and your brains. At 4:00 our Fred comes in. It's for a ceremony, which we are looking forward to. Then we come back and continue to work. So why doesn't we do this -- don't we do this. Let's take a five-minute break now and then we just keep plowing through until Reynard comes. Let's take a 10-minute break. 15-minute break? We're way ahead. You want a 15-minute break. Okay. 3:30 is a convenient round number. 3:30. Test test test test testCap audio line is ring busy. --
Captioner: Audio line is ringing busy.
The electronic record czar. Motorcycle -- Mike. Anyway, I mean the guy in charge of the health information technology, you know, caused there to be a public-private partnership to create a certification tri-- cr tiria for electronic medical records. Government can't do it, but they can say we need people from this community, this community, all of you all, come on into the conference room and now we, we, because you are all in one place at one time, we urge you to take on this charge, this goal and make it so. Then, the private sector or whoever it is that is responsible goes forth and makes it so. Thank god the government was there to be the, the sand in the oyster to create the pearl. As it were. Cata lick -- catalytic opportunities. What I think we're trying to get at. Please be comforted, those in the audience, worryd that we're somehow feeding to government powers. The wording is very clear here, and the committee has tried to be very precise. I want to make sure that those not grasping with this at the table are as on the same page as those of us who are at the table. It's responsible call for government leadership to cause something to happen that meet not and well may not happen, were it not for the convening power of the secretary of health to identify a problem, raise it up in the light of public district attorney as a priority, and then urge the appropriate people to come together to solve the problem. And that's what this really is all about. Nothing -- more, nothing less. So, having sayssaid that, I hope said that, I hope were quick. I don't want folks in the audience to feel like they're going to go, because I'm going to you what is going on to -- to happen. It will drive poor Sarah and the team crazy, if yoke -- folks don't under-- understand that point, we'll -- they'll go back tout out and talk about it in government circles. We'll try to answer 5,000 e-mails by the fact that we're feeding to the government it doesn't deserve. Again, it's responsible leadership to identify a problem and cause the necessary people to come together to be able to solve it. That's what it's all about. All right, moving forward and until Reynard comes, I'm going to keep pressing by the way, the people who raised in -- this in the hallway with me, thank god. It would have been terrible if you have the miscopsings and concerns, not only misconvention -- misconceptions but concerns. Your council in the hallways and the lunch breaks and the bathroom, I don't care where it is. It's wonderful. Don't stop. We love you to death. Besides, I don't believe any kind of committee gets the loyal folk hanging in there every meeting until, until the, you know, the clock finally ticks, say, we have a group of people who pay attention. Thank god for you, we would not be as good as we are. We would not be that good it were not for you. Thank you, and moving on.
Thank you. Okay, we're on recommendation 8 and this recommendation pertains to education and training of healthcare providers. The e -- edition in red come says from -- comes from a public comment we received suggesting supporting studies that link education and training tools to improve health outcome. This particular change that we mentioned helps outcomes but it does say that the secretary should provide financial support for assessments of the affectiveness of educational and training tools, and I wanted to also bring August bring us to a point that Agnes raise -- raised earlier, about integrating and training health professionals and making sure they were able to integrate genetics into their practices, and I wanted to get her input because there might be tweaks that we might want to make to the recommendation if it doesn't curleaptry address her point ad"ly, we -- adequately, we meet to make -- make changes.
Dieent -- don't know where this might go but some type of beginning comment that would say something that since the effect of genetic information is being integrated into all aspects of health care. and providers act as intermediaries. I don't know if that would sort of do it, and then the other recommendation that I had made earlier was that where we're giving the examples so that about midway down the paragraph to hhs agencies who work collaboratively with state, federal, and private organizations to support the development cataloging and dissemination of case buddies, practice models and genetic competencies as propiece error read by -- proposed by Indiscernible ] In parentheses.
Is this sort of a regurgeitation a recommendation we made in 2004. Does that language that you have, was that what we side it's in 2004? Or are you seed adding something new?
No, I'm adding something now.
Right, this of the recommendation?
Simply say -- says back in 2004, this is what we said. It's regurgitating what we said. So, is what you're, we can't change what we said --
we can
Can we put it some knows else.
Yes. We can't. So then specifically to look at the genetic competencies for all healthcare providers as recommended by .
Should way add another separate standalone bullet? The first part is kind of an introductory love thing saying what we recommended before. The blue change talks about supporting studies, the effectiveness of training tools. Should we amend that or do you think we h we should add a separate part to the recommendation that addresses? Your suggestion.
I think you could go with a separate bullet.
One point is that the genetic competencies are put forward by several groups. Not just -- .
Okay.
I'm not sure again.
Could key -- we say such as? Pegging me and the organization other organizations.
There cob a dozen organizations, depending on where -- getting dangerously close to where we've been.
Where we have been before. Okay.
The blue and/or red, depending on whether you're looking at the screen or the printed page, the wording of that is ambiguous to me, and maybe it's purposely, so on your part, but affectiveness is not clear whether it refers to affectiveness and training, where affectiveness or clinical a -- affectiveness because of that training. And the public comment certainly by referring to health comments made me believe it was the second, not the former. So if you meant the, it to be related to clinical outcomes, I would probably say something like provide financial support to assess the clinical impact of educational and trapping cools -- tool and training cool tools. -- tools.
I think we could add something about the competencies at the end of the sentence. For education and training and health providers and genetics and genomics to a level of accepted some kind of --
all healthcare. if push came to shove, won't you rather have the -- you would regarding assess it against clinical impact than you would against some stated list of genetic competencies, right, if you're relating it to outcomes, you're relating it to outcomes which, is a more direct measure.
What if we had -- sometimes when I think we make amendments, we create these monstrous sentences, so we should break it up, I think, into two parts and the first 35R9 is funding studies to link education and training to improved outcomes. Then we can address the point about clinical competencies in some way. I think there is probably a more direct, easy way to address that point by creating a separate sentence. I think I would add a period to get rid of the rest of that.
Okay.
How can we add -- how can we address --
Make it can be added at the first sentence? I'm not sure what is nod -- not side -- said by the first sentence. We're asking for support of ongoing training and continued education of health providers in genetics and genomics. Maybe you could add to achieve genetic competency, but I don't know that that adds anything to what we're already stating.
I would argue that you could add something as another sentence here that would be in, essence, saying that health providers who are utilizing utilizing, or who are giving, providing genetic services should meet an adequate level of competency or something like that soak that all of it leads down to the fact that there needs to be some -- certainly all physicians can bill for genetic services, but they need to meet some level of competency, and the way you get them there is through all the stuff up until that. We don't hold them accountable.
-- Agnes' we're going to stop thinking of physicians as providing genetic services and that it's integrated into normal practices of medicine. I don't want to create an exceptionalism view of. This we want to do is see genetics education rolled out in such a way that it'sint -- integral to the competency in all faces of -- phases of medical practice. I think that was -- that's what Agnes was trying to get to. I agree, but I think what we're trying to say is that -- because I see yet now as people are providing genetic services but they don't really have the resources; the resources to provide those. The information is erroneous and so saying that people should get educated is a good thing, but then I think they need to be held accountable at some point as well. And I think that was the point of saying that they need to come to some competency level, you know, in their knowledges of genetics as it relates to their particular whatever it isy that do in the practice of it is that they do in the practice of medicine, back tick -- practitioner, physician, nurse, whatever allied health professional.
I don't know how much editorializing or justification we want to do, but in relation to Agnes' first sentence, it mean worth, putting something in there about the fact that, yes, genetics is permeating medicine and providings -- providers are acting intermediary, and they also consistently say that they're not repaired or do not have efficient training. Dieent know we want to justify what we're saying in those terms, but certainly that is Indiscernible ] Comment.
And it's documented in the literature, too.
keep thinking, the whod -- word keeps popping in my head that we should emphasize somewhere that the educational and training tools. We're not just talking about professional -- professionals in training or residency or in schools, but ongoing training for providers who are in practice, and that she's tools should also, increase in addition to ultimately leading to improved outcome, facilitate theint gas station of genetics and the integration of genetis genetics of genomics in nursing or whatever. So maybe if we can get the two thoughts, two feel -- goals, really, one is to assess the clinical impact, I.E., I -- improve outcomes. Before can you get there, the fresh -- threshhold is the toolsa have to unable DOCs and nurses and councilors and everyone else to integrate genetics into their practice areas.
We have German going in there.
I thinkid would be remiss if I didn't mention concept of diverse populations being served, particularly with a 10-year lag time of research to patient bedside, particularly important to genomics that we have the opportunity that all populations ultimately through the tools get served, so, somehow it's a concept of across diverse 51 -- populations and multiple populations could -- coulding could be employed somewhere in the paragraphs, I believe it meet strengthen the comment.
I'm going to also sort of break, Cindy, one of my little rules as chairman, and just sort of raise a question. I hate to bring things back, but I just, for the first time, sort of read in a different way this first sentence. Since provide -- providers act as intermediate -- intermade areas bean -- between plans and plan members, it never sort of leaped out at me that that's a little strange. I don't think that we view the role of the health professional as an intermediary between, as if there is an essential diad in healthcare Ben -- between the plans and the members or somehow or another, the health professional is intermadeiary and very much for helping out. I sort of seat the essential diad as being more the professional and the patient. So we meet the -- want to just -- . I think what is meant there, use is suzann remindd me, I think, in a sense the gatekeeper function of provider. other words, the provider determines when a test is ordered and when a test -- it's not -- doesn't have to do with the health, you know, providers to an interpreter or insignificant middleman role, but mainly as it comes, deals with access oh -- issues, it's the provider and the health plan kind of determining what a patient would have access.
I think like was said, that's not at all the primary way we see ourselves -- ourselves when we are dealing with patients. That's a secondary onerous task.
I don't think it adds an amount anyway. What was the reason for the language to be in there? I know what was meant by it. If we remove it, are we losing some critical thoughts that someone this -- someone had -- .
I think could stick the access back in there. You can get rid of intermediary and make it clear that since, you know, the providers froside -- providers have an important role in ensuring access, critical role in epseer -- ensuring access.
I think, given what thence of the sentence is, there needs to ab an ongoing training and providers of healthcare and genomics. We need to point out, I think, Dr. Evans said if there is insufficient -- they're insufficient totran at the current time. Because the way that's looking now is genetic information fee integrated and the providers are going to do this, so it doesn't really follow that we use all of this education and training without stating that providers, a majority of providers are inadequately trained current limit or something to that affect.
I'm going to -- going need to do one short process check and trust in the attention span of the committee. It's 4:00 exactly. And I need -- Reynard is here. I need to suspend for just a moment what we're doing and also because I have to step out for 10 seconds. Also simultaneously and I didn't want to lose the opportunity to introduce Reynard, and also for me to say, also what I wanted to say far as our three committee members who are going off. Reynard, if you could come forward. We know you well, but let me introduce formally for the record. Reynard Kington is the deputy director for the NIH and I can't think of a better person who has been with us since the beginning to present the mementos that he's about to present. I'll step out and turn this over to Reynard as a personal point. I have learned so much from Ed McCabe. I have appreciated the couple of Barbara Harrison and Joan Reed, and I think you're terrific people and the worse for having you going forward. I hope you will with us. I -- let me turn this now to Reynard. soon as he finishes, would you turn this back up?
Great. Thank you, it's pleasure to be here eveny to my good friend Reed is leaving. No, please, please. We have to use our time efficiently. Thank you, it's a pleasure to be here rather than -- the secretary and Dr. -- Zahoney, and honoring three of the committee. This committee is important to the department in helping the agency to come to terms with the medical specific, ethical, legal, and social issues related to the development of the use of a genetic and genomic technologies, and I was here the fall, I believe, at a meeting and it's a pleasure to really recognize three members in particular who are rotating off. First, Dr. Mccabe, um, yes. Whom I met, I believe, last tie -- time. Thank you again on behalf of the department for your service. I know you have particular interest in genetic discrimination. As Reid said, I heard great your contribution to the committee and s for your service. -- thanks for your service. Flaws flaws.
Next is
Next is miss Barbara Harris. Thank you.
I know you have been involved particularly in genetics, training and issues, again, on behalf of the department, I thank you again for the service and commitment and effort. Thank you. Applause ]
And the third person is Dr. Joan Reid, who is not going, who was not able to be here today. I know Joan very well, and I know many people around this table. She was appointed to committee of her expertise the area of public health and community outreach, involved in a number of initiatives including a survey of organizations to the on the activities of genetics organization and training. She's chaired a round table on the topic, was involved in drafting and finalizing a resolution on genetic information and training given to the subject -- secretary in August 2004 and has made great corrections to this committee. I want to forewarn all three of you, though, because your service is ended, doesn't mean we won't call upon you. We have no shame in asking number -- members of various constituencies to advise us on how we can go -- do's better job with our polls -- policies. I understand there are four new members. Sylvia, Tyra, Jim Evans and Julio. Is there is that anywhere close to correctly being pronounced? Welcome to the committee, and you will one day have the privilege as well to have a plaque honoring your service and we will call upon you again as well. Thanks again again for your service. Applause ]
We'll just comment, the ceremony, somebody made the comment that dementia is lined with plax or something.
All right. How about this. Agnes. Okay. We're going to need your help. I'll just read it out loud but you can follow it along. Since genetic information has the potential to be integrated into owl areas of health care and providers have an important role of ensuring a appropriate act of genetic tests and services, is a critical need to support the ongoing training and continued education in health providers and genetics and genomics and it goes on to reaffirm the recommendations that we made -- made to the secretary in 2004, recommendations that included blah, blah, blah, and then we still haven't fixed the last part. is that, let's take the first paragraph. Does that capture what people are getting at? We have to fix the second one. I want to make sure the first one is okay. Okay. All right. The second part. Let's skip to the studies. Financial -- .
We haven't done the first art part and may be it needs to be a separate one so we don't get to many run-on sentences. We need to acknowledge the diverse population.
Oh.
somewhere.
Should we have that in the part about ensuring appropriate access to genomic tests and services? You want to add to everyone or to not just for them but for everyone, including Indiscernible ] Okay. Diverse populations, period. Does that do it? All right.Well, all right. So here's the question. almost thing think we don't to have the sentences.
You almost have it. You can combine those two. Just say these tools should enable health providers to meet standards of genetic competency and to thereby, integrate them into the respective areas.
And two thereby.
Competency or competencies. Singular or plural?
The genetic conferencing.
Plural standards, you have one and singular competency.
The term of arden reg -- regular tomorrownology is competencies.
Right, then you don't need standards.
You don't need standards at all. Our to meet a standard of genetic competencies. They can't have the same -- I'll take standards out. You want to take standards out? I like it better just meet genetic competencies, you think?
There certainly can be different standards for different levels of providers, et cetera.
Okay.
Thank god Reed's not here. I'm going bring up something from the past.
I won't tell him. Go ahead.
Just as what we recommend is one of the tools to help the education and training was only one of the aspects in that 2004 report. And when -- and it makes it sound, even including to say one of the training mechanisms or -- remember we had all of the, we had all of the suggestions for integrating genetic information into credentialing exams, what could be don done for ongoing information as training a faculty. This was one of the recommendations that was made based on the survey that we did with the health professional organization, and they said the providers needed the tools to see how it was applying to the practice. This was that was just one aspect of what we were look at with the education recommendation. So what, do you want to emif size that?
Makes it sound when you say which included, makes yet sound like that was the complete list.
Include side like --All right.
Included sort of included these things but there were more.
Okay. All right. I was we should discuss this. I would say meet adgat -- adequate genetic competency. There -- that is usually at some level adequacy. To meet, to meet genetic competencies, I think we should specify a level, and I would say thereby to integrate genetics effectively into their respective pass. -- practices.
Does adequate sound good enough sore or does yet sound week -- like we want a lot of mediocre -- . Can you put establisheddom tenseys? Adequate is -- who is adequate? Some of them have established for ever Reporter: Think it needs something more than to date to say genetic competencies, that seems too vague. Establishes the -- thatp
The words "tool to --" tool "to me -- .
Come over here.
Doesn't seem -- it's educational training programs. The tools are part of the programs. The tool seems to be a very particular subset of what we mean opposed, you know, like a checklist or anything. Those are the tools, but it's the larger training programs and educational programs that we want to support for. Would you still call it a program if you're talking to a DOC who has been in practice for 20 years and you're providing him with some kind of cm or -- was that a program still or
A short course. You think?
Just call it genetic education and training.
Yeah, right.
Don't have -- .
The appropriate tool.
More adjectives.
Get rid of tools. Impact of genetic training?
Gauze -- because it asks the question what are the tools. We don't define those, we describe them. Okay. How's that.
And the second sentence, you need to change the -- .
Tools.
Right.
Right.
Trapping should enable to help providers training should enable to help providers for education, training and education?
I'll go education rather than training. Training is the old-fashioned way.
Or these efforts could be -- okay any, other charge?
Come back to that initial paragraph. You think that we should say, though, that if -- the recommendations, not reading it off the screen there, regarding the education and training of health professionals, so It's a reference back to the original document that we sent.
It was just reminded that there was a resolutions, old resolutions that we came up with. There is a specific document on that. Just as a reference.
I think it means the secretary Indiscernible ]
Reaffirms the recommendation it made to the secretary in 2004 regarding.
Okay. Can you imagine, if you haven't done that routinely, my god.
Yes. Can you slow -- scroll down a little bit, just go down, come down a bit more. I want to show you -- okay, the selected revision selected by public comment and recommends supporting studies with education and training tools to improve health outcome, okay. This is a document about coverage and reimbursemet. It's not about education and gen-- genetics. Of course, it goes hand-in-hand. I'm feeling we may have lost something in the translation because we're talking here about making a set of recommendations to hhs about coverage and the reimbursement of genetic services that should be evidence-based and that should follow all the other recommendations and somehow, this recommendation has evolved into sort of a catch-all stuff. Some of sort, and maybe I would like us to go back and rethink a little bit why we have the recommendations to be -- begin, and what are we trying to do to answer the answers about linking the training of the health providers with improved health outcomes because at the end of the day, you want to show that coverage and reimbursement of appropriate genetic services can lead to improved health outcomes among patients and the population, and you would like to thank -- link those things together. I'm just reopening the discussion a little bit because that's what the task -- task force responded to. Somewhat somehow, this paragraph became something else.
On to answer the first part of the question. This recommendation, again, it's hard for us. We're taking them in isolation and it's hard to see the context. Where it fits is is -- fetes in in -- in is under the report of provider and educational training, mentioned as a key component to coverage and reimbursement in so far as if a provider is not property traind in the area of genetics, they don't know what they don't know, and they won't necessarily, um, provide their patients with access to the services because they won't necessarily order them or won't know that the patient needs them, and it's always -- also addressd in that section, the fact that a lot of hole -- health plans have physicians and other providers making coverage decisions. If they don't have a good knowledge base of genetics, they won't necessarily make appropriate coverage decisions. So, this is where in the report this recommendation is fitting. So, it's in a provider education and training section. It's not a major part of the report, so we don't go off in a big attorney generalent. It's identified to what is provided as reimbursement. You asked about the commenters health outcome point and that's something we need -- .
That's something we need to think about. Because why are we -- are we -- we training health providers in the huge genomic Era so that they can provide the service improve health outcomes and if we're asking the secretary to provide financial support for the assessments of that link between education and pro-health outcomes, I think we're focussing on the first part, but we're not folk-- focussing on the second part. If can you do outcomes, research that is considered as part of the analysis, the level of training of the healthcare providers and genetics and genomics and how that might be reality -- related to the changes of outcomes of patients and population, et cetera, et cetera, et cetera. Just see or not the committee can somehow pick up the theme of linking all of that stuff with improved health outcomes. That's about what we were responding to. Maybe it's required, a create of way of putting improved health outcomes in the para-- paragraph.
This language in the last paragraph there is supposed to address that. Maybe we need to use the words "improved health outcome." The part where it says the secretary should provide financial support to assess the clinical impact of genetics, action eeks, and training. What is meant there is is it make -- making a difference and improving outcome in maybe we need to state that more directly.
It's the words the clinical impact that was used in place of health outcomes, so, so I think it's redundant to put the clinical impact. What clinical impact means is improved health outcome.
How about get rid of the word clinical to impact of genetic's information and training on improved health outcomes.
That way. That would be the hope.
You specified.
Optimistic.
Or just the impact -- . On outcome.
On health outcome. Yeah.
Does that do it, you think? Can you so it --
I think clinical was okay. was working from -- .
look -- . From the paragraph here. so changes that since then.
Right now, it the also should financial support to assess the of genetics education training health outcome. And then it goes on about competency. Can you probably get of the two after the thereby. And thereby integration --
think we're reaching the saturation point on this recommendation.
Is everybody okay with it?
Can we vote without reed in the quorum?
I can jump in ahead of my role tomorrow if need be. Because we have a recommendation on this one?
Yeah. can scroll it, said, we can see the of it.
we have a motion?
Move approval.
Second. All those favor if can you raise your hand. Any opposed? Recommendation passes unanimously and we can move on in -- to number 9.
Number 9. One more. Okay.
Well, there are some more after that. People shouldn't breathe a sigh quickly.
The other stuff has to do with kind of the body of the report, some technical changes and things like that, so it's not as critical. We can get to that long as time doesn't get to the meet of the -- meat of the recommending as. This last recommending a, number 9, has to do with a little bit of public education, making sure that the public has reliable, accurate trust worthy information on how to gather history and genetics technology to make informed decisions with regard to their health care. We received some public comments on this. And one of the comments caution us to make the change here in the second paragraph. The second should leverage HHS resources to develop and make reliable trustworthy information about how to gather and utilize family history, genetics and genetics technology, to guide and promote perform -- informed decision making. We didn't have too many comments on that. Just a few. That was the one change we mada -- made at the task force level. Does anyone have any
As a newcomer reading this, the very first sentence me as being rather confusing. At first, I thought it was talking about reliable and trustworthy information about history. That makes it available the web, making yet sound like it's quite concerning, you know, I don't want my family history on the web. Maybe under we should use is -- use the same phrasing r liable and trusty information of gathering reliable permit -- pertinent history and information about genetic formal ets. Should be something like that. You see my --
Reporter: Think we meant to have a comment after genetics. The gathering history, genetics, genetics technology. They were meant to be two separate thoughts, right?
Pertinent information.
We got it twice there. We have to fix it. What?
I would suggest that we somewhere, we can start and we have a need, the first phrase now, but we should start and let people know where we're going, so patience and consumers need the tools to evaluate health plans, or need to have the information to evaluate health plan benefits and health providers so that they may make the most appropriate and most financially-responsible decisions about themselves and their families. Or just beginning, in order to allow.
Yeah, in order -- .
Patient to consumers and take the bottom phrase and move it to the top.
Yeah.
And we need the to throw genetics in there somewhere, too because -- okay. I see what you did, and then but -- so it's a pretty long sentence.
We haven't fixed it yet. What part do you want to move up?
We can do it hunt's way and see if it's too long of a sentence. But patients and consumers need the genetic information It was not my way. I would start the sentence to allow.
Okay.
To allow, take the last two lines of the existing recommending a. To allow patients and consumers to, valuate health plan benefits and providers. And their families, coma.
All right, are they evaluating the plans and benefitted relates to genetics services?
Well, we'll see the way, the way hunt is -- Hunt is doing it then as a coma, reliable and trustworthy information about family history. It comes in but at the end.
It's my thought this is not really related to choosing the health plan benefits and health providers as much as it is in helping in the medical decision-making for their own care and the care of their family. There are two aspects to this. I think evaluating health plans and health providers is really sort of secondary to really helping to participate in the medical care because genetics is very much this is your choice, what do you want to do, and they, if they're not informed, they can't participate in the process as effectively.
But it does bring in the point, tying it back to coverage and reimbursement because some plans may provide coverage, some may not, and that's rel than the relevant, therefore, to the choice of plan a and plan b.
Can we add words clinically appropriate to make it clinically appropriate and financially responsible decisions. So that ties into the medical side. It's always a balance, right?
What was your definition of financially possible -- responsible?
I think each family has to determine, you know, do they have the means to pay for something, you know, if they'ra -- in a health plan with a huge deductible, is that the kind of thing they want to be in, they want a $10co pay. That's what that were getting at. Within your own personal financial resources, what is financially responsible for you. As a consumers -- consumer.
I guess my problem with that working in a public mel -- health agency financially responsible to us is societal, financial responsibility versus personal financial responsibility. I didn't know what you were qualifying it as.
You mean financially seasonably?
we just say the most appropriate clinical and financial decisions for thens and their families.
How about the most appropriate decision. The most a prone action appropriate decision involves all of the above. Clinical. The most appropriate decision.
Can we add the samecoma after Indiscernible ]
Is this now getting redundant. What is the difference, I missed it. What is the difference between the second paragraph and the first?
The first bear paragraph is sort of --
why are they separated as two?
They don't have to be. We can mush them together. The first paragraph as says patients need access to information and the second is what the secretary can do to help get them information.
If that's all you're trying to say, can you say the secretary can leverage HHS resources to develop and make widely available, reliable and trustworthy information or such information, refers to the previous sentence. Otherwise you're repeating the same words. Two sentences in a row.
Making such information widely available.
Sounds good.
Tom should leverage HHS resources should mean. If you look at recommendation eight, should provide financial support for assessment. Asking happens hhs to, I mean leveraging hh -- HHS sources, somehow implies that we have all of these resources and we move things from here to there. It's that image that is, I'm out in sure what -- who cam up with that word. Aren't we asking the secretaries to do something to develop and make it widely available or work.
To take out.
And -- I think leveraging means something different. What it means is won't the secretary to invest some mean, so it could be, um, you know, that you get more leveraging to me means you get more than the money you invest, but there are strategies where you are going to get more out of it than just putting the money in and getting a product out.
Can we say just make such information widely available and then just come to the on federal government website and other appropriate mechanisms and take out everything?
Why don't we take out development you don't develop such information through the website, do you necessarily.
Well, you make it available.
Just ad-- have make it available.
Leverage resources to make such information available -- .
No, I think it does need to be developed. You have to develop a conscience to put
To develop should --
But you don't develop such information necessarily. I mean it's -- sure you do. You develop content to put on a web sea, even if you're just pulling stuff from the literature. You have to develop the content and put it together in such a way you can post it to a website.
And if it's going to be evidence-based or a research component to check theivaldity of the information before -- the validity of the information before you put it on.
Remember, the surgeon history, to. was developed, too.
All right, how does it look? Any other?
Why don't we take a moment to read through it.
Could we accept the changes so we can see it all as is written or not?
We need a sin them for information.
Because you're referring to it again, right? I think it should stay as information. You're saying such information refers back to
In this isn't meant to be a best-seller but understandable. Can you say they need reliable and trustworthy information -- about family history, about gathering family history, genetics and genetic technology.
Suzanne, don't touch it.
Okay. You don't need the pert -- pertinent information about gather -- yeah.
Consider changing the order so that it's trustworthy information about genetics, genetic technologies and gathering and utilizing. Just change the order.
Don't they really need trustworthy guidance about gathering this information opposed to --
I agree with what Hunt said about moving the genetic technology.
We ask -- can say trustworthy information about genetic technology and gathering and utilizing -- genetics pick up. YeahJust -- send, over here again.
I keep hearing it over there.
bouncing off the wall.
To start it with to -- to allow, I think, frames it in a way that gives yet a paternalism I don't think we need, so if we could sigh say order for patients and consumers to evaluate plans and benefits to make the most appropriate and take out that so that they. It would be a less.
Maybe with that change we can look at it one more time and see if this does about what we can expect it to do at 5:00 in the afternoon.
In order to utilize family history, you have to gather. Gathering in.
We must
Shows that it's a of the surgeon general's family history. Um, initiatives we leave it in there for that. I have no strong opinion as -- at all.
I think from a
Utilizing if we're going to do it. About genetic technology, a timely history.
Let's read it and see if we can't get get to a promotion.
You raise -- had a concern family history. I think in this context, though, it's differently worded search -- such that it's not saying the family histories are going to be individual family histories published on the website. I don't know.
Okay, so if Suzanne will put her hands in her lap. Don't touch the keyboard. Let people read it and see if we're getting close.
The micro phone.
Yes.
I think you need a comma after family history to set all that aside.
With that comna -- comma, I prove -- move approval.
Second.
Okay. All in favor? Any opposed? Okay, we are unanimous in accepting that recommendation. Soldierd through all nine recommendations. Signed what, else do you have for us?
Can I ask that at the end of the day, I know this is hard on staff, but maybe if this be printed up for us so we can look at it one more time tomorrow on a piece of paper.
A clean version of the recommending as.
Did any staff hear that request?
Okay, I don't know if you want us to do this. There were really some --'s couple of minor and one more significant change to the body of the report that we made made at the task force level in response to public comments. I don't know if you want us to go through those no -- now or
I think we have been in the spirit of accepting task force's good work on behalf of the committee as summarized here. They don't look too substantial to my eye, unless anyone would like to discuss them. You want to give a brief outline of what the areas were so that everybody knows what they were?
Sure, the first has to do with revising the introduction sec of the report, and we rephrased the sentencey to so that yet now reads, can you look at the blue part in your paper there. Why I won't read it out loud. It addresses the issue of reimbursement levels for covered tests. Move approval.
I'm not sure we need to vote on this.
I think we do. It's a final, the final -- unless we're going to have a vote on the final document.
And I don't believe we are.
Yeah, so why don't we just.
Okay. There's been a motion to accept that change.
Second it. And the second. All in favor? Go oppose? it stands unanimous.
The next wound -- one had to do, we had a section on what is genetic genomic test and technologies what, are they, and there were a lot of public comments, a lot of public comments about that fearing was a definition, it's too long and too confusing, so our task force recommendations was to indicate that really the text is meant to be a description rather than any kind of hardened fast definition. A discussion.
Any on that point from around the table?
We've all had this very long definition of genetic tests and partly it was historical we were using the definition that had been developd two committees ago. Have we already buried it, Suzanne or Sarah, the have we waivered from that definition of a genetic test already? Reporter: Think we spent some time discussing that and at least it was modified to also include genomic tests.
Okay. So then
Okay.
That's fine.
Any further comments on this change? the last, we have already talked about, which is specifyd, to be consistent when we talk about providers, the is the same throughout the report.
Why don't we just for formality sake, I'll move to accept those changes as well.
All in favor of accepting those. Any oppose. Okay w that, -- .
Done.
Done?
Fenite.
Well, I'm sure I speak for our role chairman and thanking Cindy and the task force and staff, especially Suzanne for an extraordinary amount of work in getting this document done and Shepherdd through both public comments and our own attention to it. As is traditional, Dr. McCabe always has something to add.
We had said this, according to the schedule, these changes were going to be made and then we were going to approve it. You all were going approve Jill -- it in October. The question is does the committee need to see it again or is it approved as it is now and could it move forward as -- at this point rather than waiting another quite a few months? I think we have to go through and still, we're in the process of incorporating technical changes and comments that were made. So, -- .
But though were, I lookedality those. Those are gram mar, and you know, that we sped -- spelled, it was tech instead of pax for a lawsuit and some things like that. I trust that the staff could do that.
Right, and that's the spirit of the timeline that Cindy propiece -- proposed to us earlier, that there would be final minor visions through the summer and then in the fall, it would be transmitd and there isn't a step, at lost -- least not written, as they come back before this committee.
Okay, so it will be transmitted without coming to the committee. I just
Well, the committee will get one last chance by e-mail to review the entire text of the report once we have done -- gone through all the public comments. But that will be done by e-mail, probably.
And any guess of a schedule on that?
I'm sorry? Any guess at a schedule on that?
We'll probably have a final draft ready by the end of the summer, possibly earlier, and we hope that the will be approved by, before the next meeting in October.
And so that e-mail will include a letter to the secretary that will involve[ Indiscernible ]
Okay. The report will also, what is not in the report now, um s an executive summary and that will be preparing an schist summary, in addition to making some other technical changes to the report. But the committee will have an opportunity to have one last look at the entire thing before it gets transmitted to the secretary the
Yeah, I just think that we belabored this, and I'm sure we could worth Smith it for -- word Smith it for another 18 months, but I think it's important it move forward as quickly as possible.
This sure is done. Right. Mr. Chairman, or sear a are there -- on Sarah, are that -- there any final announcements before we adjourn for the day? I believe we're done.
We have to talk about dinner. We need to get the information on dinner.
Actually, more than, that was wondering if you would like to go over what decisions you made today so that would mean, and you might tell everybody about can -- Hunt tomorrow and you tomorrow, and then that would be -- would free Hunt up from having to do this tomorrow. You know, the three things we did today and what we -- we have them know what? We have them wren out -- .
Good.
Was just going to grab my sheet -- notes, though, although I do believe you. [OVERLAPPING SPEAKERS]
Give us a moment.
Dane -- donor? As usual, Sarah is way ahead of us.
Yes, members who are joining us for dinner tonight should meet in the lobby at 6:40. We're having dinner at 7:00. Well, would you like to go earlier? We can certainly see to that. If so, when? 5:00 in 5:30, I mean, 6:00? 6:00.
That's a local person on the earlier the better.
Okay. We'll meet at in the lobby.
And then, far as tomorrow, I, our friend Hunt will take the chair tomorrow. I have to be away with an unavoidable conflict and I have to attend to that. I apologize to the committee. But anyway, thanks, Hunt's well-prepared, we have gone all over this and you're in traffic hands. Besides, can you take a sigh of relief so you don't have to deal with the crazy guy W. that, will with that, the summary on genetic discrimination, copies of the DVD are available to the committee. Can you get it and copies will be made available to the public on the website. As you key -- see, continue to monitor developments of Representatives, make completion of public comments, DVD -- make compilation of public comments, DVD and public announcement and I have already said that. That's good. Um, let's make sure -- . Is this broadly available including giving it to Indiscernible ] The big are the's office specifically -- .
If she asks. She does.
She does. She got it.
He -- she already has the copy because she asked.
Right. And she asked for it and we gave it to her. We were clear on that. Number two, large pop studies. Yes, we -- review of -- report of NEH. We're asked to read that report carefully. Well, this is the charge to the task force. But -- yes, the rest of the committee should
The committee is supposed to read the report.
Yeah.
Okay, now from that, let's go to the task force. They have to read the report, to, and identify other policies that need to be addressed and recommended the process for commenting them, plan a public consultation meeting if possible with the general public and the scientific community. You left out the scientific community.
That's in the second, third bullet.
Third -- third bullet, okay, about the U.S. idea of you[ Indiscernible ] Sing such much is a study. An addendum to that the challenge the committee's going to have is how do you in fact ask a public comment on something nobody understands. There is going to be -- to need to be be, the task force is going to take a good, hard look at explaining what this thing is and quiet making that a part of the announcements. Is there any sort of summary, executive summary kind of thing of that report?
Yes, I believe there is. If I don't -- I haven't read it for awhile, but I believe there is an executive summary.
Okay. Then plan a public consultation or meetings in October to gather . In the scientific community. Yeah, I think the idea would be, though, at least the a sumtion is you need to think about whether they go together or separate.
Uh. I want to be careful about the administrative burden of trying to do separate things. You might determine you can't do them together but it's something the committee needs to think about. This is one where I would encourage the committee to move forward deliberately opposed to expeditiously. of all, I there are the resources you can rently in the hand in the hand to engage much is a study. I think that the uk ran into problems where the public was not prepared when they tried to roll it out, so I think there is an opportunity for this one to be deliberate and you may save time in the long run by, by being delivered -- deliberate.
Good. Then I want to make sure I didn't miss anything. Direct to consumer marking, we're going to send a letter back to the secretary describing we're pleased with the initiatives ongoing, that there has been movement there. We're going to comment -- commend the agency's efforts to respond and recommend allegations of the public's impact to marking, recommend enhanced public understanding, offer via directly to consumers including the issue. We're asking the secretary to think about, this recommending increased efforts to enhance public education to excess including the issue of the general consumer alert and then urging the FDA to consider the internet-informed labeling and those are the things I had in my summary. Did we miss anything? And then we did the stuff -- it's been an extremely productive day. You should feel good about yourselves. Good job. you all very much. Tomorrow morning, what time? 8:30? And should be on time or oh, my god, the woes that will begall -- befall you.