tv Politics and Public Policy Today CSPAN March 21, 2016 9:00am-11:01am EDT
thats that also now become part of the norm the way we want to fund research. >> thank you very much. let me talk about taxpayers provide more than about $30 billion annually for nih's research. dr. collins, you say nih fosters innovation, leads to effective ways to treat complex medical conditions. yet in so many cases, taxpayer-funded research leads to drugs that are sold back to the taxpayers at exorbitant prices. example, ucla led to a drug to treat prostate cancer.
the drug costs patients $129,000. the same cost for patients in other countries about a third of that amount. i realize the pharmaceutical companies invest their researches, they bring a new drug to market, they should profit from that innovation, but why are the u.s. patients getti getting gauged for drugs. can you better explain why u.s. taxpayers are paying for biomedical research at the front end and paying exorbitant prices at the back end? i'll just say that 50 of my colleagues and myself sent a letter to you and secretary burwell requesting that they write when tax-pair funded research leads to patent product not available to the public on
reasonable terms? what are reasonable terms? a drug shouldn't cost $129,000 for people to get access to it. >> i know this is a topic of great interest, and while it should be and my heart goes out as all of us do to patients who are in need of a therapeutic which is outside of their financial means to be able to gain access to. that ought to be the thing that drives us trying to come up with better solutions. i would say with regard to marchant rights, we read the letter carefully. you saw the response from secretary burwell. nih can march in if we don't have reasonable terms. >> what is a reasonable term? >> that is very much where it gets cowan to the nitty-gritty. we have looked at that situation several times in the past. have not felt we reached reasonable terms, but we are open to considering that on a case by case basis and will be glad to do that with other products brought forward for our consideration.
we get it that this is a serious issue. >> let's have further conversations. i've gone over my time. thank you. >> next operating on the order of rible, mr. harris. >> thank you very much. good to see all of you again. it was a great visit last month up to see what's going on. meeting with dr. rosenberg and the patients reminded me of why i went into medicine. and what am i doing in politics? let me ask a couple of questions. first of all, with regards to strategic plan, dr. collins, you mentioned one of the ten things on your predictions is hiv vaccine. part of the -- part of what is addressed is that nonstatutory set aside.
vaccine or vaccines account for less than $400 million out of a total of what i assume is now only $3 billion. my question is specific with the additional $2 billion that was appropriated last year, how much of that went into the vaccine development? since that really is, because you address the cost, if you can bring that down to zero, but the only way to bring it down to zero really is we have to develop a vaccine. you're only spending about 15% of the budget vaccine hiv. so is it, the additional monies, how much went to vaccine and how much went to nonvaccine hiv programs? >> i appreciate the question. you and i talked about this issue. it's helpful to have your perspective and that of other members. i'm glad you mentioned the strategic plan. this was something congress asked us for. we put it forward in a way we thought could be helpful in terms of defining how we set
priorities. please have a look if you have not looked at it previously. with regard to hiv aids, we have decided it is time, just as you have said, to focus on the most important priorities to end this epidemic. the vaccine is right at the top of that list. there are other things on that list, as well. as a result, we have looked at our hiv aids portfolio this year and identified projects which are going to come back for competing renewable which we no longer think fit into those highest priorities, four of them. as a result the dollars which would have gone renewing those programs has become open for competition for things that are high priority. vaccine is very much on that list. we will in the course of probably the next couple of weeks announce how we are moving 66 million out of areas which were good science but they don't seem to be high priority for hiv aids, into the areas that are. a substantial fraction of that is going to go to vaccine preparation. >> i would urge you do that. there is a line, $100 million a
year for basic behavioral and social science research. honestly, i would much rather see the $100 million going to accelerating the development of that hiv vaccine. i just returned from kenya around lake victoria. look, the solution is we have to vaccine night people in the end. i'm becoming convinced you have treatment penetration of only 50%. you can -- until we can vaccinate with other infectious diseases we are not going to cure it. the chairman of the full committee left already. mentioned marijuana. there is a -- samsah survey. you can look at the increased use of marijuana. it's interesting what happened in colorado between the 2002/2003 survey for 18 and
25-year-olds and 2013 to 2014 survey for marijuana use in the past month. it went from 21% to 30%. the national use in that age group went from 17% to 19%. clearly, i think what happened in colorado is you legalized the drug. there's a lot of misinformation out there about what happened when you legalized the drug. honestly, it changed from 21% to 31% use in a highly vulnerable population of concern to me. is it of concern to you? >> not me. >> i'll tell you, the advocates for legalization say we shouldn't be concerned about the
usage figures. iminterested in what your opinion is. >> we are very concerned and we are particularly concerned by the very high rates of use of marijuana, not just 18 to 25 but on teenagers 12 to 18 years of age, and colorado has the highest rates in the whole country of the use of marijuana in that age bracket. we are particularly concerned because marijuana is a cannibinode and effects the synaps. they affect you until you are in your 20s. when you are smoking marijuana, you are interfering with these very carefully orchestrated processes by which biology, nature ensures our brain develops to the most complex organ.
specifically because of the potential development adverse effects that exposure may have in young people. >> thank you very much. i yield back. >> thank you very much. the chair is struggling to enforce the clock even on himself, which i think shows how much interest there is here. i would ask members to try and do the best they can. with that, i go to my good friend the gentleman from pennsylvania whatever questions he cares to pose. >> i resemble that remark, mr. chairman. you said that right before you came to me. let me thank dr. collins and our guests. i authored some language that created the working group on neuroscience. a long with the national science foundation co-chair. simultaneous to this hearing, the national science foundation is in another side of the capitol giving a hearing. these two things are intertwined. that is the science and work nih together is how we are going to
ma make, disrupt the progress. we have another bill working on energy. i know nih is at the very engaged in this. what i'm interested in now, i see the numbers for this queer's budget. if you could talk to the committee for a minute about what the 12 year cost is on the brain initiative so we can see it in totality. i spent time out at stanford with dr. newsome and some of his people. i think it would be helpful this is, i know we say the administration's initiative. in truth it is a partnership between the congress and the administration. i think we need to make sure that we have a good understanding of how the road, how the runway is out in front of us, which is what we want to
achieve. >> i appreciate the question because this is certainly an area of great excitement. how do we figure out how those circuits in the brain do what they do. that is a perfect depiction showing the ways in which all the wiring works in the normal brain. that's taken on a perfectly healthy individual who is quite awake at the time this is done. new technologies we didn't have the ability to do until fairly recently. the brain initiative was, in fact, conceived of as an effort that would result in a lot of technology development in order to be able to do these measurements on circuits and realtime in the human brain. the overall budget for this was to ramp up beginning in the first year fy-14 at $46 million then ramping up to $400 million a year which we hope to get to in the next year or two. the overall budget over 12 years going from fy-14 to fy-25 is
$4.5 billion in the proposal that was put together. this was an effort that was led by corey barredman of rockefeller and bill newsome of stanfo stanford, a dream team. that blueprint is out there and worth studying. and we'll revisit it. we are ahead our schedule. >> thank you. let me say the chairman and our ranking member along with members of the committee, we were pleased with the $2 billion increase last year. i know that the chairman made some comments about the administration's proposal and where we are on that. i would join in the chairman's view that that is not acceptable. i want to put this in some context for a good part of the years that we've been in afghanistan, we've been spending about $2 billion a week on average.
when we think about all the lives that are affected by diseases and disorders you are seeking to cure, 2 billion increase, even though it's very significant and there was some heavy lifting, in perspective, this is a nation that can do more in terms of research and science and medicine that will make a difference for tens of millions of americans. it's just a matter of political will. the $4 billion is where we have to get to. if you could, i will conclude my last comment. zika virus, is there anything more we need to help new that regard? thank you, mr. chairman. i yield back. >> thank you very much for that question. there is something that the congress can do. as you know, the president asked for a $1.8 billion supplement to enable us being the nih, cdc,
fda and others, a variety of other agencies, but we really do need that money because right now, i've already started a major program in zika research, particularly towards the development of a zika vaccine. i'm doing that with no new funds. that's not going to last very long. in order to prepare for the next phase of studies that would be the efficacy studies of a vaccine, we plan to go into a phase one trial for safety by the end of the summer, early fall. we could not take it beyond that if we do not have the money. we do need it. >> now the gentle lady from alabama. >> thank you, mr. chairman. dr. collins, as a mother of two young children, i'm very interested in the health of the youth of our nation and specifically, it's come to my attention that nih has spent an estimated $1.5 billion on the
national children's study in ci since 2000 this effort was halted in 2014 based on your recommendation. nih conducted a shutdown of the children's study in fy-215 and fy-216. last year the omnibus provided $265 million for the children's study, the president's fy-17 budget requests level funding for this program. in your fy-17 budget justification, you mentioned nih will use these funds on a new program, the environmental influences on child health outcomes, echo which is to study a wide range of pediatric conditions. it also states the echo program is designed to take advantage of existing resources left over from the now-defunct children's study. so what i want to know is can
you describe the results we gained from the $1.5 billion we spent on the entirety of the children's study, if you'll start there, then i'll have follow-up questions. >> i appreciate your raising the issue. this has been an area of intense interest for myself and my colleagues. national children's study originally authorized by the congress 15 years ago. over the course of time developed a number of features about its design that began to look as if they had not kept up with the technology developments and other opportunities. it was painful to look at this a couple of years ago and conclude that we needed a different approach, that we didn't want to continue to expand a program that cheerily had deficiencies. it was not going to be as successful as we had once hoped. that was the reason with much advice from experts we decided it was time to close down the national children's study and come up with another strategy. there are many samples and data available from the individuals
who were enrolled in the national children's study, although it was a modest new. it was pilot programs. those were available to researches who were going through them to see what data could be derived. how can we achieve the same goals understanding what are the environmental influences on children's health? how can we get those answers now in 2016 in ways we couldn't have imagined possible 15 years ago? >> explain to us how that investment will care why i over into echo? specifically as you can. what can we take from all of that investment and know that now with this additional money, the $165 million that is requested for fy-17, how can we know that $1.5 billion is not time and money wasted? >> it's not time and money wasted in the sense there are these pilot efforts that were run that have research samples available that people can study
which will help us guide what kind of decisions we want to make with the new program echo and what environmental exposures will be most important. echo is focused, in fact, on four areas which seem to be particularly xwe lly compelling we learned, asthma, obesity, pre and post nasal outcomes and autism. in a way i think will be more efficient, result in more meaningful data, it will get there quicker and will involve many more data access opportunities for researchers around the country who have good ideas how to learn from these, how we can do a wetter job keeping our children healthy. >> and the report that was required in the language in the omnibus said that you should submit a spending plan on the next phase of the study no later than 90 days at the enactment of this act. where are we on that? can you give us some highlights?
>> i would be glad to. we are planning to submit that report a few days late because we are right now at a very formative place for echo. we are inviting those running cohorts of children where they collected a fair amount of data to join this effort and we will make it possible for them to have additional laboratory measures added to what they were already doing and create a whole greater than the sum of the parts with 70,000, 80,000 individuals, children whose follow-up information we can add further data. that is going to be, i think, something we'll learn about soon. applications are due on april 15th for the cohorts to come in and say they want to be part of it we hear noise here about that. the process for recruiting a director for this effort and have an exciting candidate lined up. there will be a lot to report howwill be spending this money. we are grateful to the congress that this is something you want to continue and provide
resources for. we've gone through a difficult transition here, what we are on the path to do will be more successful than i would have thought possible five years ago. >> thank you. i yield back. >> thank you. i will go to my good friend the gentle lady from california. >> thank you, mr. chairman. i would like to follow up on the question of miss robey with regard to echo. i think you said you are putting together that ten-year plan, and that will include, i assume milestones and estimates in that plan. when do you expect that the recommended advisory panel with outside experts to be established? >> at the moment the plan is for a seven-year effort. we want to see how we do in seven years. expanding to ten would be the hope. it should continue to yield up
new information as we follow these children over time. the advisory committee is being put together. it will be formed as a working group of our council of counsels. you might guess the environmental health sciences institute, child health institute and others. we need to have this positioned in a place where we have advice from expertise across many different disciplines. that's where our council of counsels comes in and we'll issue an advisory planl for echo. >> the congressional justification mentions research activities for fy-15. are these the existing cohorts being used going forward or are you identifying cohorts to be used in the initiative. i want to throw in one more question. will the array of cohorts include broad population samples
and measures specifically designed to compare the study cohorts to know national samples such as national health and nutrition combination survey? >> great questions. in terms of what cohorts will be involved, we decided this was best handled as a competition. we put out a funding opportunity announcement and are waiting for april 15th to come to see who comes in to apply and take part. we expect. these cohorts will be very interested in taking part because it gives a chance for their work to become more meaningful. we will want to see that happen. certainly, we will want to take full advantage of the national study that has much data in it about environmental exposures and a variety of other measures of health and nutrition to do comparisons with what we see in these cohorts. it's wonderful we have that foundation with other studies to do this with. there is one other aspect of echo that deserves mention, that is an effort to set up in tt idea states, the states that
currently do not have a research-intensive university setting, pediatric research network. there are so many things we could be doing in terms of pediatric clinical research in those states, but we are not currently set up to do so. this is a proposal to build upon the expertise that is happening in those states through other programs. and enhance our ability to understand what are the influences in children's health we don't know about yet. >> one final question in this area. your congressional also states the ncs-a will be assessed starting fy-17 and this could drive its future direction significantly. when will that assessment begin and who will be involved in doing it? >> again, we'll very much count on our advisory group that is being put together. fy-17 we will have these cohorts funded and assembled together. there will need to be a
coordinating center to make sure this is working in the most effective and comprehensive way. fy-17 will be the point which we'll have an assessment to see if this model is working and producing all the data we believe it should. >> thank you. >> the gentleman from tennessee my good friend m. >> it's tremendous we see the great cooperation and efforts made in this critical subcommittee. i'm privileged to be part of it. dr. collins, let me 2 you and your distinguished panel again. your efforts in combatting the mal maladies which mays us on the health front are difficult. again, i thank you for your assessments and continued efforts. i've got a three-part question which i'll read through in the
interest of time. dr. collins, i would like to take a moment to address precision medicine initiative. my first question is regarding the direct volunteer portion of the research cohort. as you know, vanderbilt university is playing a leading role piloting the direct volunteer portion of the research cohort. can you elaborate further on how that pilot program will inform the initiative going forward? the second part of my question is regarding the approaches nih is using for recruiting and retaining people in the pmi. while i'm pleased to see nih adopting novel practices, including the use of social media to attract these volunteers, i would like for you to address some concerns that have been presented to me by the scientific community. specifically, can you address nih plans to interpret and understand inherent biasses the approach presents, particularly given that many people do not use social media at all?
finally, is the nih working with the nchs or other federal partners that fund or conduct large representative surveys to understand the bias or pmi cohort? >> great trio of questions. let me answer quickly. we are under a time constraint. precision medicine and initiative is getting launched this year. many of us are working 24/7 to get this up and going and are very excited about its potential. the goal is to by 2019 enroll a million americans as full participants in a study that will collect information from them, including electronic health records, laboratory data, genome sequences, their own reports of medical experiences, and allow us with a large scale longitudinal study understand the factors in health diseases. we never had anything like this before. everybody is excited about the
kind of inference we can learn from this. vanderbilt is a major part of our first launch here. they just received an award in partnership with google which is called verily to set up a pilot effort to recruit direct volunteers. i say pilot intentionally. we need to learn more about how to do this. your concerns about social media being a biased way of involving people have certainly been apparent to us. we don't want to depend solely on that. at the same time with a partner like google and vanderbilt working together, we do believe we should be enable a few months to learn more about what is it that volunteers are interested in, what makes it appealing to them to join this effort, what things are they turned off by, we want to get that clear before we launch. admittedly, we have two different ways people can come into this. one is direct volunteer route open to any american starting
this summer. also we are asking health provider organizations that are running large cohorts to come in as our partners. they already have lots of access to patients and lots of information about them. that will be a very substantial part of the effort. that won't depend on any social media concerns. awful these individuals will need to be asked their permission. if they decide to consent, they will become participants in this historic undertaking. we are also reaching out to traditionally underrepresented groups by working through community health centers with our partners in hrs to make sure those individuals have a chance to take part. we are interested in working with nchs and haynes as we get into this to be sure the data we collect will be generalizable to the population. we don't want a set of individuals different than the population at-large that we can't do that generalizing. that will be important to talk about with those experts which
we have been doing. i'm excited about this. this is really something many of us have dreamed about for more than a decade. we appreciate congress' support getting it started this year, and the appreciation for the consideration of expanding it even further next year as we launch this thing. >> my time has expire pd. i yield back. >> thank you. we go to my good friend from pennsylvania, mr. dent. >> thanks for having us up at nih a few weeks ago i. enjoyed that opportunity. dr. collins, i've been very involved in working on obviously the fight against cancer, but including encouraging screening for colorectal cancer. you'll see those folks up on the hill today in their blue shirts. nih, nci cancer institute is pursuing new cancer research to prevent, diagnose and treat, what are some promising areas
cancer research colorectal? >> i'm going to turn to my colleague acting director of nci to answer your question. >> thank you very much, mr. dent. as you probably are aware, march is colorectal cancer awareness month. part of the vice president's moon shot initiative involves screening which you were involved in, to try to use molecular analysis in fluids for making this more realistic so that we can have higher up take of colorectal cancer screening. one of the big problems with screening is many people don't follow the screening guidelines. it's really important to try to implement what we already know works while we are also doing research to develop better tests and more specific tests. i can report to you that the incidents of colorectal cancer is going down as is the
mortality as a result of the screening we have to date. >> thank you for that answer. also move to the issue of superbugs. what's the latest information on nih working with the cdc creating and curing these antibiotic resistant bacteria. what advancements have been made in this effort? any results you can share? >> thank you for that question. the nih is part of a multiagency approach towards the addressing of the problem of anti-microbial resistance which comes from the white house, which had an executive order and a combatting anti-microbial resistant bacterial initiative which the nih is a major part. cdc is involved in surveillance and detection and providing the guidelines for the use of antibiotics. the nih component is the
research component of that. in that regard we are responsible for determining at the molecular level the basis of the emergence of resistants, number one. number two, to do early screening for new types of antibiotics. for example, there has been recently the texobactrin antibiotic which is a soil antibiotic which will open up the door to a whole new class of antibiotics that do not have any resistants to gram positive microorganisms. in addition, we have a clinical network which we tacked on to the clinical networks that we built years ago for hiv aids to test promising compounds, and then finally, the most important issue about all of this is diagnosis. in order to really circumvent the issue of anti-microbial
resistant, you have to make the dig sis diagnosis on the spot. you have to determine if you have a viral or bacterial infection. those are the biggest offenders of prescribing antibiotics for a disease that isn't a disease. also in a particular point of care kit to be able to determine exactly what the resistance profile is. you put all of those together, together with the cdc and that is a rather comprehensive program. we are part of the program of the prize. we have a $20 million prides we the nih is sharing, $10 million of that with the biomedical advance research development authority at the department level to develop a sensitive diagnos diagnostic to do what i described.
>> i know the nih funding cliff through mandatory spending has been raised. we are all concerned about it. i am concerned there is a decrease in discretionary funding. last year we did the $2 billion increase in discretionary funding. how will nih be impacted if the authorizers don't have to provide mandatory funding? >> it would be devastating if we were to lose $1 billion. the chair asked the same question at the outset of the hearing. i painted a gloomy picture because it would be devastating. we would lose a thousand grants that would have been supported,
would have done terrible damage to the momentum started here in fy-16 thanks to congress. it would be a terrible step in the wrong direction comparable only to the sequester in terms of the harm it might do. >> that was a sneaky way -- because you knew i would like that question. very smart. >> anything to suck up to the chairman. >> next go to my good friend from idaho mr. simpson. >> thank you, mr. chairman. thank you all for being here today. thanks for hosting us out to nih a couple of weeks ago. i always come back -- i've been out there several times over the years i've been in congress, i come back both amazed and inspired. it almost makes me feel guilty for you coming up here to testify. you have more important things to do than testify before this committee. getting out what you do and what nih does is part of what's necessary. as we took a tour, you took us
around and visited some patients, a young man and his wife, young man had melanoma. you talked to us about the treatment he was getting and so forth and so on and what you were trying to accomplish. i can't remember which member it was. asked a pretty simple question that i would like you to respond to for the record. and that was what did the government shutdown do to you? most people see it visibly, gee, you didn't get into the national park or something like that. okay. go next week. you traveled long ways, but it's not life threatening. what did the government shutdown do to you and happens if that occurs again,ing regardless whose fault it is?
we could argue that now till the cows come home. >> i've been at nih for 26 years. those 16 days were the darkest i can recall going through. the laboratories where graduate students and post doctorate fellows and other talented scientists working were all dark. we had to tell everybody to go home. they were under threat of criminal prosecution if they came on to the campus. experiments that had been set up and needed to go for several weeks were ruined and had to be started all over again, if they got started at all. but our clinical center, our largest research hospital in the world, also very much affected by this. we were allowed to continue the care of patients who were already there but not allowed to admit any new patients during those 16 days. those were people who planned to come to nih. we are the house of hope for people where medical research is needed because there is no real answer for what afflicts them.
we had to turn them away, hundreds of them. i personally had to oversee that. the only exception was people in imminent danger of death, we had to have very high level of approval to do that. people couldn't understand this. how could this be that something like this could have happened? i appreciate you asking the question. i hope and pray we never go back to that situation again. it was very hard to preside over that dark 16-day period and feel good about the government. >> i appreciate that answer. because it's the real effects of what happen that people don't see out there as i said, they can see the obvious trash didn't get picked up on the way to mount vernon or by about the park service or whatever. they don't think about the life-threatening implications of some of these decisions we make that we make too lightheartedly,
frankly. so i appreciate that answer. i could ask about a lot of the other stuff you've got going on, but i'm not smart enough to ask it. i appreciate this strategic plan you've given and what i would encourage members to do is look at the last page. a few bold predictions for america's future. interesting. if you think of the work being done at nih, the best kept secret in america and best kept secret in washington. that's the good news and bad news. we need to get the american people to understand what goes on at nih and how much of the research is done at universities and they are done and funded by the taxpayers. so they know what they are getting in their investment. we are politicians. we respond to the public. when the public demands that we invest in these types of things, that's when it happens. i appreciate you all being here today. sorry i wasted your time instead of doing the important things
you do. thank you. >> i don't think my friend wasted anybody's time. i think that is something that needed to be heard broadly. i appreciate him doing that. with the consent of the committee, we are going to move to three minutes to try and give as many people as possible an opportunity to go. but not before mr. ridge gets his full five. you finish out the first order of business. second round we move to three minutes. you get five. >> thank you, mr. chairman. i regret i wasn't able to be here at the start. what is in another hearing. dr. collins and the full panel, thank you for being here. we just really appreciate the good work that you do. i have a little window into growing old because i've been blessed. my two parents are doing well at 93 and 88. i speak to them every week. there is a sad part though because they will generally take me through some of my childhood
friends' parents i knew growing up and walk through that so many of them have alzheimer's. i knew them growing up. that is my little window into this profound challenge. we've done a real good job lengthening life but the quality of life side is lagging a bit. as it relates to alzheimer's, and i don't have all the quantitative data i want. i'm kind of working in that direction. i think that we increased the funding sharply on a bipartisan basis which is a real win. i wonder and wrestle with this that even though we are in a great fiscal stress and that has my full attention, it seems to me that this particular area warrants sharply increased funding, like this is a major
national priority for a host of reasons. and some of them in all candor are economic. just the fact we can get a hold of this. would you comment on that please? also, how much funding could we, in a perfect world if you could have more, at some point you get diminishing returns. you can't put it all to good use. you haven't had that problem yet but how much do you think could you absorb and isle leverage the dollar and get the most out of it? i want to give you time to respond. >> i'm going to ask dr. hotus is our lead on alzheimer's to answer the question. >> thank you for the question. it's certainly true just about everyone has had their lives touched by loved ones, family members who suffer from alzheimer's disease. the great success of the biomedical enterprise, public health enterprise of increasing life span, projections are there will be more and more of this. it's certainly an area among
many you heard about today in terms 2 of the very direct question, given the level of funding can be wisely used, it's a critical question. it's not enough to have an urgent public health imperative, we have to have confidence in the scientific opportunity behind it. one way to test that has come with the congressional request or requirement of nih to deliver a bypassed budget each year. last year was the first one which asked us to estimate the degree of increased funding that would be needed to maximally pursue an efficient spending in support of research towards the goal and in. we've taken this very seriously. we composed that bypass budget which was released last july for the 2017 budget, we began by convening groups of experts last year. a summit of several hundred national experts to tell us what
the opportunities were, what the priorities were, we translated that into milestones which are available to tell people what it is like in an online data base. this is the real scientific estimate what we could accomplish or increment we could use in fy-17. we knew when that budget was submitted that there was a possibility that accelerated funding could come in 2016. we were not sure, thanking for the money that was forth coming. that money allowed us to carry out the thoughtful plan, accelerating what we proposed could increase funding in 2017 and using it in 2016. in july of this year, we will be fording francis and collins, the fy-18 budget which appropriately calls us to do just what you are asking to account for, what level of research could be done to accomplish just what to ensure that we can have research supported efficiently without any compromise in its quality
with researches available. >> within nih -- i've got about 20 seconds left. there is, i'm sensing here, a true recognition that this, not to the exclusion of other diseases and other things afflicting us, but this particular challenge is getting increased recognition as one that really needs to be addressed. dr. collins, perhaps you can close it out here. >> if i may, i think we are not limited by ideas about interventions that might be successful. we are not limited by talent of scientists all what it from basic to clinical who are really fired up about tackling this disease. so resources are much appreciated. we have nowhere near where we don't know what to do with them. the bypass budget is a great way to see if resources were available what could we do? we could go faster. goodness knows we need to. the cost of this economically,
over 200 billion every year. >> thank you all, thank the chairman for the additional time. >> thank you. we will move to three minutes. it was extraordinarily helpful to this committee to have access to that kind of data in our decision making last year. i encourage you to continue that. as you know, dr. collins, i've got a particular interest in native american issues. just quickly, i know you look at particular populations. not everybody is the same, gender differences, racial differences, all sorts of things. what is the nih doing specifically to address native american health issues? >> we are very concerned about all populations in the u.s. and american indians are a special group both in terms of their history, their culture and their tribal sovereignty which has a major effect in terms of participation and research we
need to be very respectful of and we aim to do that in every day. we actually adjusted, and nih thanks to the leadership of dr. taybak initiated a tribal many council advisory committee to listen carefully what they see as priorities to focus on and engage in them with the specific medicine initiative. and their sensitives they are about, what kind of information is being derived about ancestry, what access to the information will be provided to people outside of the community. as you know, there have been experiences in the past the american indian communities have gone through that causes them to be somewhat less than completely confident that researchers are always working in their best interest. we really need to understand that. in that context, i think we have a number of important programs
that have been ongoing for a while. the strong heart effort looking at heart disease, for instance, in indian country that's been conducted by the heart, lung and blood institute. and on a particular project i recently read about that we are supporting which is aiming to try to deal with high risk pregnancies in the native american community, and particularly providing resources to women early in their pregnancy about how to maintain a situation that will result in a good outcome, with a very impressive outcome of this pilot project that's now been implemented across many different tribes across the u.s. so we are always looking for ways that we can do research that is acceptable and embraced by the community, but very sensitive to the special nature of those concerns in those communities. >> thank you very much. appreciate it very much. in the interest of time, i'll move directly to my good friend the ranking member of the full
committee. >> i'm going to talk very quickly, mr. chairman. first of all, i want to say dr. collins, your seven years of service left an indelible mark and i hope you continue your work because we really appreciate you. thank you. secondly, even the lab rats are all male have been a great laugh-getter at cocktail parties, but it's really series. i hope that will continue because it's unacceptable. third, i appreciate dr. harris' comments. i don't think the majority of people in this country understand the serious impact of marijuana on the brains 12 to 18, 18 to 25, and i do hope you can be aggressive in getting this message out. i thank you, dr. harris. and lastly, my friend, the zika vaccine.
we know the seriousness. i wonder if there are any seconds left whether the zika vaccine, they all come from mosquitos, same areas, will whe vaccine, they all come from mosquitos, same areas, will certainly have an effect on chikungunya and dengue. >> well, thank you for the question mrs. lowy. we have a vaccine for dengue, one that's been approved in mexico and the philippines and brazil. it's not as effective as we'd like it. it's about 67% effective. the nih started in january a phase three trial for dengue in brazil in association with an institute there. chikungunya we have a phase one good vaccine that's safe and that induces a good response. we have had trouble, which i don't think is going to have much more trouble, in getting pharmaceutical partners to come in with us for the advanced
development, i think the zika outbreak has shook the cages because we're having pharmaceutical partners interested in coming in with us with chikungunya and with zika. that's the advantage i have had with zika. i've said publicly that although there are challenges, we need a zika vaccine fundamentally to protect pregnant women because those are the most vulnerable. if you get infected during your pregnancy there's a disturbing percentage of fetal abnormalities. we will start a phase one trial likely in september of 2016 based on the expertise that we have developed literally over a decade or more in working with these vaccines and i want to thank you and the committee for supporting the work we've been doing on our ability to respond rapidly to emerging infectious
diseases. that's what we've done. we have six candidates in queue. the one that's the furthest ahead, we had a meeting three or four days ago with the fda to plot out the face one trial that i mentioned that would start in september and then the transition into a phase two likely by the beginning of 2017. how fast we get an answer will depend on two things -- a, how effective it is and, b, how much infection there is. so paradoxically, if there's still a big outbreak in 2017, we will get an answer more quickly. if things die down, though it will be good for the public health, it may take longer to get an answer but we are very much on top of the vaccine development. >> and i just want to say, mr. chairman, i appreciate your leadership and our ranking member and the whole committee in getting the extra $2 million and appreciate this extraordinary panel and all the work you're doing and i look forward to working with you so
we can say, the chairman of this committee has doubled once again in a bipartisan way money for the national institutes of health because i can't, frankly, think of a more important investment and thank you so much for all the really important work you do in your leadership. let's do it, mr. chairman, we'll go down in history. [ laughter ] thank you. >> are you advocating for my budget or just pressuring me? [ laughter ] >> a bit of both. >> little bit of both. with that we'll go to my good a friend mr. simpson. members are advised that we're at three minutes -- >> they've already started timing and i just barely got -- quick question. the cancer moon shot the president announced in his state of the union which, by the way, i think was great. i support it. republicans don't always criticize everything the president does. i think this is a good start.
it's government wide. i chair the energy and water development subcommittee, the department of energy is going to have a role in this, also. they're getting more and more involved in biological sciences and stuff and when i ask them they say, well, you know, we were originally involved in the biological sciences because of radiation and the cancer caused by radiation from weapons developments and other things over the years. what's the relationship between nih, the department of energy? what are we looking at in the future? what will be that relationship, do you know? >> i'll start by saying there is a task force at the highest level, which was appointed to support this effort across government with the vice president's leadership and that very much includes the department of energy as well as fda, nih, a strong input from nsf and a variety of other parts of the government that are involved here, including
commerce because of ip issues. but i'll turn you to dr. lowy who could tell you something about a direct involvement already ongoing between doe and the cancer institute. >> can you also talk a bit about the medical isotopes with the canadian reactors shutting down, are we going to have access to the medical isotopes that are necessary? >> thank you, dr. simpson. first, with regard to the department of energy, we have initiated very recently three pilot projects with them in cancer research and they will form a key part of the moon shot. and we are continuing to have ongoing extended discussions with people from the department of energy, including secretary moniz about further extending this because largely they have
extraordinary computing power and also machine learning which is able to do things that really can -- that would be extraordinarily helpful in the cancer research area. given the time, let me get back to you for the record in terms of the isotope issue, thank you. >> thank you. with that, we'll go to the ranking member of the subcommittee, my good friend from connecticut. >> thank you, mr. chairman, i'm going to talk fast. on antibiotic research i just came from an a.g. committee hearing. i will say that to you, 70% of antibiotics sold in the rust bought for livestock production. there's industry guidance today that's voluntary through the fda. i don't know what collaboration you have with usda, with fda but it's critical, we should not be in silos here. you talked about 23,000 deaths. if we know what's going on, let's get their research, your research and look at how we can cut that number in half as you said last year, dr. collins,
that we could do. so it truly is unbelievable and it's voluntary. we need to think about guidance -- not guidance, voluntary guidance, we need to think about how we tell people that -- and the pharmaceutical companies in a mandatory way, in my view. let me move to the precision medicine initiative. i'll just cut to the chase. i was alarmed by a "new york times" article that failed to identify personalized treatments for breast cancer patients. dr. lowy, dr. collins, what's the clarity on this issue and guidance to practicing breast cancer physicians or patients? >> thank you very much. i think this area exemplifies both the strengths and the limitations that we have of any
clinical test. you do a clinical test and for some people it's enormously helpful and for other people the results are ambiguous. the genetic tests that we have can be enormously helpful in pointing people with cancer in the right direction in terms of treatment but not for all of them. >> is it accurate in terms of -- the success has been in other areas other than breast cancer. is breast cancer a specific disease that is not responding to pmi or am i -- or is this article off base but help us? >> there have been specific inhibitors, for example, herceptin, which was the first targeted inhibitor was specifically for breast cancer and egf receptor inhibitors so there are specific inhibitors for breast cancer. the problem is that when you get an abnormality, not all of them are clearly actionable and not
all of them will be responsive. >> i would like to continue this conversation and i might ask you to look at the "wall street journal" this week. this is bristol-myers squibb precision medicine. i'd ask you to look at it and tell us what bristol-myers squibb is talking about when we're trying to move in this direction. i've got four seconds left. all i would just say is, dr. fauci, if -- one i want to make sure that any vaccine that we deal with for zika is going to be available and affordable for people. this is the reasonable terms issue. but secondly, i would just offer my view. i think it's critical for us to deal with a supplemental emergency resources in order to address this issue and this problem. you are right, i will tell you
that we are now sending blood products to puerto rico in response to a zika outbreak. what happens when we are looking at a blood sip supply that is potentially going to be difficult or people are not going to understand the safety of a blood supply with regard to zika and what kind of problems that will cause here in the u.s. and let me tell you, american women are not going -- they are going to be outraged if we are not doing something about them and about their ability to be pregnant and bring a child to term. so thank you for the great work you're doing in this area. i have another question but that's okay. [ laughter ] >> i'm not sure that was a question. >> genetically modified mosquitos. genetically modified mosquitos. >> i'll ask the gentlelady to take that one for the record because i want to make sure our remaining two members get an opportunity.
with that, mr. harris, you're recognized for three minutes. >> thank you very much. doctor, let me continue and follow up a bit because the marijuana use and full legalization is a huge issue. it comes before this congress. we have a rider that affects the district of columbia on our appropriations bills usually and let me just -- you were co-author ago 2014 review article in "new england journal of medicine," pretty prestigious medical journal and let me review some of the statistics in it and just confirm that these are still true. with regards to marijuana addiction, although the overall rate is around 9%, if you look at young users or daily users it's higher with young perhaps as high as 17%, daily users 25% to 50%. is that still the state of our knowledge? marijuana dependence, though, can be much higher and depending
upon dash because it depends on other factors as well. it can be twice that, 20% in general use. with regards to the gateway theory because this is controversial, my best understanding is there's some reason to believe in other studies that potentially there is a gateway -- it is a gateway drug but it's not clear whether that's true in humans. is that true or are we developing an understanding that it is a gateway drug to other addictive behavior? >> there is evidence that, yes, marijuana changes the sensitive of the reward centers of the brain to other drug which is provides a means by which you become more vulnerable for addiction. but you cannot necessarily directly translate into humans. the issue in humans is still being investigated. but it's not settled science that it is not a gateway drug in humans? >> all of the epidemiological studies show it is a drug that frequently precedes addiction to other drugs. >> and is associated with or causal. i understand. i did animal research, i understand you can't always extrapolate to humans. finally, which was interesting
to me, when you look at the affect on school-age children and you're not careful in how you control the access to children's school that it impairs critical cognitive function for days after use it was interesting and that was stated in the article. is that a fact? >> that has been replicated by independent investigators. >> so if we don't write the laws carefully and you allow children in school to access to it that critical cognitive functioning can be impaired for days. and this is -- again, this is in the setting where we want to have children go to school and learn and be cognitively functional. from a scientist point of view, would you urge jurisdictions that are looking into fully legalizing marijuana to exert extreme caution in taking that position at this point? >> i basically ask people to look at what the data is telling us. we have seen consistently that the most devastating effects of drugs in our country are from
legal drugs, not illegal. not because they are more dangerous but the legal status makes them more available and more likely to expose more people and explains why we have so many more adverse effects from legalization. so i always say, do you want to have a third legal drug? can we as a nation afford it? >> thank you. i yield back. >> and now for the last question of the day, we go to my good friend, the gentlelady from california. >> dr. fauci, my colleague, congresswoman herrera butler and i have started a new congressional caucus on maternity care to promote optimal birth outcomes for women and to highlight issues like the zika virus that pose a risk to child-bearing women. so we've been following with great interest the world health
organization's finding and council regarding this disease. the committee stressed the urgency for research and development of the zika virus vaccine, which you've talked about earlier. but the who emergency committee also recommended both retrospective and prospective studies of the rates of microcephaly and other neurological disorders in areas known to have had zika transmission but where such clusters have not been observed. so my question is whether or not it's possible that the zika virus has been responsible for cases of microcephaly in the united states over the past three to four decades and has there ever been any tracking of this birth defect to see if there have been clusters or increased incidents of it in the united states? >> that has not -- with regard to retrospective studies but there has been no zika virus in the united states. we know that from doing scannings of what has been in the united states. there has been no zika virus in the united states until it has arrived in south america and the
caribbean. what we have now in the united states is over 190 cases that have been imported, mostly people who have been in the caribbean and south america who were infected there and came back home to the united states. what we haven't had is local outbreaks similar to what we did see a few years ago with with chikungunya in florida. there's a very important surveillance capability which will tell us the negative answer to your question, we haven't had zika in the united states. but will also tell us if and when and, unfortunately, it is probably likely that we will, as the summer comes, see mini-local outbreaks, particularly in the southeastern part, gulf coast states, texas, florida, because the mosquito, which is the major
transmitter, is in that area of the country similar to puerto rico, similar to south america. finally, what we do have in south america are cohort studies to take a look at what the fundamental baseline level of microcephaly is and what the relationship is to the infected people with zika. a study came out -- two studies. one came out a week ago showing that if you looked at zika- infected women who were pregnant and pregnant women who were not infected with zika in brazil, there was a very disturbing 29% of the zika infected women had ultrasound dopplers indicating abnormalities of the feature, which is very disturbing, which is the reason why we feel very compelled to be able to get a vaccine to protect not only the people in south america and the caribbean but, if necessary, if it comes to that, in the united states. >> let me just give you the personal reason and personal
interest in this particular area. my grandson was born with microcephaly. this had to be probably over -- about 12 years ago. as a result of that, both my daughter-in-law and my son took every test imaginable to find out what the cause was, especially since they planned on having other children. and they could find nothing. none of that research. i'm just wondering, we're trying to figure out what possibly could have been the cause. >> there are a number of causes. that's an excellent question. very important question. because people sometimes get the misimpression that microcephaly is only associated with zika. but microcephaly has been around forever. it's associated with something that happens, usually in the first trimester. that can be a viral infection, that could be cmv.
that could be any of a number of viral infections. that can be fetal alcohol syndrome. that could be a variety of things that interfere with the developmental process. usually takes place concentrated in the first 15 to 20 weeks of pregnancy. although, we do know now from a study that even women who get infected in the second and early third trimester can also have abnormalities in the fetus. may not be full-blown microcephaly. the range of abnormalities are disturbing. which gives us fuel to the fire of getting the vaccine. >> another thing to mention is genetics. >> in the days gone past, it was difficult to nail that down. now that we have the ability to look at the genome sequence and many centers are doing that, we're uncovering causes of microcephaly due to dna changes that we didn't know about. that's wonderful. >> thank you very much.
dr. collins, let me begin by thanking you and your colleagues for not only your appearance here today but your accessibility to all of us when we have questions. we appreciate the wonderful work that you do. this may be -- we will have plenty of opportunity to continue to work with you. may be your last appearance before this committee. that will be a decision i would suspect of a new president of the united states at some point. but we hope it's not your last appearance here, quite frankly, just speaking for myself personally. i again want to thank you for the exceptional leadership that you have shown at the nih for a lifetime. that would go to all of you, quite frankly, of putting the health and security of our people but all people as your principal goal in life. it's quite remarkable. you are all very, very
distinguished in your own fields. to see the manner in which you collaborate together and work across disciplinary lines and institutional lines is really very inspiring. so we again just appreciate the values that you show and the basic and decent humanity that each of you exhibit. it's no surprise to me that it's the nih that tends to bring this committee together where it puts aside partisan differences, ee ideological differences to try to advance and support the splendid work you are doing. i'm sure that will continue. we will have other things we will fight about. but this isn't going to be one of them. this is going to be one of the areas where we work together. frankly, where we protect the discretionary funding that you got last year due to the bipartisan efforts on this committee. we try to build on that. frankly, we're hopefully, dr. collins, we can go to the sunny question i asked and that is perhaps do better than even the president proposed, certainly as proposed a generous increase,
lifeline subsidy program and the plan to improve broadband internet access to bridge the divide between higher income and lower income americans. the fcc will take up the proposal at the end of march. we'll speak with the policy director at the benton foundation and daniel lions, visiting scholar for technology policy. we're joined by brandon, technology reporter. >> low-income consumers need access to broad band now. it is unclear to me that congress would be able to pass a support for -- that's directly aimed at low-income users. this congress has not been particularly supportive of folks who are in poverty. the conversations that have been on the hill have been hard to
decipher. >> these are the drivers keeping low-income people from adopting broadband service and this is the amount we're going to need. we don't know if we're going to need $9 million or 4 million. the fcc hasn't done that level of analysis. >> watch "the communicators" tonight at 8:00 eastern on c-span 2. i am a history buff. i do enjoy seeing the fabric of our country and how things -- just how they work and how they are made. >> i love american history tv. american artifacts, they are fantastic shows. >> i had no idea they did history. that's probably something i'd really enjoy. >> and with american history tv, it gives you that perspective. >> i'm a c-span fan. >> the brookings institution
hosted a discussion today on monetary policy and how the u.s. might respond to a recession. live coverage beginning at 2:00 p.m. eastern on c-span 2. later today, republican presidential candidates, john kasich and ted cruz and donald trump speak to aipac at their annual policy conference. the senate finance committee held a hearing on healthcare.gov. officials with the health and human services department and the government accountability office outlined recommendations on how to improve implementation of the affordable care act. this is an hour and five minutes.
the committee will come to order. it's been a little disruptive here this morning. we have a lot on our plate. today, we'll be speaking with the department of health and human services and from the government accountability office about their oversight work with respect to health care got gcar enrollment in the entity. i want to thank them both for their work and contributions that both have made to help this committee perform more accurate and timely oversight. now, it is no secret that i have never been a fan of the so-called affordable care act. the evidence overwhelmingly shows that i and the many others oppose this from the beginning
has been right all along. the facts speak for themselves. since obamacare was sent into law, hh s&l ig and gao have released at least six dozen reports detailing various operation and implementation issues demonstrating numerous areas where the law is falling short. these reports are specific and focused on key operational failures like systems issues. some of which we'll hear about today. let's keep in mind that gao and hhsoig are not bipartisan entities. they are independent watch dogs tasked with the responsibility of assessing what is and what is not working in various federal programs, including those created or amended by the affordable care act. there's no better record showing how this happened in the reports we received from these offices.
today we are going to specifically discuss operations issues related to health care got g care.gov and enrollment problems at the federal insurance marketplace, otherwise known as the federal exchange. let's start with healthcare.gov launch. with the deployment of healthcare.gov and it's supporting systems, customers -- really, consumers -- encountered widespread performance issues when trying to create accounts and enroll in health plans. after numerous inquiries and reports, we know what caused these performance issues. for example, there was inadequate capacity planning. the centers for medicare and medicaid services cut corners and did not plan for adequate capacity to maintain
healthcare.gov and its supporting systems. there were problems with the software that were entirely avoidable. they identified errors in the software coding for the website, but did not adequately correct them prior to the launch. we saw a lack of functionality. cms did not adequately prepare the necessary systems and functions of the website and its supporting systems prior to the initial launch. cms also failed to apply -- recognize best practices for system development which contributed to the problems. admit teddedly, since the initial launch, cms has taken steps to address these problems, including increasing capacity, requiring additional software quality reviews and awarding a new contract to complete development and improve the functionality of key systems. however, many of the problems have still not been entirely resolved and continue to cause frustration, especially for consumers trying to obtain
health insurance. now, i wish we could boil down all of obamacare problems to the function of the single website. indeed, if this was just an i.t. problem, all of our jobs would be a lot easier. however, the problems with obamacare and the federal insurance marketplace in particular go much deeper. and many of them remain undressed. now, we know, for example, that the enrollment controls for the federal marketplace have been inadequate. during undercover testing by gao, the federal marketplace approved insurance coverage with taxpayer funded subsidies for 11 out of 12 fictitious online applicants. in 2014, the gao applicants, which once again were fake, make up -- made up people. obtained roughly $30,000. in annual advanced premium tax
credits, plus, eligibility for lower insurance costs at the time of service. these fictitious enrollees maintained subsidized coverage throughout the year, even though the documents or no documents at all to reserve the inconsistencies. while the subsidies, including those branded the gao's fictitious applicants are paid to health care insurers, they neverless represent a benefit to consumers and a cost to the government. now, gao did find that cms relies on a contractor charged with document processing, to basically uncover the -- to uncover and report possible instances of fraud. yet gao also found the agency does not require that the contractor has any fraud detection capabilities. and according to gao, cms has
not performed a single comprehensive fraud assessment. recommended best practice of the obamacare enrollment and eligibility process. until such assessment is completed, cms is unlikely to know whether existing control activities are suitably designed and implemented to induce inherent fraud risk to an acceptable level. in other words, cms isn't even sure if cms' fraud prevention systems are resigned correctly or if they are effective. lastly, while it was not the focus of the reports that is covered by the testimony today, another event that we've been tracking closely and where the gao is issuing a report today is cms' oversight of the health care co-ops.
there was a failure of the co-op program. today's report describes the effort to deal with the financial or operation issues at the co-ops, including an escalation with serious problems that may require corrective problems to oversight. as of november 2015, 18 co-ops had enough problems to submit to a cms escalation plan, including nine that have discontinued operations. just last week we heard that yet another co-op, the one many maine, is on the verge of financial dissolvency despite the fact that it had been on a cms-mandated escalation plan. in other words, cms' efforts appeared to have failed just like virtually every other element of this program. the failure of cms to adequately
implement the co-op program is well documented here on the committee and elsewhere. the rhetoric surrounding this program has fallen short of reality. with nearly half of the co-ops now closed, the failed experiment has wasted taxpayer dollars and forced patients and families to scramble for new information. with so many co-ops now in financial jeopardy, i believe cms should work with and not against states to safeguard taxpayer dollars. so, as always, we have a lot to discuss. i look forward to hearing more from the officials we have testifying here today. so with that, i'll turn to senator wyden for his opening remarks. >> thank you, mr. chairman. mr. chairman and colleagues, it is old news that the initial rollout of healthcare.gov three years ago was botched. it is new news that the
inspector general of the health and human services department recently said -- and i want to quote here. this is a quote from the inspector general. "cms recovered the healthcare.gov website for high-consumer use within two months and adopted more effective organizational practices." that's what the inspector general said. that the department recovered the website for high-consumer use within two months. that quote comes from one of two reports looking back at 2013 and 2014, that the finance committee will be presented with today. and i think we ought to start by recognizing that the story here is well-documented. after the launch went badly, some of the best minds and technology and a new contractor were brought in. they scrambled to overhaul the system and the exchange was soon
up and running. and the center for medicare and medicaid services is now following up on each of the inspector general's recommendations, which the inspector general notes in its report. in the most recent enrollment period, nearly 10 million americans used healthcare.gov to sign up for a plan or re-enroll automatically. in my home state, which had its own problems, close to 150,000 persons have used the website to sign up for a plan as of january 31st. that's up by more than 30% compared to last year. the committee will also hear an update from the government accountability office on what has been called the secret shopper investigation. the general account -- the government accountability office first brought this study before the committee in july of last year. and i'm going to repeat what i said back then. on this side of the aisle, we don't take a back seat to anybody in fighting fraud and
protecting taxpayer dollars. one dollar ripped off is one dollar too many. but let's recognize that what was true last summer remains true today. this gao investigation has not uncovered one single shred of real-world fraud in the insurance marketplace. it was built on fictitious characters with specially created identities, not real consumers and not real fraudsters. it's true that the government accountability office found that there are sometimes differences between the information on somebody's insurance application and their tax forms and citizenship records. but when it comes to these incon sti sitencies, health and human services did not look the other way when they found the red flags. in the year of the gao investigation, the center of
medicare and medicaid services closed more than 100,000 insurance policies because documents didn't match or weren't provided. tax credits were adjusted for nearly 100,000 households. in 2015, health and human services closed more policies and adjusted more tax credits. if you come at this from the left, you might say that's too harsh. if you come at it from the right, you might take a different view. but there's no basis whatsoever for the argument that health and human services ignores problems in people's records or leaves the door open to fraud. it seems to me, rather than rehashing old news, we ought to be looking at the facts and talking in a bipartisan way about how to move forward together. because of the affordable care act, a number of americans with now health insurance is at or near the lowest point in half a century. for the 160 million people who get their insurance from their
employer, colleagues, premiums climbed 4% last year. let me repeat that. for 160 million people who get their insurance from their employer, premiums climbed only 4%. working-age americans in oregon and nationwide with pre-existing conditions, 80 million people or more can no longer be denied insurance. so instead of battling out what happened three years ago, we ought to be pulling on the same end of the rope and solving some problems. for example, democrats and republicans ought to be working together to look at ways in which we can provide even more competition and bring costs down for consumers and a lot of you in this room have worked with me on that issue for some time. second, they are going to be spectacular new cures in the future and real questions as to whether our health care system is going to be able to afford them. here, senator grassley has worked very closely with me to
put together a bipartisan case study which looked at one blockbuster drug involving hepatitis c. solving the cost of the blockbluster drugs is going to take a lot of hard work. it, again, can only be done on a bipartisan basis. and finally, i want to express my appreciation to colleagues on both sides of the aisle because i think we are on the cusp of being able to make real progress on a huge opportunity for older people and our country and that is protecting the medicare guarantee. this very sacred guarantee we have for seniors while updating the program to look at the great new challenge, which is chronic illness. i want to thank senator bennett who was out in front of this issue for some time. he's not here but senator isakson and senator warner were champions as well.
i want to express my appreciation to the chairman for the progress we are making. i have to comment on something we didn't know about until about an hour ago and that's this matter of the co-ops. what we have said is that we want to work in a bipartisan way to improve a variety of sections of the affordable care act. now, this new material on the co-ops which either me nor anyone on this side knew about, was available about an hour ago, i intend to look at it with an eye on what can be done on a bipartisan basis going forward. but my work, and i think the work of colleagues here, always ought to come back to this idea of making the health care policy more accessible and affordable and i'm not participating in any celebration of people suffering because the co-ops were tied up
in a congressionally induced economic straight jacket. thank you, mr. chairman. >> thank you, senator. i'm going to introduce today's witnesses. our first witness is miss erin bliss, valuation and inspections in the office of inspector general or oig at hss. miss bliss has served in many roles since her career began. i think your career began in 2000, if i got it correctly. she started as an analyst for office of evaluation and inspections and later went on to serve as a senior adviser where she provided management advice and expert analysis to the inspector general and other senior executives on priorities and internal policies and operations. afterwards, she worked from 2009 to 2014 as director of external affairs at oig and was responsible for overseeing and implementing the communications
strategies and relationship management with the administration. congress, media, the health care industry and providers and the public. miss bliss received her bachelor's degree from the university of notre dame before receiving her master's degree in public policy from the university of chicago. our second witness is mr. seto bagdoyan with forensics audits and investigative service mission team. during his gao career, mr. bagdoyan has served in a variety of positions including as legislative adviser in the office of congressional relations and as assistant director for homeland security and justice. mr. bagdoyan has also served on congressional details with the senate finance committee and the house committee on homeland security. we're glad to see you back here again. am i pronouncing that right,
bagdoyan? pretty close. okay. that's good. mr. bagdoyan has held several seats in the private sector, including most recently focusing on political risk and homeland security. he received his bachelor degree in international relations and economic from clairmont mcken na college and mba in strategy from pepperdine university. i want to thank you both for coming. we'll hear the witness testimony in order that they were introduced. so miss bliss, just please proceed with your five-minute statement. >> thank you. good morning, chairman hatch and other distinguished members of the committee. thank you for the opportunity to testify today about the office of inspector general's case study which examines the management of healthcare.gov. this is the website consumers use to apply for health
insurance through the federal marketplace. as is well-known, on october 1st, 2013, the healthcare.gov website failed almost immediately upon launch. yet within two months, cms had a substantially improved the site's performance. how did such a high-priority project start so poorly and how did cms turn the website around? our case study provides insights into these questions and lessons learned to help healthcare.gov and other federal projects work better. we believe our assessment of the intersection of technology, policy and management can benefit a broad range of programs. our report chronicles the breakdown and turn around of healthcare.gov over a five-year period. i'll summarize the highlights. from the outset, the healthcare.gov project faced a
high risk of failure. it was technically complex with a fixed deadline and many uncertainties. still, hhs and cms made many missteps in its implementation. most critical was the absence of clear leadership and overall project responsibility which had ripple effects. policy decisions were delayed affecting the technical decisions. policy and technical staff were in silos and not well-coordinated and contract management was disjointed. changes to the project were not well-documented and progress not adequately monitored. this culminated in cms not fully communicating or acting upon many warnings of problems before the launch. cms failed to fully grasp the poor status of the build. one reason is that no one had a full view into all of the problems and how they fit together. red flags raised to leadership did not always float a staff
working on the build and staff did not always alert leadership to problems on the front lines. cms was unduly optimistic. last-minute attempts to correct problems were rushed and insufficient. in the two months before the launch, cms added twice the staff to the project and cut many planned website functions. in just 72 hours ahead, cms asked its contract to double its computing capacity. even with these efforts, the healthcare.gov website experienced major problems within hours of its launch. the website received five times the number of expected users but the problems went beyond capacity. the website entry tool worked poorly and software coding defects caused malfunctions. cms and its contractors did not have tools to diagnose these problems. however, cms pivoted quickly to make corrections to the website.
they brought in additional staff and expertise from across government and the private sector. one key was was creating a badgeless culture where federal employees and contractors worked together as a team. cms designated clear leadership, integrated policy and technical staff and developed redundant systems to avoid future website problems. cms also took a more realistic approach to building website functions. it practiced what officials called ruthless prioritization, which focused on effectively developing the most critical functions, like re-enrollment and delaying other features. they measured progress and monitored problems to respond more quickly and effectively. these factors contributed to an improved website and important organizational changes. looking ahead, cms continues to face challenges and improving healthcare.gov and managing the federal marketplace.
this includes addressing more than 30 recommendations from oig's other federal marketplace reports. we will continue to monitor cms' actions and response to our recommendations and its overall management of this and other programs. thank you again for inviting oig to speak with the committee today and i'll be happy to answer your questions. >> thank you so much. mr. bagdoyan, we'll turn to you. >> good morning, chairman hatch, ranking member wyden and members of the committee. i'm happy to report on the 2016 results for aca health care coverage obtained during the 2014 open enrollment period. our results are based on extensive forensic analyses of relevant data from cms and other agencies such as ssa, irs and dhs involving originally the entire 2014 applicant and enrollee universe and are
independent of the undercover work we performed for that future. the federal data services hub is the primary vehicle for cms to initially check information provided by applicants against various federal data sources. in addition, the aca established a process to resolve inconsistencies. i.e., situations where information doesn't match application sources. coverage offered through the federal marketplace is a significant expenditure for federal government. current levels of coverage involve millions of enrollees of whom 85% received subsidies. cbo has subsidy costs at $880 billion for 2016 through 2020. while subsidies are paid to
insurers and not directly to enrollees, they present a financial benefit to them. as i've stressed before, a program of this scope and scale remains inherently at risk for errors, including improper claims and fraud. it's essential that effective enrollment controls are in place to help narrow the window of opportunity for such risk and safeguard the government's investment. against this backdrop, i'll now discuss our two principle analytical results. first, we found that cms does not track or analyze aggregate queries to the extent to which a query agency delivers information responsive to a request or whether an agency reports that information was not available and in this regard, for example, we found that ssa could not match 4.3 million queries related to names, dates
of birth or social security numbers and 8.2 million queries related to citizenship claims. irs couldn't match queries involving about 31 million people related to income and family size and within this, 1.3 million people had i.d. theft issues. and finally, they could not match 510,000 queries related to citizenship and immigration status. accordingly, cms foregoes opportunities for gaining valuable insight of integrity issues, including vulnerabilities to potential fraud as well as information useful for enhancing overall program management. second, we found that cms didn't have an effective process for resolving inconsistencies for applicants using the marketplace. for example, 431,000 applications with about $1.7
billion in associated subsidies still had about 679,000 inconsistencies unresolved as of april 2015. that's four months after the close of the 2014 coverage year. within these, cms didn't resolve social security inconsistencies with about 154 million in associated subsidies and 22,000 applications with about 68 million in associated subsidies. by leaving inconsistencies unresolved, cms risks granting eligibility to and making subsidy payments on behalf of individuals unqualified to enroll in health care plans. according to irs, accurate ssns are vital for income tax and
advanced premium tax credits through filing tax returns which is a key back-end control under aca. in closing, our work today collectively shows that cms has assumed a generally passive approach to managing fraud risks in aca, weakening the program's integrity. accordingly, we continue to underscore that cms needs to make aca program integrity a priority and implement effective controls to help reduce improper payment and fraud risks and preclude them from being embedded early in the program's life cycle. in this regard, we made eight recommendations in our february report which are intended to help mitigate the vulnerabilities and risks we identified. while the agency agreed with the recommends, it is incumbent on cms to implement them in a timely fashion and achieve and sustain measurable results. mr. chairman, this concludes my statement. i look forward to the committee's questions and i
appreciate the indulgence for an extra 30 seconds. >> happy to give that you extra time. and miss bliss, previous reports at the office of inspector gene criticized healthcare.gov and the marketplace, describing important problems with internal controls, such as inadequate procedures for checking the eligibility of enrollees. how does the case study differ from previous reports of the office of inspector general on the same topic? >> thank you for your question, chairman. the case study is one of a dozen reports that oig has issued on the federal marketplaces. most of those were more targeted audits or evaluations examining aspects of eligibility controls, payment accuracy, contracting and security of information. the case study took a different approach and cast a wide lens at cms's management of the project
in its entirety from multiple perspectives and over a long period of time in order to glean lessons learned about what went wrong and what went right in an effort to improve both this healthcare.gov project and other federal projects moving forward. >> thank you. mr. bagdoyan, your report pointed out the key role played by the "data services hub," which is the electronic clearinghouse for checking applicant information against federal databases. now, you said that cms needs to make better use of this important enrollment control process. would you explain that a little bit? >> i'd be happy to do that, mr. chairman. basically, the data hub is a key cog, if you will, in the overall control environment for aca. it's up front. it processes a lot of queries for information. a lot of those queries -- all of those queries, are, in fact, not
captured for future analysis. we believe that such capture and analysis would provide cms with a lot of insight into potential indicators of improper payments as well as fraud. so, a comprehensive control systemmmmmwould, theoretically, enable that sort of analysis for the long term, and we do actually have a recommendation to that effect to krmsicms. >> thank you. we've been long told by cms, don't worry, even if there are issues with the wording subsidies, everything eventually gets fixed when people file their income taxes, unquote. but gao found practices that undermine tax compliance. am i right about that? >> yes. a number of the inconsistencies we identified out of the
431,000, i believe we had about 35,000 that involved tax, or ssn inconsistencies. and according to irs, whom we discussed this at length, they told us that this was not only important for tax compliance purposes but also for the tax reconciliation process to reconcile the advanced premium tax credits at the end -- this is the third main back end control, if you will, in the overall setup. so, without that information that's accurate and reliable, irs pointed out that their job is made much more difficult to not only do the tax return processing, but also reconcile the subsidies. so, it's a long-term problem if it's not addressed. >> all right. ms. bliss, what are the most important lessons learned from healthcare.gov for the administration? and do you think that the lessons learned from your case
study apply to other large programs and projects, whether being planned by the department of health and human services or other government agencies? >> thank you. we certainly do. the intersection between policy, technology and management is not only essential for healthcare.gov, but we believe these lessons will apply to other federal projects and federal programs. we gleaned ten lessons learned, and i will highlight what i believe to be the three most significant. first is establishing clear leadership. we found that the lack of clear leadership and overall responsibility and clear lines of delegation had ripple effects, caused a number of cascading problems across the project and made problem resolution more difficult. we also found the disconnect between those working on the policy and making decisions and those working on the technical aspects of the project created
problems on both sides and delays in policy decision-making compressed an already tight time frame for achieving the technical build successfully. so, better integration across lines of business, policy and technical, as well as across government and contractors through this badgeless culture are some of the keys we saw to correction and success. and finally, taking a posture of continuous learning, which means being flexible and adoptable, especially with a start-up project like healthcare.gov was. we felt that cms got stuck on an unwinnable path, and it was too late before they realized and tried to make changes. so, keeping that continuous learning posture, being innovative and flexible and constantly monitoring for problems to adjust plans where needed. thank you. >> well, thank you. senator stabenow, we'll turn to
you. >> thank you very much, mr. chairman, and welcome and thank you to both of you. ms. bliss, i'm wondering, just yes or no question. based on your case study, do you think that healthcare.gov website should be taken down and completely new website be built? >> no. >> okay. thank you. like many of my colleagues, we're very frustrated about what happened in the past. clearly, you've laid out the problems with the launch, and i think everyone agrees that there were serious problems with the launch of healthcare.gov, and it created a lot of difficulties. and certainly, for people in michigan to get coverage in 2013. but that's six years ago, and we're now in year three of the affordable care act marketplace operations. and so, when we look at the reports, you know, the report is really looking backwards, and we can agree, problems.
the question is moving forward and how do we address the fact that over 20 million people have received health care coverage because of the affordable care act, and literally saving people's lives. that's not just a rhetorical statement. i've talked to people who were able to get surgery or be able to get care for their children that they've never been able to receive before and save lives. and i think that is a good part of things when we talk about the numbers, you know, real-life experiences of people. the uninsurance rate is the lowest it's ever been. and medicaid expansion has resulted in literally millions of our most vulnerable families receiving the care that they deserve. so, given the fact that the aca's the law of the land, and it's our responsibility to make it better, i first want to say that i hope that all of us will work on how do we make it better. and that's why we appreciate your recommendations as we look
forward, not just on this particular website and process, but in others as well. but the question is, how do we make it better. so, it's, we want to make sure that we have quality access to health care for every american, whether it's medicare, medicaid, the children's health program and so on and so on. so, with that in mind, mr. bagdoyan, let me ask about any other recommendations from a gao standpoint that you haven't already spoken of today on how we can make things better, because frankly, i want the over 20 million people that have health insurance today that didn't have it before and have the peace of mind of going to bed at night to know they're going to be able to take their children to a doctor if they get sick -- i want to keep that. and so -- and i'm hopeful we can even get, you know, as close to zero as possible in terms of the number of people in our country that don't have access -- that
have access to health care that, you know, that we can get to zero the number of people who don't. so, i'm interested in your recommendations on how we go forward to work together to make this system work better. >> sure. thank you for your question, senator stabenow. as you mentioned, we operate under the premise that this is the law on the books, and my charge is to help make it work as intended. with that in mind, our report makes eight specific recommendations. we try not to be too prescriptive to allow cms some latitude to explore various options. however, the key recommendation, i believe, the big-picture recommendation, is for cms to conduct a comprehensive risk assessment of the entire program, sort of top to bottom, and identify the control vulnerabilities and the risks for improper payments and fraud.
and in that regard, gao issued in july of 2015 its framework for managing fraud risk in federal programs. so, that's a comprehensive leading practice compilation from the private and public sectors that would provide the agency with quite a solid roadmap to perform that risk assessment. so, everything should flow from that assessment in terms of the types of actions, policy changes, control improvements and so forth. >> and are you working with cms? what is their reaction on this? are they objecting to that? >> no. i think i should give cms credit that they accepted all eight recommendations, including this one. but as they say, the proof is in the pudding. they need to execute, do so successfully, and then achieve results and sustain them over the long term. this is not a one-and-done proposition by any means. >> sure. but so, just to be clear, you've made the