ago, fee for service with no link to quality. category 2, fee for service payment, pay for performance that has some link to quality or value. so think of programs like hospital value-based purchasing or the hospital acquired condition program and reduction program or, under the physician side, the modifier. category number three is alternative payment models and this is the work of the innovation center. they are largely built on the fee-for-service architecture as described. something is like the accountable care organizations bundled payments, advanced primary care medical homes. category number four is the future, where that payment is no longer tied to the delivery of a particular service, but it's tied to taking care of entire populations.

these are the goals that the secretary announced. really focus on the dark circle on the page. the dark circle is the percentage of medicare fee for service payments in the alternative payment models. in 2011, they were zero. no medicare payments in the model. in 2014, at the end of 2014, about 20% of the $362 billion of the medicare fee-for-service payments, excluding medicare advantage. but the numbers are similar. 20% were alternative payment models. the goal is by the end of 2016 30% of the fee-for-service payments will be in the new alternative payment models that work and 50% by the end of 2018. so this is the first time in the history of the medicare program that we have set broad national goals, and what is critical to understand is it's not just a medicare project.

this past wednesday at the white house, you may have seen president obama picked up something called off something called for health care learning action network where we have convened a commercial payers medicare organizations and purchasers to join us in matching or exceeding these national goals and for the last five years, the division center has been using a number of strategies to bring the private sector a long in reaching these alternative payment model targets. so in a number of models we actually convene commercial payers and ask them to do models with us. in some of the models we give providers the incentives and we say we are going to enter the contract with you, but by the end of the second year we want you to enter the alternative payment model with other payers.

and then thirdly partnered with states through a number to convene the commercial peers and help us achieve these targets. so part number two, what do we see in terms of the results? taking a risk knowing who else is on the panel so we can have a debate about this, but one fact is true we see an unprecedented slowdown in per the per capita medicare expenditure growth for part a and b. we think that at least part of the power here is the changes in payments, changes in the way that we are paying providers. similarly, we have seen a significant reduction in the medicare costs and hospital readmissions, and this means from 2010 to 2013, about 150,000 fewer patients were readmitted to hospitals, and readmissions are a key measure of the health care quality. by show of hands, how many of

you have at least heard of the term accountable care organization? almost everyone in the room. i will give you 30 seconds of dramatic oversimplification of what it is. aco is a group of providers that get together and say we are going to be accountable for these 10,000 or 30,000 patients and this can be in the commercial world or in the medicare world. now what that means is we've got these beneficiaries and we look at how much they cost over some historic period of time and that is the baseline. then we use a formula to project what we think they are going to cost over the performance year. that is the benchmark. and the aco contract is a deal between the group of providers and medicare. and we say if you beat the benchmark, we will share in the savings.

if you exceed that, we will share in the losses. by the way, we will measure you on the 33 measures of quality. and we are going to adjust those payments based on your performance on those measures of quality. so we have two years of public results, and the pioneers beat the national benchmarks on measures for which they are comparable national benchmarks and they beat benchmarks on four out of four patients experience measures for which we have comparable benchmarks, and then they improved by the composite in the second year. for two years in a row, they generated savings were up $284 million into the savings increased from $2.7 million in the first year to $4.2 million in the second year. so they are organizations that are advanced and they have an experience in bearing the risk

and delivering care in this new world of delivery system reform. another model the partnership for patient is pretty patchwork of programs including some of our pay-for-performance to improve care in the hospital. partnership is a model where we invited about 75% of hospital ceo's in the country to join us in setting up aggressive targets to reduce the patient harm in hospitals. three numbers for you from 2010 to 2013. 50,000 lives saved, 1.3 million patient harm events avoided, and $12 billion in the savings. a couple of seconds. the section 2031 is one of the most inspired sections of the aca. i love it.

i would think of it this way. we are scientists, so we are testing models. if we have a model who works, we have scientists to evaluate these models. if they improve quality and the and the cost remains neutral, or option number two, if the quality is neutral and cost is reduced, or option number three the one we all hope for if quality goes up and cost comes down, the secretary of the secretary of health and human services has the authority to expand these models nationally in duration and scope. this is a quick overview of the portfolio testing about 25 different models. we couldn't talk about all of them today, but it's in your package. this is a slide that shows innovation is happening pretty much everywhere in the country. this is a map that shows where our aco's are.

they are currently aligned or signed and we have more than 400 operating now. last slide, here's what i think you will see over the next couple of years. we are increasingly focused on integrating with the rest of cms, a really important point. it is a part of cms. we couldn't function without the cms. everything we do is to improve the program that the agency runs. we are focused on evaluating the results and launching them in the portfolio. i think you will see a steady drumbeat of results and expanding models that work. one very last thought, trisha gave you three reasons why it's important. i want to add one more to that list, so here is reason number four. all of us, should we live long enough will become medicare beneficiaries. we can work on other areas of domestic policy and it would never touch your personal life

but if you live to the age of 65, but god forbid, you will become a medicare beneficiary. and that's right the delivery system reform actually matters because, in the brief time that i've been in the government can i have been admitted to a hospital myself and i've taken my children to see the pediatrician. we will all be patients. so this matters not just a matter of public policy and to your bosses but to all of us as individuals. again, thank you for inviting me. i look forward to your questions. >> thank you very much. the final panelist today is a sheila burke a faculty member at the school affiliated with the public policy law firm. she spent a number of years on the hill as many of you know most prominently as senator bob dole's chief of staff if she was a member of medpac and serves on a number of the nonprofit boards. sheila is our designated visionary today charged with

identifying some of the major challenges facing medicare as it enters its second half-century and i'm looking forward to hearing from you. ms. burke: thank you very much. i have to admit i've never been called a visionary but maybe it is my trifocals reflecting my age. it's a pleasure to be here to talk about the medicare program. i am essentially going to start where juliet left off and then try to reflect looking forward on what some of my colleagues have commented on in terms of the challenges facing medicare but i want to begin by underscoring a point that was made on how we pay, who we pay and what we pay for makes an enormous difference. as the have seen since the passage of the program in 1965

and as medicare goes, so largely does health care delivery systems. we saw it and how we transition the payment and how that occurred. the private sector has an enormous role as well, but the collaboration that we put in place with respect to the private sector will in fact fact drive the delivery system going forward. so again, let me start with where juliet began. let me talk about these three groupings of issues on the spending finance beneficiaries and providers and again reflect a little bit on what we might expect both short-term and long-term to try to look at the program going forward. while much has been made about the slowdown in the medicare spending, it will continue to be an issue of tremendous concern to your colleagues and to your members. in part, obviously, as you can see from the pie chart, it consumes a big piece of the federal outlays, and that is growing.

it's an issue because a portion is financed by payroll taxes and the workforce is not expected to keep up with the number and the growth of the beneficiaries. by 2030, we are looking at approximately 2.3 million workers per retiree, so that as an underpinning of the financing and it becomes an issue in terms of long-term stability. an issue as well is because the increasing percentage of funding that is required out of general revenue, the other portion of the medicare financing package as was pointed out, leaving far fewer resources available for the other federal priorities. again if you look over time it at the changes in the social security, medicare, and medicaid, they become an increasingly huge part of what it is we spend on the federal side. medicare costs have slowed down. they are expected to go from 4% in 2013.

but at the same time, the gdp is only projected to rise 3 per 5% -- 3.5%. so again, all of this causes us to continue to concern ourselves with what medicare is spending. the demographics are working against us. the baby boomers are arriving, and while many of us are relatively healthy notwithstanding my trifocals and arguably less expensive for the near term that changes. the good news we are living longer. the bad news is we are more expensive as we get older unless we live until 95, and then you become less expensive when you die. in 2011, the average per capita medical spending tripled between the ages of 66 and 96. it is not entirely achievable to

end of life care. we hear a great deal of what they can to lose, but that is in fact not the only factor. many cases, there are individuals are chronically ill and the management of these patients is enormously important. and there are the sheer numbers. these are people who are going to be eligible. the first they beat boomers began to arrive in 2011, when approximately 40 million americans were a over the age of 65. by 2030, that number will have grown by 30 million, and by 2050, that number will have grown by 40 million. so as you can see the percentage of the old old, as in the orange and yellow boxes in this chart grows very quickly. and again if you think back to the chart in chompie's amount of per capita spending that increases as people age, you see we are looking at a growing number of individuals who, in fact, will be the most expensive portion of the medicare program at the same time we have fewer young people coming in and fewer

people pay payroll taxes to essentially support the program. and, of course, among those who are the most costly, and juliette touched on this issue are those who are dual eligibles which we'll talk about for a moment. but rising health care costs in addition to an issue for us is also an issue for the beneficiary. as juliette pointed out, as the population there not all living in palm beach. they are relatively low-income population in terms of looking and medicare. health status and chronic conditions are also significant drivers of health care costs and out-of-pocket spending, which becomes an issue and rises with a number of conditions that, in fact, that you have. you recall some of the gaps in coverage that juliette mentioned. most significant is long-term care, which is an issue we have successfully avoided dealing

with for a number of years. but those are major contributors in terms of that, as will simply -- well as simply the program itself. as note i would say women are disproportionately represented in this group with the highest out of pocket cost and they tend to live longer. women tend to be caregivers for their spouses for many years or for their parents. they tend to live longer, have more conditions, and tend to confront these out-of-pocket costs. and often in fact you see they become substantial at ages 75 to 84, and 85 and beyond the as i noted and as julia pointed out the our unique population within the medicare population but also as we begin to think about the beneficiary challenges that we are confronting. of the duals, who are individuals were both low income and eligible for both medicare

and medicaid, are disproportionately counted among the high spenders. they are you a unique challenge in terms of managing his population. they are poorer. they generally have more medical needs and other beneficiaries. they are more likely to be frail with multiple chronic conditions and have functional and cognitive impairments. there are approximately 9 million of those individuals and of concern to the federal government as you look at the spending for the medicare program and planning going forward their are a huge issue for the states are also financing and they are as this reflects also a very high-cost population for the state. as you look at inefficient issues and we look at the medicare program going forward looking at this unique population one of the provisions in the aca essentially begins to try and get the state medicaid programs and the federal medicare program to begin to coordinate with one another, which has not been the case in

the past. so people often fell through the cracks. their services were coordinated. their system payments were not coordinated, and many require things that fall outside of the traditional health care package. they require transportation services and often nutrition services and a variety of things that as we managed his population and look at the beneficiary challenges going forward, this will be among the most unique populations that the two programs have to contend with. finally, as part of the discussion with respect to providers, given the aging of the population, the increase in the number of beneficiaries, increasing attention is now being paid to workforce, which is something we have talked about in the past, but have not made great deal of progress on. overall, access to physicians and other health care professions is adequate, medpac tells us. however, there are clear differences in the access to specialty care versus primary care, with primary care being much more difficult to

essentially identify and align with in terms of beneficiary. this is in part a function and a result of the bias in medicare payment historically towards specialty services and the financial models, the history of silos that we pay people to do things has essentially discouraged the development of primary care and the availability of primary care providers. there's no question that our system of educating physicians and nurses is among the best in the world. but, unfortunately, they're not fully aligned yet in the education system in the changes in the delivery system that rahul has mentioned. it is evidence based care, multidisciplinary teamwork, care coordination across essentially sites of care so that we begin to think about people in the context of the full continuum of care, not simply in silos, hospital-based and hospital-based -- or the nursing

home patients or the home care patients that we begin to think about and pay for as has been suggested looking across the systems and the manpower workforce population has begin to think in those terms as well. medicare is the single largest payer for medical education. in 2009, we spent somewhere, approximately $10 billion a year on medical education. we paid far less with respect to nursing education, but these are levers that we begin to look at in terms of how we incentivize the choice of specialty, the movement into primary care and all these payment models, aco's and others, that begin to think about teen face care which is something our medical training programs and nursing thing and other providers need to begin to think about going forward and begin to think about it in school, not simply when they go into practice, so that we begin to get exposed to when i was in the school we practiced and were trained in largely a silo-based system rather than in a

disciplinary way. that's one issue we will be looking at. it's an important part of how we think about providers going forward. then quickly going forward, and the issues that have been raised, first there are the internal kinds of changes. we spent a fair amount of time this afternoon talking about payment reform, aimed at reducing cost and incentivizing changes in practice of specialty mix. the house passed sgr bills still pending in the senate. again is a movement, clear movement in that direction and that is towards payment reform movement away from fee-for-service an a link to quality. in the context of delivery system reforms, again the activities that were outlined by rahul in terms towards pushed towards organ systems of care, the focus on quality, care team-based care are all steps in this direction, and again is unique population of high-cost

high risk, and the duals will be at particular focus of attention for folks going for the eligibility and these are all again in criminal kinds of changes based on the program and benefit restructuring. again, the confusing structure of the medicare program that juliette outlined, suggestions about combining a and easily look much more like traditional health insurance comment also hopes to begin to organize in excess of the cost sharing and potentially provide some limits on out-of-pocket for catastrophic costs incurred by people. the reform and medigap, you begin to see the indie sgr bill. again, it's to get people skin in the game to remove the first dollar coverage, even for those under medicare so they become more sensitive about their providers they choose. the eligibility issues one that continues to come up and will no doubt come up again. 65 isn't what it was in 1965. people are living longer. they are staying in the workforce longer, largely healthy. so the question is, is that the right age? it was a big issue for years because people who fell through

the cracks, would they have private insurance available to them that was affordable? that now has been less of an issue the ability to purchase coverage through a network or through essentially an exchange rather than in the individual market. but again this question of who ought to be eligible and that what point will no doubt come up. then there's of course a final note which is this attempt to rethink the entirety of the medicare program and move away from a guaranteed benefit to a essentially a guaranteed contribution, and that is whether we ought to get out of the business essentially of the program as we know it today and begin to essentially allow people to take the money we give them on a per capita basis and purchase coverage, and it's really a step beyond medicare advantage as we know today but mr. ryan and others have talked about premium support so all of these things are things that he think of going to be both short-term priorities force as well as long-term. >> terrific. thank you, sheila.

let me remind you, you now have a chance to enter into this conversation. there are microphones at the four corners of the room. there are green cards that you can write a question on. if you do go to the microphone i would ask you to keep the question breathe and to identify yourself so that we can get you as many questions as we can do and i should remind you, this is a primer. there is no question that is too simple to ask. because that's what we're here for. >> yes, go right ahead. >> amy from the senate. i'm just wanting to know what you think about the government part d non-interface clause? on hearing a lot about that in what do you think the government could save costs if they're able to interview with those negotiations? thank you.

>> you might, whoever wants to take a crack at it, explain what is the we are talking about. juliette: the part d nonimmigrant clause basically references the fact that is part of medicare modernization act in 2003 which created the part d drug benefit their supervision that prohibits the government from interfering or doing any negotiating with pharmaceutical companies over prescription drug prices. there has been quite a fair amount of back and forth about this provision, and the question about whether the government could actually get a better deal for medicare beneficiaries who are enrolled in part d plans than the plans themselves. i think the congressional budget office has looked into this, i think medpac has looked into this, and i think the prevailing view is that the plans are doing a pretty decent job of negotiating rebates, and there is some question about whether the government could do a better job than the plans are doing

for most prescription drugs. one of i think sticking point about this issue though is drugs that are unique, that have no alternative, no generic substitute, no therapeutic equivalent, is there a way for the government to intervene or perhaps try to come up with some alternative way of arranging pricing for these drugs where there is no equivalent, where there is basically the pharmaceutical company able to kind of set whatever price it wants. and i think there are various discussions, perhaps not official discussions, but there have been ideas proposed about ways to get a better deal for beneficiaries on drugs where there is no ability for the companies themselves to negotiate with the pharmaceutical companies. so i think that's the issue where there could be a potential for medicare to play an important role. >> do you want to go ahead of there? >> sure.

question for rahul rajkumar. quality and cost reduction seems to be pretty easy achieved in the first couple of years, which soon takes a lot of -- beforehand. are the same solutions being thought about for the rest of the health care systems like the ac in the open program does or just for medicare? dr. rajkumar: that's a great point. a couple of things. we learn a lot from, in general, the approach that the center has taken to set the table for providers. and give them incentives to innovate in care delivery. and within any of our programs whether it's our primary care for bundled payments, providers are using lots of different strategies. what we see is that different providers are able to find different pockets of savings at

different parts of the system. i don't think that there is a single universal theme that we see in terms of how -- where there are savings to be had. i think, i interpret your question as a question about multiplayer online that, and i think that's absolutely critical success factor for payment and delivery system reform and it's a huge area of focus. so all or nearly all cmmi models attempt to engage other payers because if you think about it from a business standpoint, if you're a provider, you cannot succeed with one foot in fee-for-service and one foot in fee-for-service and one foot in acl or an alternative payment model but because of other operational strategy is different. if you try to keep patients out of the hospital for one population and then on the other side you are trying to maximize your hospital utilization, you can't manage two different

goals. so as i said, we tried a number of different strategies to engage other payers, and so in some of our models, we actually went around the country in seven different markets and actively convened about 30 payers to do the model with us. so cpcp actually -- we engaged these certain payers. and other models we have relied on the participants to go out and get the of the risk-based contracts themselves. i think the other huge effort you are seeing that was just announced this past week is we are not convening national payers, providers, and patient groups in a national health care payer learning action network, where our hope is that we will learn from one another about what the different factors for success are in alternative

payment models, and that the uptake of these models will spread and other payers will either match or exceed the pretty ambitious goal that we've set for the medicare program. >> i have one other question -- >> i just want to add one cautionary note, and that is the transparency of information. one of the things we hear about even within a single system is the inability to essentially easily access information across that system. and one of the challenges i think is, and this is true about multiple payers, but even in the context of a single system whether it's a kaiser system or any other integrated system, the inability to convene in one place all the information, the outpatient, inpatient services and track and share that information, the learning that

occurs by the ability sort of report on what is occurring across the system, and i think that's one of the things people struggle with is that ability because the systems don't necessarily match up. >> my other question is regarding medicare eligibility. because i encounter a lot of adults who have now brought their elderly parents into the country who are now new citizens and new residents, but will never have the 40 quarters that they need. so what is the thought process of the elderly adults who are now living in the country but don't have the eligibility requirements for medicare? ms. burke: to be perfectly frank it's not been an area of attention. you correctly note that the 40 quarter issue is one that is fundamental to the eligibility program and the focus has surely been on those who would otherwise qualify, and the question about the time at which they it into the system.

but not frankly a lot of attention to people who essentially don't qualify. you could imagine the unique set of circumstances, and trish will remind if i'm incorrect, every a unique set of circumstances early on with religious groups for example, who didn't and couldn't have 40 quarters. there was a commendation for state-based employees, so it's an issue that's not just unique for people who are coming into the country. people have chosen to for example, work-at-home. women have chosen to work at home and didn't have essentially 40 quarters of traditional work behind them and contributed into the system. so it's an issue that is broader than just that narrow population but it's not one that's been given a great deal of attention, to the best of my knowledge. [indiscernible] ms. burke: i don't know that it has come up to be perfectly frank, at least not in the recent discussions but it is a good point. it would apply not only in the context of new citizens, but to people who don't traditionally transition into the system. >> i have a question about incarceration -- >> do you want to identify yourself?

>> i'm from the senate side. so we have seen -- hi, i am emma. we've seen issues of mandatory minimums and such like that and we're keeping people in prisons longer and better care is becoming more challenging, especially as you develop chronic illnesses. so i was wondering, how does medicare sort of navigate what happened to that specific population so that people who do qualify while they're in incarceration, that that cost is redistributed to states or other health care providers? i know it's competition with state and federal, so any insight would be great. ms. burke: i can be easily corrected by anyone here. as a general matter is considered outside the medicare program as it is outside of the medicaid program in terms of the present system and the health care funding that essentially present context of the federal and state prison systems. to the best of my knowledge,

bob may recall, i don't think we crossed over in terms of medicare coverage. i don't think they carry their benefits to prison. >> i don't believe so. and one other, those who have paid into medicare or living abroad don't get the medicare coverage either. and that becomes an issue for some as well. the coverage is not portable except for emergency situation. ms. burke: good point. >> next question. >> my question to you is with regard to these problems we're having with the sgr coming up this year, do you feel the problem is more so rooted in the sgr formula that is inherent to the program, or is it more so to congress' inability to allow the cuts to go to plays and now they have compounded to 21% or 22% as we are currently facing?

>> yes. [laughter] ms. burke: i mean, one, i mean bob will comment on this, the ultimate structure, i think and we are confronting at the time in the part b program tremendous escalation of the cost of the program, and this was thought to be what you try to bring that under control. it was quickly realized was not to be a system that worked, and i think there's been, the holocaust related issues. you've heard a lot of discussion about, bargain basement price of the moment at $140 billion. so those issues have driven it but it's a combination of both. one it wasn't the right answer to the problem and secondly there was a great deal of reluctance to allow 15%, 20% reduction in physician payments. bob, you may have -- >> i agree with it. what i would emphasize just a couple of things. one is it was some fanciful thinking that would be a collective incentive that the medical profession somehow would come together and figure out how to collectively they

would live within this sort of target amount. but if you think about it for more than two seconds, you realize that the incentive on each individual's physician is to do more services in their fees are being cut rather than to participate in the collective. and that at the time we're being big on the notion of evidence clinical practice guidelines and that everybody could follow them and that would keep the volume down. there is a role for clinical practice guidelines but it got overemphasized at the time. i do want to get one fact out, which is that in the last decade, physician services were rising very rapidly. imaging services sort of doubled in a five-year period. that's all flat now. in addition to sort of overall health care spending being pretty flat, and medicare

spending being pretty flat, even physician services now, and so the sgr -- it became a political problem and a budget problem. it's never been a mechanism for actual restraining spending by physicians, so congress is looking at ways to try to get the incentive down to the individual physician level. i personally have some difficulties believing that what's happening is actually going to be for the good. in my view, we don't have the ability to measure at the individual physician level their quality or their resource conservation, how could they are efficiency. i think we can do that at a large group level. so congress is about to pass legislation that i don't think it's going to be achieve what it's nice goals are, this ability to measure at the individual physician level. >> great, thank you.

>> i should just point out we have five or six minutes left before the witching hour of 1:30, and i would ask you to pull out those evaluation forms and fill them out as you go through these last few questions. and it looks like we have someone at a microphone. >> hello, good afternoon. i have a question concerning the tuition assistance given to primary care physicians that practice care in urban areas and rural areas. there's been a little bit of doubt concerning the sustainability -- >> i'm sorry. stay a little closer to the microphone. >> i'm a little too tall. there's been a little doubt about the ability of funding these education grants. what do you all think about that? look into your crystal ball, but

what do you see about the sustainability of these tuition grant? ms. burke: there is a desire to incentivize the decisions that increase the number of primary care providers. this is to both with respect to positions as well as with respect to nurse practitioners. there was money in the aca for innocent program to create an opportunity for increase in the number of nurse practitioners as well. the question is always going to be, are the incentives resulting in what you hope to achieve? the national health service corps has a long history, the concern is people tend to go into those areas and they tend to leave. is that the right answer? although it has recently gotten additional funds, and i think there's additional money in the last piece of legislation. it's clearly something we've done. medicare has a strange sort of history of not wanting to interfere in those issues through the gme program,

although the reality is the way we pay has a direct influence on choices that are made in terms of specialties. but i would put odds on continued effort to increase the number of primary care providers. certainly, you have people particularly in the senate, and i'm sure it's true in the house as well, i know the senate far better, and by the commitment to maintain rural health care into the resources that are necessary in rural health communities and to a real question about what does that mean, does it mean having a hospital? i spent a lot of time in kansas, as you might imagine, and at 1.50% of the hospitals in kansas had fewer than 50 beds. went hospital shut down, the docs left, the nursing home left. lots of questions about what do we need to support rural america, what is the right answer to that problem.

i think there are enough people to deeply about that debt to be continued against i forget what the right solution is in terms of mix of services and the availability of care. >> i want to follow up. this is my chance to make my one quibble with the cms framework for categorizing payments to providers on this issue of how do we get more primary care, which i think we've all said and sheila in particular is the need. category one says there's no link to value. my view would be there's a fee schedule. we have a fee schedule that is tilted far too much towards procedures and tests and research that we've actually done as the urban institute, pretty well documents that medicare compensation to specialists exceeds that by

about 2 1/2 to 3 to 1, for every hour worked, at least for some specialties like radiology and cardiology. that's not sort of innumerable. we are making choices to have a fee schedule that is tilted in that direction. we could have a fee schedule and some of us have suggested that that recognizes many more primary care activities and, in fact, cms if moving in that direction by creating new code for complex chronic care management, transition care. we could also change the relative values so that the time spent with a physician was given much more payment than just interpreting a test. to me, if we did that, we would have a different mix of services. we would have different signals to what specialty to go into and we would be improving value. and i think in some ways we would be improving value more than just by adding a couple of quality measures, which gets you to category two. so the point i would make is that while i absolutely agree

with all the work that cmmi is doing to come up with good models for payments, how we actually what i call administered the legacy payment models are real important to producing more or less value. and even in some of these legacy payment models that i put up in some of the slides, we have a -- we havcee efficiency incentives. when a home health agency is paid for a 60 day episode for care, rather than each visit they have an ability to use telemedicine, to use different personnel to do a number of things that presumably can improve efficiency. so this division division between category one and the rest strikes me as a little arbitrary, and we don't -- in the policy world we don't pay enough attention to that category one. there are people in cms working hard to improve that, and the providers who the stakeholders in the systems are very involved

with that, but it somehow hasn't risen to sort of the same level of policy attention. it's a quibble or. -- it's a quibble. >> well, we have time for one more question. james. with -- my question is bouncing cause with innovation as we're going forward especially with durable medical equipment. items such as stair climbing wheelchairs might allow patients to stay in the house longer or a glucose monitor paid for in europe but not here. might have up front cost are longer but have long-term cities. how do we balance that? >> reasonable question. juliette: it is a reasonable question and one of the issues anyone else can chime in, from time to time over the years there's been several proposals that is come forward

and cbo is very skeptical organization and they look at these ideas of expanding coverage and they are very doubtful about cost offsets. savings. one of the opportunities that is out there with more people in capitated rate, there's nothing to stop medicare advantage from testing. whether some of the innovations you are talking about would provide the care people need in the most appropriate setting. that might be a real opportunity in a capitated framework that could be transitioned to traditional medicare and pride evidence needed by the congressional budget office. >> that was a good answer. that was a good way to end the program. this has been a terrific session, and i want to thank our panelists. i would ask you to help me in thanking our panelists.

we did not answer every question that everybody had come up and that is why we gave you the materials and the contacts where you can seek out more information. next wednesday, we will do a prim or on costs, if you can make it. we would love to have you. otherwise, thanks to our colleagues at the camera -- kaiser family foundation, and thank you for coming. we will continue our mutual education next week. [captions copyright national cable satellite corp. 2015] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org] >> senator harry reid today announced he will not run for reelection in 2016. he served as the senate

democratic leader for the last 10 years. senator reid made the announcement in a video posted online. senator reid: these bruises i have on my face, are an inconvenience, but they are nothing compared to some of the bruises i got when i was fighting in the ring. when i was a boy, i dreamed of being an athlete. i listened to those games on the radio, baseball games, and i envisioned me as a man out in center field in yankee stadium or fenway park in boston, but the joy i've gotten with the work that i've done to the people of the state of nevada have been just as the filling as if i had played center field at yankee stadium. the job of minority leader, and the united states senate and is just a support as being majority leader. it gives you so much opportunity to good things for this country and that's what i am focused on.

but this accident has caused us for the first time to have a little downtime. i have had time to ponder and to think. we've got to be more concerned about the country, the senate, the state of nevada, than us. and as a result of that, i am not going to run for reelection. my friend senator mcconnell, don't be too elated, i am going to be here for 22 months, and you know i'm going to be doing? the same thing i've done since i first came to the senate. we have to make sure that the democrats take control of the senate again. and i feel it is inappropriate for me to soak up all those resources on me and i can be devoting those resources to the caucus, and that's what i intend to do. the decision that i've made has absolute nothing to do with my injury. it has nothing to do with my being minority leader, and it certainly has nothing to do with

my ability to be reelected because the path to reelection is much easier than it probably has been for anytime i have run for reelection. >> i get a little upset sometimes when i hear politicians say that they're going to go and spend time with her family after they decide that they are not going to be in politics anymore. he's a wonderful husband and a wonderful father. so that's been more important than the other things that he's done with his life. senator reid: someone with my background, my upbringing, to have the experience i've had is really a miracle, i don't want -- and i want people in the state of nevada to know that i

am so grateful, and i have done my best. i haven't been perfect but it really tried my hardest to represent the people of the state of nevada. >> it looks like chuck schumer is likely the next senate democratic leader. senator reid has endorsed senator schumer for the post, as has take durban. senator durbin said he will seek to remain the number two and

supports senator schumer. other news, tammy duckworth is reportedly planning to chan -- challenge mark kirk in illinois next you. congresswoman duckworth will make an announcement on monday about her 2016 senate campaign. here are some of our featured programs for this weekend. on c-span2 saturday at 10:00 p.m. eastern government housing policies caused the 2008 financial crisis and that it could happen again. sunday afternoon at 5:00, a development plan to counter global issues like poverty political corruption, and environmental decay. saturday morning at 10:30 on c-span3, a discussion on last major speeches of abraham lincoln and martin luther king jr..

sunday afternoon at 4:00, the 1965 meet the press interview with martin luther king jr. find a complete schedule at www.c-span.org and let us know about the programs you are watching. call us, e-mail us, or send us a tweet. join the c-span conversation. like us on facebook. follow us on twitter. >> this sunday, a new book, "dead wake," the last crossing of the visiting a. >> it gets pitted when the question arises, what alternately happened to the lusitania? why was the lusitania allowed to enter the irish sea without escort without the kind of

detailed warning that could have been provided to the captain but was not? this has led to some interesting speculation about, was the ship is essentially set up for attack by churchill or someone in the admiralty? it is interesting. i found no smoking memo, and i believe i would have found a smoking memo if it existed, but there was nothing from churchill to jackie fisher or somebody else in the admiralty saying let's let the lusitania go into the rcf because he we want it to get some. nothing like this. >> sunday night at 8:00 eastern and pacific on c-span's "q&a." >> margaret hamburg spoke at the national press club today page is announced at the end of the month she is step down from

the fda after six years as commissioner. >> good afternoon, and welcome. my name is john hughes, an editor for bloomberg first word, heartbreaking news desk in washington, and i am the president of the national press club. the club is the world's leading professional organization for journalists. we are committed to our profession's future through programs like this, and we were for a free press worldwide. for more information about the club, visit our website, press.org. to donate to programs offer to our club's journalism institute, visit press.org\institute.

i would like to welcome our speaker and those of you attending today's event. our head table includes guests of the speaker as well as working journalists who are club members. members of the public attend our lunches, so applies you hear is not necessarily evidence that journalistic objectivity is lacking. i would also like to welcome our c-span and public radio audiences. you can follow the action on twitter using #npclunch. after our guest's speech, we will have a question and answer period. i will ask as many questions as time permits. now it is time to introduce our head table. i would ask you to write guests to stand briefly as names are announced. the audience's right, dr. charles schnieeiderman.

a health reported for the great sheet. president of -- and former executor of nasw press. news editor at a medical devices for. a health reporter for associated press. dr. beatrix hamburg guest and mother of our speaker. chair of the npc speaker's committee and a former national press club president. skipping over our speaker for a moment, doris margolis, president of editorial associates health and science communications and the npc who arranged today's program.

thank you, doris. dr. david hamburg guest and father of our speaker. correspondent for reuters news. sarah riordan, biomedical research and policy reporter for nature magazine. anthony -- a member of the national press board of governors and sheep strategy officer and cofounder of social driver. [applause] keeping consumer's faith when they take prescription drugs or eat food or use medical devices or consumed tobacco products -- or consume tobacco products or wear cosmetics or get vaccinated, these are not small tasks, and these tasks fall to the food and drug administration. these products are important to

consumers and to companies and economy, so there can be controversy when the fda plays the role of referee. for instance, we have heard questions such as, our products save enough? if the fda taking too long to approve a new drug or device? for nearly six years dr. margaret hamburg has led the fda as its 21st commissioner. no surprise, the agency has been the target of both criticism and commendation as it has touched a broad range of issues during dr. hamburg's leadership. for example, three years ago, an outbreak of fungal meningitis traced to a compounding pharmacy resulted in criticism that the fda had not provided adequate oversight. on the other hand, the agency's

accelerated vetting process, which has bed drugs to them -- sped drugs to the market faster has been welcomed by families as well as the pharmaceutical industry. dr. hamburg is a graduate of harvard medical school. she has a background in infectious disease bioterrorism neuroscience, numeral pharmacology, and health policy. before her appointment as fda commissioner, she was the senior scientist at the nuclear threat initiative, a nonprofit dedicated to reducing the risk of nuclear chemical, and biological weapons. hamburg will retire next week as one of the longest-serving commissioners in fda history. please give a warm national press club welcome to dr. margaret hamburg. [applause]

commissioner hamburg: thank you. i am pleased to be here. i'm delighted to be joined by my parents and many of my friends and colleagues. this is probably my last formal address as commissioner. i thought it would be a nice opportunity for me to reflect a bit on what i have learned about this agency, and what i really want to communicate to you is how firmly i believe, now more than ever, that this is an agency that is absolutely essential to the lives and health of every american, every day. i think it's hard to overstate, really, the unique and vital importance of this agency for all of us. i confess i didn't arrive at the fda with a fully formed

perspective. i said yes to the job a little early. i didn't appreciate the vast scope of fda until i was actually ensconced in the job. it still amazes me that the products that we regulate account for somewhere between $.20 and $.25 of every dollar the consumers spend in this country. the fda is responsible for promoting and protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, biological products. medical devices, the safety of most of the food supply, the blood supply, and other tissue products, cosmetics, and products that emit radiation. most recently, fda is responsible for regulating the manufacturing marketing and distribution of tobacco products. some things might surprise you about some of the products that we regulate. ranging from things like bionic eyes and replacement body parts

that are made by 3-d printers. to the use of medicinal leeches, that was one that surprised me. we oversee the safety of the food the dignitaries needs at government events, like the state of the union, i just learned last week that we are responsible for regulating the waste that is discarded from moving trains. so you can see that wherever you are, the fda is working for you. but is not just the diversity of the products that we oversee that someone might find surprising. it's the way that we bring our enormous expertise to bear. in this age of skepticism about government, it's easy to imagine fda regulators simply as bureaucrats focused on a narrow set of responsibilities. yet nothing could be farther from the truth. what a remarkable group of

physicians, scientists, lawyers, policy analysts, and other professionals and support staff committed to helping people get the products that they need and count on. i am so happy that some of those fda employees are here with us today. i also was really very struck by the fact that fda employees do far more than just use their knowledge and expertise to review applications or investigate safety concerns. they also undertake vital research to advance medical product innovation and improve food safety. for example, scientists made a crucial contribution to the meningitis vaccine by developing a needed conjugation technology. this vaccine has now protected more than 217 million people from what was a deadly killer across the so-called meningitis belt in sub-saharan africa. fda's food scientists help develop sophisticated genome sequencing technologies to more rapidly identify and stop

foodborne outbreaks. during the gulf oil spill, i was surprised but very grateful when another team of fda scientists developed a new laboratory technique that significantly accelerated the testing process that was necessary for detecting certain oil related chemicals in the seafood itself. that enabled the fda and the state to open up the gulf waters to fishing much more rapidly, it also meant that the rather agitated congressional gulf delegation stopped calling me all the time. so that was really a worthy undertaking. it was also a surprise to me as the commissioner that during that time, i was ordered by the white house twice to go to new orleans and and eat seafood it to show that it was safe.

there are some hardship duties in this job. i want to focus on a few key issues today, issues that i have really been intent to work on since i began, and i believe have really made an important difference in strengthening and reaffirming fda's critical role in american society. i think that most would probably agree that i came to fda at a time when the agency faced considerable difficulties and uncertainties. a series of visible foodborne outbreaks that resulted in disease, nationwide anxiety, and economic disruption. several drug safety crises had eroded public confidence. at the same time, fda was facing serious threats, budgets were signing with economic crisis. a chronic underfunding had already stretched the agency thin in many critical areas and

jeopardize our ability to keep up with inspectional demand, product reviews, and the evolving science and cutting-edge biomedical products, at the very time that scientific and technological discoveries were revolutionizing medical products. fda's challenges were exacerbated by the increasingly global marketplace for the products that we regulate. the importance of fda related products were growing dramatically. there was a series of serious episodes associated with adulterated products coming from overseas, most notably the imports from china obtained heffron, and the melamine laced dairy products and pet foods that cause deaths and serious illness. these effects, and a constant negative drumbeat from our friends in the media combined with the congressional criticism took a toll. public trust was flagging. it was clear there was so much good work going on. as i took stock of the agency, its vast responsibilities and

it's enormously talented and committed workforce, it was clear that fda was at a crossroads. decisions made then would matter in fundamental ways and for a very long time. if fda was truly to fill its mission in the modern era, this was a critical time to reposition in several fairly fundamental ways. to do this, i focused on three priority areas. increasing public engagement accountability, and partnership, reinvigorating our scientific base by advancing regulatory science, and underscoring the need for science-based decision-making, and scientific integrity as the foundation for all that we do. lastly, addressing the challenges of globalization, and it's huge implications for health, safety, and security in the products we regulate. six years later, thanks to an

extraordinary leadership team at the fda and all of the dedicated employees, i think we've seen enormous progress and really important advances. we renewed, expanded, and refined our mission and activities, in important and powerful ways. notably as well, congress has given us important new authorities to regulate cigarettes and other tobacco products, to transform our nation's food safety system with a new function -- new focus on prevention, and to use more flexible and streamlined approach is bring exciting new medical products to patients in record time. to be effective, fda must do its vital work with input from stakeholders and with the trust and confidence of the public. that is why it was imperative to increase transparency, enhance stakeholder engagement, and strengthen partnerships across sectors, disciplines, and components of government. i really think we have. soon after i arrived at fda, we watched an agencywide effort to

make useful, understandable information about the fda more readily available to our stakeholders. this transparency initiative brought greater clarity and understanding as to what we do how we do it, and why for the general public, for industry for patient and consumer groups, and for other key stakeholders. we also worked to increase collaborative efforts, including establishing many important public private partnerships. we enhance our communications, including listening sessions leaders, experts, and advocates seeking ideas and feedback as well as a focus on patient centered medicine. which involves holding dozens and dozens of public meeting with patient advocacy groups for input on specific diseases. with stronger stakeholder engagement, there has been much better information sharing, more predict ability, and ultimately

a better process and product for the people we serve. my second priority, science, really builds on and reinforces the efforts just mentioned. as a science-based revelatory agency, our credibility and success depends on our ability to deliver on the promise of science through smart, data-driven decisions that benefit patients and consumers. smart regulation also requires the ability to respond to changing situations, new information, and new challenges. we cannot have a one-size-fits-all approach, but we always must bring the best science to bear. it requires that we advance regulatory science. the knowledge and tools necessary for the meaningful and timely review of products for safety, efficacy, quality, and performance. and to inform him more efficient product of element process as well. building on greater understanding of the underlying mechanisms of disease and human

biology, a robust field of migratory science can help us leverage opportunities for innovation and more quickly bridge the gap between scientific discovery in the real-world products that will make a difference in people's lives. advancing regulatory science has been a huge priority, not just within the walls of fda, but as an active, dynamic field of scientific research, we are continually working to find new and better ways of doing things. to seize the opportunities of existing science and technology, and to work with industry and our scientific partners in academia and government in a collaborative way to discover and apply new regulatory tools. but what does this really mean? we've taken critical actions that will improve the safety of food americans consume for years to calm. importantly, the development of science-based standards to create a food safety system focus on preventing foodborne illness has been key, thanks to the passage of the food safety modernization act as well as new tools to help us in the

detection and rapid response to outbreaks, as i mentioned earlier. i we've taken significant steps to make americans make more informed and helpful food choices, including working to reduce trans fats in processed foods, more clearly defining when they could foods and other foods can be labeled gluten-free, updating nutrition labels based on current science, and finalized new rules to make calorie information available on chain restaurant menus and vending machines. some of you may be asking where is the science there? believe me, and my deputy for foods no, these areas are based on sound and current nutrition science, and involve some very complicated analyses. turning now to the medical product in maine, we are pursuing such things as enhancing the use of

pharmaceuticals and qualified biomarkers, developing innovative critical trial designs which enable critical studies to be -- clinical studies to be more effective. and to effectively mine large databases to learn more about the issues. as well as such things as how can we identify populations of responders to a given treatment based on certain indicators. these efforts matter in our ability to swiftly and shortly review product applications that come before us. they are also essential for reducing the time and cost and increasing the likelihood of success in the product development process itself. in the ecosystem for biomedical product development, fda plays a critical role. because we more fully understand what it takes to translate a

good idea into a product with demonstrated safety, efficacy, and quality. and a product that can be scaled up and reliably manufactured. simply waiting until we see what comes through our doors cannot be the going model. fda is uniquely situated to examine important unmet medical and public health needs, and how they match up with what's actually in the development pipeline. indeed, a growing part of our focus in recent years has been to try and identify what is in the development pipeline provide guidance and incentives to address gaps and to accelerate progress, and to foster the kind of innovation that will make a real difference for patients. also, we've seen how early in continuing engagement between the fda and researchers in the product development plan makes a huge difference in streamlining the process and making sure that

the right questions get asked and answered from the very beginning. as you may know, we have now in place a number of expedited review programs that help to speed the development and availability of medical products that treat serious diseases. for prescription drugs, we have fast-track, priority review, accelerated approval, and now thanks to recent legislation, we have the breakthrough therapy designation. we are seeing both development and review times increased significantly with exciting new therapies entering the marketplace much sooner for the patients who need them. last year we approve the most new drugs in almost 20 years. and more orphan drugs than ever before. 41% of these new drugs were first in class products, resulting in a breathtaking array of truly innovative new therapies for patients, and the majority of these new drugs were

approved using some kind of expedited pathway. today, contrary to what many would say, fda approved drugs faster on average than all other advanced nations, and the vast majority of the time, the u.s. is the first country in the world to approve important and novel medicines. and substantial improvements are being made in the efficiency of medical devices used as well. moreover, we have accomplished this while remaining the world's gold standard for safety and effectiveness. yet we all recognize that despite the successes, too many diseases still await treatments and cures. serious public health needs, such as treatments for all timers disease -- all timers disease -- alzheimer disease are not being met. people suggest that fda's authority and procedures be found mentally reconsidered. i strongly disagree. in actuality, regulation, when done right, is not a roadblock.

it's the actual pathway to achieve meaningful and lasting innovation. smart, science-based regulation this instilling consumer confidence in products and treatments, it levels the playing field for businesses. it decreases the threat of litigation. it prevents recalls that threaten industry reputation and consumer trust. not to mention levying huge preventable costs on individual companies and in fact, entire industries. and it spurs industry to excellence. the fact is, when done right smart regulation allows us to deliver on the promise of science in the service of patients, consumers, and yes even industry. it is foolish and dangerous to believe that reducing regulatory standards will make new treatment intervention appear if the science is not there. alzheimer's disease is a good

example. i've heard comments that something must be wrong at fda because we are not approving as many drugs for alzheimer's disease as we are as cancer. but the reality is that -- is not the problem of unnecessary hurdles, but rather for the need of medical research to increase our understanding of the underlying disease process, and natural history of the disease and where are the best targets for therapeutic development. we are working closely with the all timers disease research committee -- the all timers disease -- the research community. we hope that in fact we will see meaningful progress soon. of course, there are sometimes tensions between moving new, potentially promising products quickly out into the marketplace and making sure that they have

inadequately studied. as fda commissioner, i have been surprised by how many people ask whether i favor safety renovation. in fact, mi confirmation hearing, now quite a while back, i was really, i guess a bit of an unknown commodity to both the consumer and patient groups, and industry. they were trying to figure out what perspective i would bring to this new position. i was surprised to learn that someone supposedly went through and counted how many times during the course of the hearing i said safety and how many times i said innovation. this was supposed to be a measure of whether i was going to be consumer friendly, or industry friendly. i'm told it was actually about equal. i never went back to actually check. i certainly don't believe that the two are mutually exclusive.

why should we have to choose protecting the public health while encouraging, not discouraging, innovation must be the goal? for us at fda, it is. innovation is only meaningful as it makes a real difference, a positive difference in the lives of patients and consumers. that's why we must have standards and science to assess the benefit and risks. when comes to the treatment of disease, we must understand the broader context of use, the nature of that specific disease or condition, the other treatment options, and such things. we must also better understand the patients experience of the disease and its treatment, their perception of the risks and benefits, and of course, their willingness to accept risk. the balancing of risks and benefits is absolutely fundamental to the fda's role. it's always a challenge. we joke at the fda that we have only two approval speeds, too

fast and too slow. we are perceived to approve allies to quickly when a significant safety is identified once the product is in widespread use. on the other hand, we are to slow when a drug that has undergone a lengthy development and review is finally approved and provide the real therapeutic benefits. it's a hard task, but the challenge for fda scientists is to strike the right regulatory balance. i also want to speak briefly about the importance of striking the right balance between fact access and good science. in a race for the newest treatment, we must remember that innovation doesn't matter if the product doesn't work. i can't emphasize enough the critical need to maintain the standards of safety and effectiveness for medical products in this country. it wasn't that long ago that companies were allowed to market drugs without proving that they

were effective. we've only got to look back at that time to see the devastating consequences for patients and for medicine. drugs were marketed for thousands of unproven uses. most of them unsupported by adequate research. when in the mid-1950's, congress gave fda authority to require evidence of effectiveness, i 80% of the drug uses the companies were promoting turned out to be ineffective. many of them were also dangerous , for example, before companies had to show that their drugs worked, drug companies widely promoted powerful toxic antipsychotics like thorazine for low-level anxiety. and there was little or no incentive to conduct those research is necessary to find out what were true medical advances. most promotion was based on unscientific studies, or no studies at all. it's important, i think, to understand that fda strongly

supports responsible to medication of scientific information. but we do not support an approach that will harm patients or undercut the incentives for the necessary studies to be done to prove that a specific use of a drug product is both safe and effective. history has shown that patients have been harmed when physician reliance on preliminary or incomplete scientific information regarding unproven uses. history is also shown the enormous patient benefits that results when i sponsor conducts rigorous clinical studies and demonstrates that a promising medical products is in fact safe and effective in treating a serious disease or condition. fda's objectives, to strike the right balance between respecting the usefulness of communicating scientific data in certain circumstances on the one hand, and preventing harm to the public on the other. we must not forget that the

great leaves forwarded evidence-based -- leaps forward with evidence-based methods after a series of disasters involving unsafe and ineffective medical products. the standards have boosted the confidence that americans place on medical products, the world places on the american medical byproduct industry. we must move forward, not backward as a nation. and embrace the opportunities of cutting-edge medical advances and the promises they hold for public health. i want to talk about one other important issue, it's been a priority, globalization. when fda was first established are related industries were predominantly local and the volume of imported products was very low. today, however, other nations increasingly produce in whole or

in part, the food and medical products that american consumers and patients use in their daily lives. nearly 40% of finish drugs americans consume today are made elsewhere, and 80% of the active pharmaceuticals in those drugs are manufactured outside our borders. for the food supply, the numbers are equally startling. more than 85% of seafood that the new here comes from other countries. about 50% of our fresh food and 20% of our fresh vegetables, and these changing dynamics off lucy -- obviously introduce new complexities, new risks for american consumers, as these products follow increasingly complex global supply chains to get to your table. in your kitchen cupboard. we can no longer rely on simple inspections at the border to track the products that are coming through. the volume has quadrupled over

the last decade. we have introduced new high-tech risk-based screening systems of the borders to allow us to target on the most vulnerable commodities, the ones with the highest risk. we really have to step beyond our borders to the places where these products are being manufactured. processed, distributed. that has caused us to have to undertake a whole new shift in how we do business. we now have foreign outposts around the world to be a hub for inspections and for collaboration. with industry counterpart regulators, and other stakeholders. we are working closely with counterpart regulatory authorities to harmonize standards, to share information, and in fact, to share the workload of inspections and assessments.

of the products that we are all struggling to regulate in a globalized world. we are working together with other organizations, and nations, to try and actually build regulatory capacity in many of these countries with very immature systems, but where an increasing volume of products are coming. and being consumed by americans who expect the same standards in the products they are taking wherever they had come from in the world. so that has been a major focus of time and attention. i think it represents a huge and underrecognized area that challenges health safety and security in our nation. so i think that, though i got lots more that i want to talk about, i think that i have gotten the indication that i ought to be winding down. so with that, let me just make a couple of points. one is that fda is a unique and essential agency. that has a set of roles and responsibilities that are not

done by anyone else. if we can't do her job and do it well, there is nobody else to backstop behind it. moreover, we are regulating products that are so important to each and every one of us every day and to the health of our nation, our nation's economy, and in fact, our global economic competitiveness. as i look forward, i worry, fda has constantly been underfunded with responsibilities that outstrip the resources we get to do our job. if you look at what cost every american in this country to support the services of fda, believe it or not, it's eight dollars for americans for a year. i suspect some of you may spend more than that starbucks later this afternoon, and yes, we regulate starbucks. [laughter]

as i stand here, not only concluding my remarks, but concluding my tenure there is seen as fda commissioner, i really am proud to be able to tell you that fda is a stronger, more engaged, more effective agency, better positioned for the challenges of the 21st century. we are an organization that embraces smart science driven regulation, we are an organization that understands in the modern world the importance of partnership, we have a wonderful mission and an extraordinary group of employees . we have the challenges before us, and we do need your help and support so, while i will not be present any longer, i do want to leave you with this fact that the fda as a public health agency essential to the health of all of you, we need to strengthen it, rather than

weekend or undermine it. and to do so will require support and partnership of all of our stakeholders, and every american who uses fda regulate products is a stakeholder. i look forward to watching that vital collaboration amongst all of the stakeholders, just seeing the work of this relatively small in size, but truly mighty in purpose agency, be both appreciated and supported. thank you. [applause] moderator: thank you, dr. hamburg. you mention striking the right balance. when it comes to approval of products and devices, and from the experience of your tenure, what percentage of the

time would you say that fda got it right, and what percentage of the time did you realize that we didn't do our job there, and maybe we should not have let that one out? commissioner hamburg: that is a very hard question to answer and to quantify would be dangerous task. one of the things that's important to understand is that we are dr. hamburg always having to make decisions with partial information. because when you are doing the study before it drugs actually approved, you can learn a lot. and if the drug really works and really reflects a good match between the target of the drug and the underlying mechanism of the disease, you will know it quickly as the decision would be obvious. with many things that don't work quite as well, it would be almost impossible to know everything about the drug.

then even the things that actually are extremely effective, you still can't know everything about them. in the context of a preapproval developments. it's when they go out into the marketplace and they are used by many more people and are used by people with other coexisting diseases and taking other medications etc. that you begin to learn a whole lot more. that's why fda has a lifespan approach to the regulation of drugs. we continue to monitor drugs after they have been approved, post-market surveillance and sometimes by requiring those market studies to collect more information. in my view, people are quick to jump on us if a safety issue emerges, in the post-market setting. they think it's a failure of the system, someone had to admit a mistake, but i think we know that everything has risks, and

that the nature of the process is that some of those risks will emerge when many more people are taking the drug, and it's more complex settings. so i think that when we can detect it early, and make the determination about how to address it, whether we need to change the indications for use whether we need to actually recall it from the market, or whether we need to provide additional warnings, all of those things are possible. in all of those things are part of the comprehensive regulatory process. moderator: you mention several things that you are proud of about the agency, what would you consider the number one contribution that you have been able to make to public health in your tenure? what is the one thing he would talk about couple years down the road when you're talking about your service, that one thing you are most excited about. commissioner hamburg: that's an

impossible question, number one. there many things in many different arenas given the scope of our responsibilities, it's unfair to even ask. [laughter] you think about the many different ways that you can answer the question also. if you mean in terms of potential impact on burden of disease, i would say we hadn't realize the potential yet. but the new authority we had to regulate tobacco clearly is historic and transformative. tobacco products remain the leading cause of preventable death in the country. and frankly around the world. and with the new tools we have over time, we will be able to make a profound impact on health and well-being in this country. and as regulatory authority, a fairly unique regulatory

responsibility over tobacco, we also i think are showing the way for many other countries around the world. and the global burden of tobacco-related disease. moderator: a couple of different questions on what you think of the 21st century cures initiative in congress to overhaul health care industry regulations? commissioner hamburg: i think we all can agree that this is a critical time to really look at what can be done to really leverage the opportunities in science and technology today to ensure that we dr. -- are developing the safest best, most innovative and effective medical products. for people who need them. that's the goal of 12 first century cures. we are sort of in a golden age for this undertaking. we want to make sure that all of the parts of the biomedical products ecosystem are aligned towards that goal.

i do think it needs to be approached in a very thoughtful and careful way. because many of the things that need to be done perhaps are not best achieved through legislation. i think for us, there certainly concerns about issues that i touched on in my remarks, of the misperception that you might be able to speed innovation by lowering standards for safety and efficacy. we think that would be a terrible mistake and ultimately would not just damage patients but would damage industry as well. we also are concerned that through this process, we might be given what we call in washington unfunded mandates, or we would be asked to take on a set of new tasks, but there wouldn't be adequate resources to go with it. that i think would not only be

difficult for that specific activity, but would have ripple effects on other important regulatory activities are really matter to patients and consumers. moderator: what if any steps is fda taking to ensure treatment and labeling of nutrition's in vitamins and nutritional supplements given recent findings on walmart shelves? commissioner hamburg: we have authority to regulate dietary supplements. in a limited set of activities many people in this country think that the fda regulates dietary supplements in the same way that we regulate prescription drugs, there's a preapproval process. but we do not. we oversee and have the authority to ensure good manufacturing practices at their

plants, there's a requirement that they report serious adverse events to us, and we do regulate claims that they make, and we find a product that has been approved drugs, for example, that shouldn't be there, steroid or a viagra like compound, the frequency show up in dietary supplements. then we will take action. i'm not familiar with the specific walmart case, i will have to defer. moderator: there have been concerned that the medical device approval process is too lax. how do you feel about the process now, and have you felt political pressure to accelerate product approvals, and what changes need to happen to that product approval process? commissioner hamburg: medical

devices have a different regulatory pathway than drugs. for some of the points i dr. was talking about, in terms of the different perspectives that people have on fda, too fast or too slow, too lax or too stringent, applies with medical devices. the majority of medical devices that fda oversees are what are called 5-10 kay's, not the highest with devices with the middle category of devices. there are very limited requirements for new data to be generated as a part of that approval process. you need to demonstrate that your product is similar to an existing product in the marketplace, using a predicate mechanism and some people find that just totally lax and inadequate. to assess a changing device

array over time. others think it's more than enough, they would like to see even the standard that currently exists relaxed a bit. it's one i have been fascinated with during my tenure as commissioner to see the differing responses and i think that we need to continue to look at how we regulate devices because the world of devices is getting increasingly complex on one end and then there's a set of other devices that really don't need much attention. i think this is an area where i don't know that the u.s. has gotten a completely right, i do know that the european union has gotten a completely right, i think it's an area that we need to continue to learn more about

and i think that we are encouraged by some of the activities, partly through public-private partnerships that have developed, to look at innovative strategies to do research that's necessary to better assess devices through a recent new requirement for you need device identifiers on devices, so we would be able to track devices and their use in the post-market setting more efficiently. and learn a lot more about risks and benefits. i think it's a dynamic area. moderator: had a few questions come in on the relationship between the agency and it those the regulates. this questioner says that within the ranks of the fda, there are many scientists and administrators who have served at the agency for decades, and one of the criticisms is that the leaders become too cozy with

industry after working for years with the same officials, well fda obviously strives to retain its best staffers, is the risk that staffers can overstay their welcome and this problem creeps in? commissioner hamburg: again this is one of those areas where different people have very different perspectives. some people believe that there are lifers at the fda that have no use for industry, and are always skeptical. and then there are others who worry about the issue you were describing. what i would say is my experience at the fda, which is now almost six years, is that the employees who work there have just remarkable commitments to their jobs, and the highest integrity, scientific and personal integrity, we obviously operate in a framework where there are very clear conflict of

interest rules. very clear requirements about how certain kinds of interactions are structured, and i think that we need to work in partnership with industry because we are regulating the product that they make, and we need to understand those products. we need to have a full and open exchange of information. in many instances, there is great value in having industry academia, and government actually worked together in shaping research in critical areas. i think people sometimes get worried about that. but we do it in a way that clearly defines us as free competitive research, not a collaboration where there is a particular product that's being

developed where an fda scientist might be working in the partnership. but it's where information is being developed that can be applied across a whole category of products and help us to advance our knowledge and develop a regulatory tools that are needed to advance our ability to do adequate and full reviews of the products. and to enhance product development. moderator: you have been a champion of advocating sodium reduction. the majority of your statements reference what pressure benefits of lower sodium consumption. however, some recent studies cited by this questioner including one by the iom have suggested that low sodium consumption for healthy individuals can lead to significant health problems.

another article found that for healthy people, there is no or very minimal blood pressure impact from sodium reduction. the questioner is saying that the agency needs to reevaluate what it says on sodium and is there any examination of shifting the view? commissioner hamburg: this is been a topic of ongoing discussion, i think that clearly there have been some recent studies that have raised some questions, there have been individuals who have obviously been representing that position over time. i think the body of evidence does really demonstrate a linkage between sodium in the diet and negative health consequences. and that americans' diets on average contain a very large amount of sodium. most of that sodium is in

processed foods where we as individuals consumers really can't control our exposures in terms of what is in that food, is not the salt shaker where you can control it, it's what you are eating. so we feel that we are providing very important information to consumers through things like the nutrition facts label, which enables you to know what is in the product that you are eating. and we do things that there is clearly, a very positive health benefit by trying to bring down sodium levels in the american public. moderator: got a couple of questions on biosimilars.

i will try to combine them because we are running short on time. when questioner wants to know how you envision this new area of copycat versions of biotechnology drugs playing out in the u.s. marketplace, the other wants to know if devices such as generics in bio similars may actually discourage the development of lower-cost options for the public? commissioner hamburg: bio similars are biological molecules that are similar to existing biological therapeutics that are innovative drugs in the marketplace. they have a parallel relationship to generic drugs and innovative drugs. they are much more complicated molecules in terms of their size and how you make them. in the human response to them. it's a much more complex process than just generic chemical tablets. we've only just recently approved her first bio similar which was an exciting event for

us. the pathway for bio similars actually is relatively new at the fda. it was part of the health care reform act, the aca actually. one of a few things for fda to was embedded in that larger piece of legislation. we imagine that these drugs will be available to the public at much lower cost than the innovative biologics, which are very, very important drugs in medical practice, they make huge difference in the lives of many patients, but very very costly. it remains to be seen whether some of the most optimistic estimates of cost savings will really be true, but if we can help make important therapeutics available in a more accessible way, i think overall in terms of the american health care system,

that would be a huge benefit and the fda role is to assure that these bio similars can be used in these patients in a manner that is safe and effective. moderator: could you update us on the current listeria problem? we are interested in any specific foods or brands involved in recalls. commissioner hamburg: we have a couple of listeria problems. we have listeria in bluebell cream, which in resulted in several deaths in a kansas hospital. and there was a listeria outbreak in spinach but i when companies did a voluntary recall after finding listeria. i don't know that there's much more it i can say other than it's a powerful reminder that foodborne illness is very real

in this country, and it can be low-grade, where you get sick and have a few days off from work, one in six americans suffer from foodborne illness every year. but it also does results in many, many hospitalizations and deaths each year in this country. we are in the midst of implement in the food safety modernization act, which is a historic opportunity to transform her food safety system from one that is reactive, where you respond after albert occurs, to one that puts the emphasis on prevention, and understanding where the points of vulnerability in the lifespan of the product are, and how can you shore up those risks so we can prevent problems from occurring in the first place. i hope that we will come as we implement the food safety

modernization act, be able to report fewer listeria and other foodborne illnesses, but in the meantime, i think one of the other things that striking about listeria outbreak so we've been seeing is that we are seeing listeria in certain food products where we hadn't seen it before. so it also is a reminder that microbes can be unpredictable, they can take up new homes, and that we have to always come back to the best strategies for food handling and hygiene, and the implementation of the food safety modernization act to prevent problems from occurring. moderator: i will ask you one more question. i wanted to remind our audience of our upcoming speakers. on tuesday, john cosper and will speak to us. on april 7, a best-selling author and outspoken critic of radical islam will address a luncheon.

on april 16, ban ki-moon secretary general of the united nations will speak. second, i would like to present you with your national press club mug, which is perfect for enjoying fda approved liquids in. [laughter] commissioner hamburg: we do regulate some forms of ceramics as well. [laughter] moderator: wouldn't you know it. the final question dr. hamburg as you were named one of the world's 100 most powerful women by forbes and 2014. what do you think our country can do to encourage more young women to pursue careers in science, technology, engineering, and math? in other words, to follow in your own footsteps. you have less than two minutes to answer. commissioner hamburg: i think it's really important, we need to start early, we need to have exciting engaged, knowledgeable teachers in our teachers -- in

our children's schools. have to help with mentoring, career pathways, and we have to make sure that there are good jobs for women at the fda. we have a very strong representation of women in our scientific and leadership teams. i have been proud to be at the helm. moderator: ladies and gentlemen, join me in thanking dr. margaret hamburg. [applause] moderator: i would also like to thank the national press club staff, including its journalism institute and broadcast center for organizing today's event. if you would like a copy of

today's program, or to learn more about the national press club, go to our website, press.org. thank you very much. we're adjourned. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org] [captions copyright national cable satellite corp. 2015] quick senator harry reid announced it will not run for reelection after 30 years in the senate. senator reid made the announcement in a video posted online. senator reid: these bruises i have are in inconvenience, but they are nothing compared to the

bruises i got when i was fighting in the ring. when i was a boy, i dreamed of being an athlete. i listened to those games on the radio, baseball games, and i envisioned me as a man out in centerfield in yankee stadium or fenway park in boston, but the joy i've gotten with the work that i've done to the people state that has been just as the filling as if i had played centerfield at yankee stadium. the job of minority leader, and the united states senate and is just a support as being majority leader. it gives you so much opportunity to good things for this country and that's what i am focused on. but this accident has cost us for the first time to have a little downtime. i have had time to ponder and sink. we've got to be more concerned about the country, the senate, the state of nevada, then as. then us. and as a result of that i am not going to run for reelection. my friend senator mcconnell,

don't be too elated. i'm going to be here for 22 months. and you know i'm going to be doing? the same thing i've done since i first came to the senate. ♪ we have to make sure that the democrats take control of the senate again. and i feel it is inappropriate for me to soak up all those resources on me and i can be devoting those resources to the caucus, and that's what i intend to do. a decision that i've made has absolute nothing to do with my injury. it has nothing to do with my being minority leader, and it certainly has nothing to do with my ability to be reelected because the path to reelection is much easier than it probably has been for anytime i run for reelection. >> i get upset sometimes when i hear optician say that they're going to go and spend time with her family after they decide that they are not going to be in politics anymore.

he's a wonderful husband and a wonderful father. so that's been more important than the other things that he's done with his life. senator reid: somehow with my background, my upbringing to have the experience i've had is really a miracle, i don't want people in the state of nevada to know that i am so grateful, and i have done my best. i haven't been perfect but it really tried my hardest to represent the people of the state of nevada. ♪

>> at looks like chuck schumer is likely the next senate democratic leader. senator reid has endorsed senator schumer as the for the post. senator durbin has said he will seek to remain in the number two spot and support senator schumer for the top job. democratic congresswoman tammy duckworth is reportedly going to challenge mark kirk here in illinois. she will make a video announcement monday about her campaign.

here are some of our featured programs for this weekend on the c-span networks. on book tv, saturday, peter wallace and says government housing policies caused the 2008 financial crisis and it could happen again. sunday, director of the earth institute jeffrey sachs on a plan to tackle issues like poverty and environmental decay. on american history tv, a discussion on the last major speeches of abraham lincoln and martin luther king junior. sunday the 1965 meet the press interview with martin luther king jr.. find our complete schedule at c-span.org and let us know what you think. e-mail us at common set

c-span.org. send us a tweet. join the conversation. like us on facebook. follow us on twitter. >> a senate hearing concerning alzheimer's disease and then negotiations on iran's nuclear program. and then commissioner margaret hamburg remarking on the agency's accomplishments. >> medical researchers discuss where they are in terms of developing a cure for alzheimer's disease, the effectiveness of current treatment, the need for more funding. the committee heard from former model dee smith