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Risks. He spoke in washington, d. C. , for about an hour. Good morning, everyone. Not much going on in Health Care Policy these days, is there . My name is topher spiro. I have the pleasure today of introducing congressman pallone who has been a leader in protecting the integrity of the medicare guarantee and medicaid program, making the nations food system safer, strengthening laws to keep our air and watter cle clean. Making health care more afwordable and accessible many and supporting initiatives that advance the public health. Mr. Pallone is the Ranking Member of the house energy and commerce committee. Which has jurisdiction over issues pertaining to energy, environment, commerce, telecommunications and health care theres a lot on his plate. From 2006 to 2014 he served as the top democrat on the subcommittee of health and as chairman during the 111th congress. He played a key role in authoring and passing the Affordable Care act. Please welcome congressman pallone. [ applause ] thank you, topher. I want to thank the senate for American Progress for hosting us today. I have to say a few more thins s first of all, right now during the Health Care Debate and the republicans effort to repeal the Affordable Care act, cap has really done fantastic work in my opinion in educating people about the negative impacts of the republican repeal. Your twitter is it part of that as well. Theres so many things that the center is doing, that are being helpful. I often felt for most of the time after we passed the aca, there wasnt a lot of information going out to the public about the positive effects of it. In the last six months, thats changed dramatically to the point where very few americans jonathan, thats about the same level of favorability as our governor as you know. About 15 of the people view the republican repeal bill in a favorable light. I think that has to do with the center and other organizations out there pointing out the negative impact on the American Public and their Health Insurance. Also i mentioned when i came in, i remember, i think it was in the fall of 2015 when the center put out the report about drug pricing and the high cost of drugs. That played a major role, i think in Hillary Clintons comments and ultimately trump as well about how the high price of drugs needs to be addressed and was a priority mentioned many time tim times during the campaign. Im going to talk about drug pricing in my comments. After we sit down and topher starts asking me questions, well talk more about the aca. Obviously, i believe that what senator mcconnell is doing these last couple weeks, the changes initiated by senator cruz and others are cosmetic. If anything, they make the bill worse. Most notably, the cruz provisions that allow Health Insurance companies if they enter the marketplace to also then offer junk plans outside the marketplace. That wave the essential benefits package. 2 was bad enough when the senate bill said states could wave the essential benefits package now the cruz amendment and the latest mcconnell proposal lets it go beyond that. Even without the states waving it, the junk plans could be offered in more states. Even those that dont wave them. Well talk a little more about it. The main thing i wanted to talk about today was drug pricing, last week on the floor, we pass ed reauthorization of the fda user bills, that was for drugs and medical devices and generics, that is now the going to the senate, we expect them to take it up fairly quickly. Thats my hope, and that bill is going to help with generics, generics in my opinion are a major way to deal with drug prices effectively, the main thing that i want to stress today, the problem with drug pricing is getting worse, not better. Even though cap talked about this two years ago, even though it was part of the president ial campaign on both sides of the aisle. Even though President Trump continues to mention it from time to time, congress and the administration are not doing anything effectively about it. We have repeatedly asked our Republican Leadership on the committee to have hearings. They havent said absolutely no, but there still havent been any hearings. Not only are we not addressing this legislatively, were not even having hearings on it. We did when we passed the fda user fee bills in committee, pass a sense of congress resolution, which was done by voice vote. The committee should address drug pricing. But, you know so far you know congress. They dont have any force of law, at least they indicated they do care on the republican side, we havent set any action. Were still going to push them. So the problem is not only is the problem with higher drug prices getting worse. Not only is it outpacing other increases in health care significantly. Next year annual drug spending is expected to reach 500 billion in the United States. I can see the point, i dont even know if were there yet. At some point well probably get to the point where drugs are the majority of your health care costs. I dont think were there yet, but we could easily get there, as a result of those high prices, Many Americans face real barriers in terms of getting a medication they need. Which is why this is such an important issue. And it shouldnt be a partisan issue, we had a poll that Kaiser Family foundation released just this may, that said that 6 in 10 americans said lowering the cost of prescription drugs should be a top priority, that was democrats and republicans, when you talk about republican americans, not the people that are elected or the leadership here, just republicans in general, they feel its just as important as democrats do, which is probably one of the reasons that President Trump and Hillary Clinton talked about it during their campaign so what can be done . Let me talk about what can be done. Its complete. Some of these things are easy, talking about negotiated prices, that may sound easy, a lot of these things are more complex. I want to stress theres no Silver Bullet. The reason im mentioning a lot of Different Things, i dont think one thing alone is going to accomplish the goal or be a solution. That shows you the bureaucratic aspect of it here, this is the problem where brand Name Companies cause delay bringing generics to market. They use the rems to block access for samples of branded drugs. If the generics are going to come to market, they have to have samples of the brand name drugs. The rems program is often used by brand names to prevent that. Think dont provide the samples, you might say, is that a big problem . I think its a big problem. There was a july 2014 study conducted by matrix Global Advisers that said the ongoing use of rems cost the u. S. Health system 5. 4 billion annually. Theres probably a lot more today. So we need to provide a way of reducing the ability of the branding companies to block generics coming to market by providing access to the samples, and theres a bipartisan bill called the fast generics act that was introduced by peter welch and i forget the ready sponsor, it is bipartisan. This establishes an fda approved authorization process for generic and biomanufacturers to obtain samples of these branded products. That was something we considered during the fda markup, but it wasnt passed. We couldnt get the votes for it, we need to obviously the other thing deals with exclusivity. Some of this is going to be a little in the weeds here, i guess thats why were at the center, they get into the weeds. Exclusivity, of course, we have a process where brand names can only sell the drug. The exclusivity protects certain drug treatments from competition for a set period of time. But today drug manufacturers office retain that incentive even if theyve violated a criminal or civil law. One simple thing is to say, if you do that. Promote the unapproved use of a drug treatment. Then i think they should lose the right to exclusivity for the related products. Basically, punishing bad actors if you want. Thats the second thing i wanted to mention. Penalties for misclassification in the medicaid drug rebate program. You pay a lot. I guess you get a larger rebate, right . If you classify your product as generic, and but a lot of times we have situations where a drug company has misclassified their product as generic. And by doing that, they make a lot more money. Because they get a larger rebate. The best example of that is the epipen many. It had been classified as a generic drug and that meant they got the change was with basically they made more money. There was a settlement, which a lot of people think was inadequate. As a result, they had to pay back. I forget how many millions of dollars. 1. 27 billion is what we estimated the cost. What wed like to see is stronger penalties. So that companies have a disincentive to do the wrong thing and misclassify their product. Fourth item, the most significant and the one that you hear about the most is the medicare price negotiation, we have price negotiation with the va, with the military. We dont have it with medicare, we should give medicare the ability to negotiate prices with the Drug Companies. Thats an easy one. Its easy to explain. And President Trump during the course of the campaign and since then has said he would like to see that. The Congressional Republicans continue to oppose it. The hhs secretary is restricted from having any role in negotiating or setting prices. The first thing we would have to do is repeal that noninterference clause, so the secretary could do that. And then there are other aspects we can go into, i dont want to spend too much time that was medicare, with regard to medicaid. Medicaid, what we really need to do there, medicaid is state and federal match, right . And so the federal government if a state decides they want to negotiate prices they can. There are ways for the federal government to help them do that. Were suggesting we create a federal state medicaid negotiating tool for high cost drugs. Drug manufacturers want to sell the drugs to state medicaid agencies have to enter into rebate agreements with the secretary. Many states have tried to joining together. And cms does not have the authority to facilitate those negotiation negotiations what were suggesting is that we authorize cms and participating state Medicaid Programs to partner to negotiate supplemental rebates from drug manufacturers. Well call it a medicaid purchasing pool. That essentially would require legislation as well. I want to talk about generics in the Medicare Part d program, and the way we can provide greater financial incentives for gene c generics, in the fda user fee legislation. We did incentivize more generic competition. We did that in the user fee bill. If you want to talk about more of that, we can. There are ways to provide more financial incentives for generics, and also the rems that i mentioned before. So what were suggesting here is first of all, improvements to the part d appeals process, because a lot of people are turned down, and then they appeal, they dont know how to go about it. We have to simplify the process so seniors or the disabled dont abandon hope that they can take an apeople. We also can offer the lowest possible co payments. Right now, under Medicare Part d, weve been trying to keep the generic co payments low, and thats saved a lot of money. But its been much more difficult to do that with the low income subsidy, the lower income population, a lot of them, theyre the ones theyre the Medicare Beneficiaries that have the highest drug spending. Theyre co payment amounts of set by statute. That means that part d plans cant lower co payment amounts on their own, to encourage the use of generics as part of the program. What we would have to do is need legislation or pass legislation so that we can lower the generic co pay. Irmentioned the appeals process as well. I want to talk about a couple more medicare improvements we can make. And then topher will go to the questions part. In terms of additional medicare improvements, one of the things we can do is close the doughnut hole. We closed the part d doughnut hole over a time. That hasnt ended yet about theres still part of the donor hole that needs to be filled. I would suggest we do that two years sooner. We can reduce costs for seniors and the Medicare Program by tieing reimbursement to the most common dosage of drugs. This doesnt really relate to the opiate problem but the fact that a lot of times people would get a lot of pills, right . And they would sit on the shelf and other people would use it. What we do see is that drug manufacturers package drugs in the viles that contain too much of the drug. Youre getting more prescription drugs you dont need. Its billions of dollars, apparently. What we can do is incentivize Drug Companies to match the need of the population, that could be done by legislation as well. So and the last thing i want to talk about is transparency and accountability of Drug Companies and their prices. We have some good actors, one of them is in my district. Both johnson and johns and sanofi disclose their drug prices every year. This is an important first step, but theyre doing this voluntarily. Theyre the only ones doing this as far as i know. For the past two years of the obama administration, they set up a medicare and medicaid drug spending dashboards that provided an online tool where the public could view drug spending. And it wasnt perfect, but its obviously an effort to create transparency. And what were what i would say, is that the Trump Administration should continue this. As far as i know they havent, but they should. Because without the dashboards it would be difficult to get that Information Congress could take steps in the medicaid drug rebate program, if a manufacturer increases the price of a covered outpatient drug significantly. They basically have to report it. I would advocate that as an important step legislatively. I mean, obviously, if were going to deal with drug prices, we have to have the data as to whats actually happening with the increases, otherwise its more difficult for us to address it. We have this in other parts of the health care system. So its not that unusual to see Something Like that. The last thing i wanted to say, and well have topher come back up here, a lot of these initiatives are things im going to work with with our committee members, both democrat and republican. Try to develop comprehensive legislation. Things that would be most effective and politically more viable. There are other things out there that may be less effective or more difficult to do politically. Thats why i havent mentioned them. I dont want to suggest these are the only things. The main thing is, we need to come up with Workable Solutions to address drug pricing, to incentivize competition and encourage the development of affordable drugs. These are some of the steps we could take in that regard, and that well work on when we come back in the fall. So topher, you want to come up here . What are we doing now, you are going to ask me questions . Were going to have a little dialogue . Well, i think i want to say first of all, that i think its incredibly important that democrats have a proactive positive agenda for reform, we cant just be about opposing trump care, cant just be about russia. Its not how were going to win the election, right . I dont want to talk about russia. So we thank you for your initiative and all your work. I really think the center played a major role in this debate with their report that came out a couple years ago. Thank you. It really was sort of the start of washington thinking about this, i think. One thing you said that i wanted to ask you about, i found interesting. Was when you were talking about Committee Hearings for the drug user fee legislation. And it were going to end up having had more Committee Hearings on that legislation than on trump care. And youve been in congress a long time, right . Almost 30 years. I shouldnt mention it, but i will. Have you ever seen such a slap dash secretive process in your entire career . Let me say this, its funny, because i dont know what the circumstances were, but in the last couple weeks, i spoke at one of our energy and commerce hearings and a couple of the republicans said, here comes regular order guy. They literally called me that, somebody did, i dont remember who, thats what ive always been. I guess i got that from john dingell, we always should have a subcommittee hearing, a subCommittee Markup, a full committee hearing, a full Committee Markup before we go to rules on the floor. Thats regular order simplified. It seems like were getting further and further away from that to the point where i guess in the house, when they did their repeal, they had a full Committee Markup, nothing in the subcommittee, i dont think a hearing in the subcommittee, they went to full Committee Markup. They skipped three levels of special order, the only reason i think they did a full Committee Markup, myself and others on the democratic side kept screaming about it, mcconnell didnt even do that, he just went right to the floor. This is the problem i think a lot of times republicans get away from regular order, they dont want people to know what theyre doing, the fewer hearings and markups you have on both sides i mean, remember, if you did regular order in the house and senate, that could be 6 or 7 opportunities to look at the bill . Where if you go right to the floor. Theres only one, if that. So i think thats becoming more common. And i think part of the reason republicans do it is because its less opportunity for people to know whats going on. Some people are under the impression that if the Senate Passes this bill, theres a chance the house wont pass it. Can you give people a message about whats going to happen in the house . I think thats wishful thinking. I think its quite clear that the place to stop this bill is in the senate. And i think the reason for that in in my opinion because the senators represent a whole state, what happened in the house is because of redistricting, you just have so Many Republican districts that are so republican that theyre worried more about an attack from the right for not repealing obamacare than they are about the public in general. Senators, because they represent a whole state, will have a significant number of people who are, you know, progressive or progressive leaning, who will be outspoken and say dont do this, because this is really going to hurt people. So i think that a place to stop is the senate, not the house. I totally agree. And were talking broadly about access to prescription drugs and cost. Can you just talk a little bit about trump care and how it affects peoples access to prescription drugs . You talked a little bit about essential Health Benefits and just want to hear more about how bad trump care is. Let me thank you and the senate again for really pointing out the problems with trump care, or with the repeal. I dont like to use trump care. You know why . It implies this say replacement. And i dont think it is a replacement. The reason i say that is because, you know, we paid for the aca with about a trillion dollars in various tax increases, you know, taxes on Drug Companies, on medical Device Companies and some spending cuts. And the republicans repeal most of it, right. The house is like 800 billion, the almost 900 billion. The senate is almost 800 billion. So there is no money left to pay for the subsidies for people to buy insurance or to pay for the medicaid expansion. And so it is not replacement at all. I dont even im not being offensive to you. But trump care implies that trump cares and if he does, you know, maybe he does theoretically, because i dont want to give him bad intentions, but he doesnt understand this is not a real replacement. But what was your question again . How does the repeal affect the essential benefits. Affect access to prescription drugs. The reason i went on to that is because one of the things that got very little attention until the last six months was the essential or guaranteed benefit package. It was always something that i was very proud of, and that i would talk about because i remember in North Carolina, i told the story in North Carolina, before the aca, they were selling insurance policies for 50 a month that didnt include hospitalization. And i would always say that wasnt Health Insurance, right . And thats because North Carolina, unlike my state of new jersey, didnt have to guarantee any benefits, you could sell junk insurance. Now, thats become a focus of a lot of attention now, the New York Times wrote an article about it yesterday. Sunday paper. But for a long time, nobody knew anything about it. And not to take up a lot of time, but ill never forget the day when they were supposed to vote for the repeal in the house on the friday and they didnt. They postponed it, right. That day i remember going to the cloak room and i watched both cnn and msnbc and there was one of the commentators literally had a, like a wall like this, that had the guaranteed essential benefits. And it was the first time that i ever remember any media outlet actually talking about that. Which was so significant. But now it has become a major part of the debate. Of course, you know, if you allow what the senate bill and the house bill what the senate bill did, what the house bill did when it passed, states to wave the essential benefit package, they could theoretically wave prescription drugs or limit it in a significant way. You wouldnt have access to those drugs. Now, of course, as i mentioned before, the latest amendments from mcconnell, based on cruzs amendment, would make it even worse, because it wouldnt be up to the state to wave it if you offered, you know, Blue Cross Blue Shield offered the policy within the exchange that had the guaranteed benefits, the cruz amendment would allow you to sell insurance outside of the exchange and wave the essential benefits package. So you could get somebody not only buying a policy that didnt have hospitalization, but policies that didnt have prescription drugs or even worse, they said were covering prescription drugs but there say limitation on what they offer. And the problem there is people dont know. People buy that North Carolina policy thought they were getting hospitalization and they didnt. Because they didnt know. Yeah, i mean, the only thing i would add is that even putting aside the cruz amendment, and putting aside the essential Health Benefits. Right. When youre when you have tax credits that are intended to buy a plan that only covers 58 of costs, as under the senate bill, then youre going to have thousands of dollars in out of pocket costs, including for prescription drugs. And 6,000 deductibles for people with low income so there are many ways how this is devastating for because people, remember, under the aca, even though some of the plans do have what i would consider high deductibles, there are limits on it. And the house bill eliminates and i think maybe the senate bill does as well, eliminates those restrictions effectively. Yes. So theyre going to get higher and the copays are going to get higher and we dont know whether, you know, the core sharing subsidies even now the president decides on a month to month basis, you know, whether hes going to provide them or not. You know, it is not good. It is not a good situation. Well, just since you mentioned that, talk a little bit about the sabotage that is going on, and, you know, theyre blaming theyre selling this bill by pointing to premium increases and insurer withdrawals as if it is the fault of obamacare. There are two things. First, there is the direct sabotage. And then there is the sabotage because it refused to allow us to move and make any changes that would improve obamacare. Thats ultimately where i hope we go so i can mention that. There are so many forms of sabotage. The two most obvious are my understanding is now that, you know, remember, the aca requires you to have insurance, if you dont then you pay a penalty through your income tax, right . Well, my understanding is that if people didnt check the box on their irs form, as to indicate whether or not they had Health Insurance, if they just ignored it and a lot of people knew that that was the case. Then now the Trump Administration is not enforcing it, so if you just skipped it, and didnt buy Health Insurance, you wont get a penalty. So once you eliminate the mandate, which, of course, both the house and senate bills do, i think the insurance the marketplace collapses. Theyre already trying to sabotage the marketplace by not enforcing the mandate. The other things, the core sharing subsidies. People that get help with tax credits, subsidies, that pay for the premiums, also get help proportionately to their income to pay for their deductibles and copays. Those are the core sharing subsidies. But the republicans took went to court and, you know, so many things that damage they did to the ac with the court action eliminating the requirements for states to expand medicaid which means 5 Million People we thought would have medicaid do not. But one of the other things they did was to get the courts to rule that the to undermine the cost sharing subsidies, and so basically the court said that i dont know if they said it this way, but made it up to the administration to decide when to pay or if to pay them, and trump does it on a month to month basis. He started out in january saying im not sure im going to pay the cost sharing subsidies if the democrats are bad and dont support repeal, then i wont do it. Like a threat, which is incredible to me that the president of the United States would threaten democrats by saying im going to hurt people. But thats essentially what he did. And, you know, i think the day when they have to decide whether to pay is like around now maybe the 20th or 25th, the end of each month, and he waits until the last day to decide whether or not hes going to pay the cost sharing subsidies. So let me give you an example. In new jersey, the Insurance Companies, topher, have to start the process of filing their rate increases or even indicating whether theyre going to sell insurance like in june, right . And then thats finalized and can be changed between june and november. So horizon, which is 70 something in the market in new jersey announced a they filed with a 24 increase, right. And i asked the president , i said, well, why are you raising the why are you filing with a 24 increase . I cant imagine that Health Insurance costs have gone up that much. He said, oh, they havent, congressman. I said, well, then, what is this . He essentially broke it down and said, well, about 8 of what we filed is for increased costs of Health Insurance. About 10 or 11 is because if the repeal goes through, we, you know, there is no mandate, we figure the healthier and wealthier will drop out and it will cost us that much more and i dont remember another 6 or 7 was because trump decides on a month to month basis whether to pay for the cost sharing subsidies, so i dont know whether theyre going to be paid in the next year. So, you know, whatever. All these Different Things add up to 24 increase for what it would be in 8 increase. He says, well, if the repeal doesnt go through, and the republicans drop it, and, you know, you guys then Work Together to improve the Affordable Care act, then by november well get rid of all of these other things and it will be 8 . Right now it is 24 . The sabotage is creating all these problems. So lets talk about drug pricing and drug costs. Yeah. You laid out a number of reforms. And i think there is a tendency on the left or in the Progressive Community to really focus on medicare negotiation as the Silver Bullet. And i think that raises some questions, number one, if youre really serious about doing that, you have to have some sort of enforcement mechanism or it is really just words on paper. I mean, you would be afraid that even if we gave the secretary that authority, a guy like price wouldnt actually do it, is that what you mean . Well, what the what the competeeconomists a experts say, the current secretary we have, but there is also the issue that even if it were mandated. Secretary burwell, that unless she is given the authority to set a formulary, to somehow back up the threat, either by not covering the drugs or some other way, some other mechanism, we at cap, we proposed there be sort of an arbitration as a backup to give the necessary threat to drug manufacturers that if they dont set a reasonable price through a negotiation that then there will be a arbitration that is, you know, conducted through a nonpartisan independent entity that evaluates all of the factors. So there is that issue. That sounds like a good idea to me. I said cap is out front on this. Youre stating that as obviously indicates, you know, how much you thought about it. Yeah, i think that would be a good idea. And then just as another example in the senate, a bunch of senators have introduced legislation that as a backup would link prices to, i think, to the va if the negotiation i think you have to do Something Like that, particularly if you did it. I mean, i guess, look, if this were to happen, and be signed by President Trump, and he obviously supports, you know, negotiated prices, i think price the secretary would go along with it since hes in his cabinet. I would be i think you do need Something Like that would be a good idea. And then the only other issue i want to raise about it is that i think it is not right to think about it as the Silver Bullet and to put so much emphasis on it because medicare negotiation is really just about medicare. And so it is really important to think about this in a holistic manner and to think about how you address these prices as theyre paid for through private insurance, and so thats why i thought it was important that you laid out some reforms like the rems and exclusivity that really get at the problem in the private sector. I agree. And thats why we did mention the other things that we also mentioned the medicaid rebate program. And, you know, i did also mention generics because i do worry that because of the Media Attention to some of these generics that, you know, really have gotten out of line in terms of the pricing, that a lot of the media or even members of congress think that generics no longer play a role in reducing prices. And i think thats not true. So i want to really emphasize that generics can continue to play a role and thats why we addressed generics to some extent in our fda user fee bill and why i mentioned some other things with regard to generics too because i do want generics to continue to play a significant role in reducing prices as well. So i think maybe some people in the audience listening to your remarks and to your proposed reforms might be thinking this all sounds very good, but we have a republican president who although hes talked about prescription drugs a lot, no one can believe a word that comes out of his mouth, there is a Republican Senate and republican house. So what is you know, how do we get this done . What is the strategy here . If were not talking about a legislative strategy in the shortterm, like attaching it to some kind of must pass legislation, is it just about winning elections . No, no. Dont want to give you that impression, but i would like to win and have the majority and well do whatever we can to achieve that. But, look, there were many things not many, a few things that President Trump talked about during his campaign that i think myself and other democrats can agree with. You know, one was high price of prescription drugs. Another was, you know, renewed attention to the negative impacts of trade agreements, not moving on the transpacific agreement, renegotiating some of the others. Major infrastructure initiative, trillion dollar infrastructure initiative. Now, granted, a lot of those havent got much attention and the president hasnt really moved much on them. With the exception of the trade and well see, the jury is still out on that, what hes actually going to do. But i think that there is this negotiation out there, i certainly hear it from my colleagues on the republican side that were not doing anything. And that theyre going to get blamed for not doing anything. One of the reasons i think mcconnell talked about extending didnt talk about it, hes actually announced theyre going to meet in august, the senate, was not just because he wants to repeal the aca but also because they havent done anything. There is no legislationive accomplishments by this congress or this administration. So i think my feeling is that if we continue to push and, you know, the Senate Continues to push and i continue to push that at some point theyre going to wake up and say, well, wait a minute, i made these commitments as president. Ive got to follow through on them. So, you know, with infrastructure, we in our committee put together a lift america act. And this will be the same thing. You said, mr. President , that you want to dress this issue, so lets lay down some markers and lets put together some legislation that will tell you what to do. And push. So, no, i dont think it is just an effort to, you know, bring this up in the context of 2018, though we certainly will to get it done, but to see if we can push them to address some of these things. It was interesting, when Jan Schakowsky did the resolution in the fda bill, i just thought we would have to have a vote and it would be all the republicans vote against it, and all the democrats vote for it. And chairman walden said, oh, no, well accept that. And it was done by voice vote. That, to me, was an indication. They dont want to be on record. They may not want to do much, they dont want to be on record saying theyre not trying to address drug pricing. Last question. Then well turn it to the audience to ask some questions. Lets say the Senate Repeal bill fails. Do you think that there is any chance of a bipartisan stabilization bill or bipartisan fix. I saw that ten of your colleagues came out, maybe last week or the week before, and including mr. Welch, with some suggestions. What do you think the prospects are for that and what do you think should be in it . Well, thats the whole goal. In other words, my goal would be to have them drop the repeal, either because by august they cant get the votes or they actually have a vote and cant move forward. Already they have lost two who say they wont vote to move the bill forward and mccain is out for this week. So the goal would be that, you know, before they leave and in august that they dont pass the repeal and that senator mcconnell says it is over. And President Trump says it is over. And then i think we could quickly move towards some kind of improvement that addresses some of the concerns that those democrats mentioned. I wont necessarily i dont have all the details of what they suggested, but things like mandating the cost sharing subsidies are paid, reinsurance to create more to provide more carriers to create more competition in the marketplace. I would like to see i dont know if theyll ever do this, but i would like to see some way of mandating or creating bigger incentive for states to expand medicaid for those that havent. Those types of things i think would could very that would be the goal and i think it is realistic if they drop the repeal and the sabotage. Were not there yet as you know. I still think it is very likely that they do the repeal. We really got to keep pushing to stop it. Should we open it up . Thank you for coming here today, representative pallone. My name is Steve Knievel from public citizen. A quick comment and then a question. So i appreciated were in alignment with a lot of policies you proposed. And many of them are also included in existing piece of legislation, the improving access to affordable prescription drugs act, 16 or 20 i encourage you to check it out. But relating to exclusivity, specifically, there is also a bill in both chambers of congress that would expand it by six months for when an orphan drug gets a new indication, it gets an additional six months of exclusivie isity on all indicat we think it coulddollars. I would ask you what would you say to any of your colleagues that would be thinking about supporting a measure like that in the well, it is a constant battle as you know on my part and others who are progressive to try to prevent exclusivity from being expanded. There are so many examples. We had the fight with biosimilars, which we kind of lost. We had the fight on orphan drugs. It is constant. Pharma constantly wants more exclusivity. And, you know, all i can say is whether it is that bill or anything else, i generally speaking tried to prevent expansion of exclusivity. Unless there is some tradeoff that is really helpful to the public in terms of pricing or other needs. So i think thats just the constant battle. The companies are going to want more exclusivity. Theyre going to want to fight generics unless they own a generic company, which some of them have purchased. You have to constantly be vigilant. And fight it unless it is absolutely necessary. Im phil pozner. Two things that have been a real problem for accessibility have been with the Insurance Companies, not with pharma themselves. One of them is step therapy. And the other one is the random adjusted fo eed formularies, th therapy is dangerous, particularly with people with Mental Health issues, people with things like ms, you have to try whatever they tell you to try first until it fails. With ms, it takes six or eight months to figure out it failed and then the irreversible damage is done. The random adjustment of the formularies are based upon negotiating between the Insurance Companies and big pharma as to how they get the cheapest price. So you may be denied a drug youve been on for 10 or 15 years as they remove it. I agree. And you certainly addressed, and topher touched on the formulary issue and we can look at that as well. I understand what youre talking about. I dont have the specific suggestions on how to deal with it, but certainly something we should look at in developing the legislation for the fall. Here is, i think, the sort of vicious dynamic that is at work here, which is that Drug Companies skyrocket prices, right. That then creates a pressure on Insurance Companies to throw up barriers such as youre talking about. And then that encourages Drug Companies to jack up prices even more. And it just keeps spiraling out of control. So i think that the really at the end of the day, the solution is going to have to involve in the private sector is going to have to involve a deal between the Insurance Industry and the pharmaceutical industry whereby pharmaceutical industry agrees to price reasonably and in exchange the Insurance Industry agrees to provide reasonable coverage of those drugs and not throwing up barriers. And thats the kind of negotiation that needs to occur. The problem is we have to set up a dynamic where we force that conversation. And there is nothing that is doing that right now. I mean, i think that was going to happen if Hillary Clinton had won because there was the gigantic threat of regulatory action. But now there is obviously not that threat anymore. But thats thats whats going to have to come to pass, i think. One thing, in a general sense, that i have found, which i think everybody rags on Insurance Companies, but, you know, the main thing that i finally want is certainty. Right. Right. And so, you know if you can provide certainty, which obviously this administration isnt doing much related to health care, thats helpful to them. Kind of interesting to me that in this debate over the essential benefits package and the possibility of selling junk insurance, the New York Times article kind of got into it yesterday that the Insurance Companies for the most part have been opposed. Everybody thinks the Insurance Companies want to sell junk insurance. But if you read that article in yesterdays New York Times, you get the impression thats not true at all. They dont even like what cruz is proposing. I think part of the reason for that is they dont like the uncertainty. They want to know what they have to deal with. Which is, you know, one of the reasons why, you know, when i mentioned that example with horizon in new jersey, it is obvious to me that horizon in new jersey would much prefer to not have the repeal go through because then they would not have to speculate about what is going to cost them if there is no mandate and if the cost sharing subsidies are not paid. Yeah. If you havent read that letter, that was released late friday night from ahip and Blue Cross Blue Shield, you should. Because it was extraordinary. Ive i worked in the senate for many years and never seen anything like that letter in terms of how strong it was. And it was i think it is what youre saying they want certainty, they also, i think, want to guard their public reputation. They dont necessarily want to go back to being the evil bad guy, i think, thats partly behind it. But it was quite something. One more question. Lets wrap up with one more question. You pick. Hi. Michael cipriano with the pink sheet. The white house issued a Statement Last week about the house passed user fee bill raising issues with the generic exclusivity provisions. Unclear if it was a veto threat or not, but if the president does veto the user fee bill, are you confident that congress could override a veto if that happens . He doesnt veto anything. He doesnt know what he is signing. I have no doubt hell sign it. He probably wont know whats in it. I think youre right. Im sorry to be so can you talk about the consequences if it were vetoed, if this bill was not if this authority was not reauthorized, what would happen in terms of the nations review of drugs . Topher, im sorry, but i just i have no faith that the president would veto anything to be perfectly honest. Im not suggesting he should. I support the bill, but i just dont see it. The danger right now is that the reason were trying to move this quickly and there has been some suggestion that there are some senators that might put holes on it for totally unrelated, even to health care reasons, you know, how the senate, you know, you dont you dont give me my, you know, destroyer vessel and therefore ill hold up the fda bill. Im not saying thats the case. But i wouldnt be surprised. The biggest problem now is that is with the people that work there. In other words, i think they will actually start sending out pink slips very soon if they havent yet, i guess. They will very soon. A lot of what we do in the fda bill is try to streamline and make sure that the deadlines are good or even better than they are, you know, to get the reason we have the user fees so we get money to the fda so they can hire people and process drugs and medical devices quicker, still being cognizant of safety, of course. You dont want to workforce pink slips because people will leave and nobody will be hired and then the process of review gets slowed down, which is the last thing i want. So thats the main reason i cant imagine that he would, you know i didnt read that as a veto threat. Ill be honest with you. I didnt read it that way. Thank you for coming. Thank you, all, for coming, and thinking just for a moment about something other than repeal. It is good to get my brain thinking about that, other things too. So thank you. Today was President Trumps first Cabinet Meeting with his new chief of staff, general john kelly, who was sworn in during a private ceremony. He replaces former chief of staff reince priebus. General kelly previously served as President Trumps Homeland Security secretary. President trump will be holding a rally on thursday in west virginia. Well have live coverage starting at 7 00 p. M. Eastern and thats over on cspan. And here on cspan3 tonight, it is American History tv in primetime. Well look at whether law can restrain war. And the impact of religion on foreign policy. American history tv, in primetime, starting at 8 00 p. M. Eastern, on cspan3. Tonight, on the communicators well, as the internet grew and there were jobs and people were putting things online and there was money at risk, all of a sudden, hackers started getting jobs doing security. I kept getting these emails of people telling me, give me an announcement to defcon that makes it sound professional. I have to convince my boss to send me to defcon for my job. Finally one of my friends ray kay came up and said, you should throw a real conference, charge real money, and make it a professional conference. I thought that was brilliant. But i didnt have the money at the time. I was too young. I saved my money for a year, took a loan out and started black hat a year later than i wished. Every year, unbelievably, it has grown, for 20 years. Jeff moss, founder and creator of black hat, and defcon talks about his backtoback conferences for security researchers and hackers. Emerging threats to cybersecurity, and how hacking works. Youve got to remember now it is pretty hostile everywhere. It used to be just hostile during defcon and black hat. Now every airport seems to have a fake cell tower operating, fake wifi catchers, because if youre going to steal somebodys logins, why not at the business lounge at an international airport. Thats where the high value targets are. If you monitor your wifi signals, when youre traveling, youll see all these fake stations, amtrak station, d. C. Has a fake cell tower outside of it a couple of times. It is just this is the way that it is. And if youre a criminal, and you can build a backpack to intercept information and just leave the backpack plugged in somewhere, thats so much low risk than trying to rob a bank. Watch the communicators tonight at 8 00 eastern on cspan2. The commissioner of the s. E. C. Michael piwowar has been talking with Business Leaders around the country about regulations and how they affect the economy. The Heritage Foundation discussion ran about an hour. Good afternoon. Welcome to the Heritage Foundation and our louis lairman auditorium. Welcome to those who join us on heritage. Org website. A courtesy check to see if our various mobile

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