tv Key Capitol Hill Hearings CSPAN June 29, 2016 2:00am-4:01am EDT
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>> el they have two questions but first things for coming today and as you have heard many people arel concerned about this ill-conceived experiment additionally the administration has not then responsive to congressional inquiries in addition to a letter signed by every republican on the committee and even some of my own letter and have not received inadequate response asking for clarification whether the proposal constitutes new research i am submitting that letter for the recordop and i hope you wouldn expedite an answer to that. number one. over t among the many concerns over this proposal with the
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results of practices in rural areas like most of my state of iowa are the patients with a rare disease so what safeguards do you have with regard to treating patients served a smaller practices in rural areas with rare diseases? >> i share your commitment to a small and rural practice i grew up in a small town in texas with a 2% family practice we did propose to include rural and small practices but noted we were concerned and focused on the access issues and we sought common tiffany adjustments or exclusions or other changes were needed so we will assess those
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comments to determine if any adjustments are needed. >> number two we have heard from a number of groups that many patients and providers could have been avoided the patients were included in the design at the front end well-planned city put in and rare when faldo small practices of the stakeholders in the future? >> we proposed up process multi phase two that includes input of multiple points including patient input to we're looking at comments now to determine the enhancements.
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this is something we need to be very involved in. another issue raised by the report is really the big issue. it's part b which has been talked about. as you noted in your testimony, in 2015 they 15 they paid $22 billion in part d drugs and according to trustees report nearly 89.5 billion in part d. before talking about the elephant in the room, the area the area we should be most focused is on part b in terms of the cost for seniors. spending increased 8.3 last year and the year before 8.6%. part b, which we are talking about today, 2.4%. when we%. when we are talking about three and a half times more growth, this is the area we need to be focused. dr. conway, if the the goal is
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to drive down prescription drug costs for seniors on medicare program in general, are we focusing on the right part when we say part b or shouldn't we be paying more attention to part d? >> so in terms of part d there are a number of proposals for congress to consider in the part d space. we are open to ideas in part d at all times. we've had manufacturers come to us with ideas around part d and value -based arrangements in part d. similarly we had providers talk about how they want to bring in arrangements that are voluntary between the provider and part d
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plans. we are open to ideas from congress, from you senator, from stakeholders on what we should be doing. >> just to underscore, i've heard from three constituents in the last few months that have had hepatitis c. they weren't sick enough to get their insurance company to get there expensive treatment covered but they had insurance so they weren't qualified for medicare. in one situation they were able to get the medication but in other two instances, that has not happened yet. it's not a good system if someone has to call the senator to intervene to get the medicine
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they need to be able to save their life. this is a huge issue and we will be doing a hearing on part d where the costs are in the areas in which seniors are most concerned. thank you mr. chairman. >> senator robert. >> thank you mr. chairman, i would like to ask unanimous consent that a letter here from over 20 patient groups and many other groups to the finance committee highlighting concerns of opposition be included in the record. >> without adoption. >> when this committee was debating the affordable healthcare act, i was concerned about several positions.
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i believed it would increase independent choice and open the government rationing. there are poor rationing, i'm not sure what to call them, groups and you are one of them. we have before us a proposed demonstration project or test that could disrupt from some of medicare's must vulnerable projects patients. thank you for being here today dr.. i wanted to share with you some comments and questions from a couple constituents in kansas. eileen suffers from anemia and lupus. she asked me if anyone is looking at the possible effect of such a demonstration on the people it will impact. do any of them care the good honest americans will die without access to these
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treatments or are they merely trying to save money by cutting costs. the proposed access will cause a degraded health outlook for many rheumatoid arthritis and other patients it will sign a death warrant for many patients like me. another constituent from wichita wrote about the cms experiment being an intrusion on the relationship our doctors have with patients and their clinical decision-making. this experiment will backfire costing patients and taxpayers even more for cancer care. now, according to the statute, it is to test innovative payment and service of every model to reduce program expenditure while preserving or enhancing the quality of care. that's where i think we are running smack into trouble. how are you going to insure beneficiaries don't have trouble accessing the medications in the setting they prefer like a patient going to a rural oncology doctor in a rural area being sent to the hospital
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hundred miles away. is there anything indicating these changes will improve quality of care or patient outcomes? >> the first goal of the innovation center is to improve quality as you said or maintain quality and this is what i have been doing for 20 plus years, the paramount importance is improving better outcomes. it also is to maintain or reduce expenditures. in this specific proposal we are proposing a value -based framework in phase two which from the private sector to private payers and providers has been demonstrated to focus on
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paying for value and medication. we are proposing to test that in medicare part b and we do believe it can maintain or improve quality and that is our primary focus, on the quality side of the equation. >> on that issue and pardon me for interrupting, i have very limited time, under the aca, the secretary is prohibited from using comparative research findings in determining medicare coverage. however they plan to test drugs based on how effectively it treats different conditions. do they believe that as the authority to waive this prohibition, are you doing what you should be doing? >> so in terms of the innovation center, we are proposing to pay for value which can be things like sharing arrangements based on outcome so it is consistent with the statutory authority to test new payment and delivery models.
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i'll highlight on them broadly, we have thousands of providers in every state in the nation engaged in the delivery system reform. we have millions of patients that received, in many instances, demonstration and improved outcome and improve care experience and we can certainly talk about that more. >> thank you doctor. i appreciate that. you have said that the public comment concluded on may 9, they are considering all the comments on this proposal it receives throughout the comment time. i think that was mainly about medicare pricing fax and that is in direct conflict with the letter that we have here from 32 patient groups that say there was a lack of stakeholders input in the beginning of this process and many of the problems could've been mitigated had groups been involved on the front-end. i think what we have here is a failure to communicate.
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i remain gravely concerned about how this demonstration are test will impact patient access to care. i would like to reaffirm my request that cms simply withdraw this proposal. >> thank you, mr. chairman. >> senator menendez is not here. senator portman, your next. >> mr. chairman, thank you very much. i appreciate you being here doctor conway and for your service. as you know, my wife is very involved in incoming chair of one of our great hospitals. i wish i could say the same thing about this proposal about the hospital, i am am concerned about it. i'm concerned about it for reasons that have been stated
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already. i want to ask you about one pacific specific deep concern. it's called a demonstration but my understanding will cover about 75% of part b medications which is hardly an experiment. the control group is 25%. i was just looking through some of the information i've gotten in letters and e-mails from some of my constituents, tom clark, his wife is a cancer cancer patient and he's worried about her ability to get her cancer treatment. barbara writes a long letter about her deficiency disease and what's going to happen to her. she is applying for disability now and is having a tough time but she faded and at home and she has to go to the doctor. if she goes to the hospital will be much more expensive and/or they won't be able to afford to provide it. just a lot of deep concerns about it.
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the specific concern that i'm hearing from ohio is more about these community health centers and rural health centers. we lost about 50 practices going to the big hospitals, this will continue that and accelerate it, i think this proposal which is again not a demonstration hardly, if it 75% coverage, but it's a whole scale change is going to really dislocate a lot of people i represent and cause a huge concern among some of these smaller practices that are already having a tough time making it in the current healthcare environment. let me ask you about something that concerns me about your specific proposal that perhaps you are not aware of. i assume if you were aware you wouldn't be doing it. this is a neutral proposal and so you cut reimbursement for some of these outpatient clinics that were talking about and some
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of these providers who will have a tough time making it and you increase reimbursement and other areas in order to make it revenue neutral. one of the places you've increased reimbursement is with regard to prescription drugs that are used for pain management. specifically, you have a dramatic increase in reimbursement incentives for the kinds of pain medication that is addictive and causing much of the problem we have now with this opioid epidemic that we have now in ohio and around the country. let me give you some numbers on that just in case you're not aware but on the expected impact on pain management medication, you are seeing an increase of 46.9% versus a cut on oncology drugs by minus .6%. it's your dramatic increase and
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i think the whole basis of your proposal is that if the reimbursement reimbursement is cut, on the other hand you are increasing reimbursement at a time when i think there's a general sense in the administration that there is too much overprescribing of certain kinds of pain medication. it's addictive and causing so much of the opioid crisis. the addiction recovery act deals with overprescribing issue and drug monitoring. i think there is a general view that this is a problem and we work closely with them. we are the co-authors of that legislation. this seems to run counter to that. all the concerns we hear from other colleagues about these providers is a concern of mine and the fact that there's now a demonstration. i have this bigger concern that
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under this proposed rule, which you say is to prescribe the most effective drugs, the reimbursement for this particular kind of opioid, this increase could have a very negative impact and increase the problem with the opioid problem. it is believed that four of five heroin addicts that are overdosing today, 129 will lose their lives on average today, four of five of them started with prescription drug and often it was for pain medication. it was a a prescription they got because of her procedure. could you briefly respond to that? >> so three quick responses. one on the scope, we are evaluating the comments and will determine whether adjustments are needed. two, on on the practice issue, overall it is budget neutral as you describe. there is a slight impact toward
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the clinician space. the focus on the opioid use, for the first time we have zip codes in the u.s. for life expectancies going down and a lot of it is due to the opioid epidemic. what you have named as the fixed fee. there is some very low cost as you where the percentage increase looked large. we'll have to look at that specifically and determine across classes of drugs if any changes are needed in the proposal. >> just one comment, if i could have an answer to this in writing, fenton all is an example, it's a big problem right now around the country. it's believed it's causing more overdoses in ohio then heroin.
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it's with the synthetic form of hair went. as i look at this it receives a 2000% increase in reimbursement under this model, fenton all alone. i'm very concerned that we are incentivize increase utilization rather than the opposite. >> that is from the fixed fee but we can give you a formal answer. that's from the $16.60. >> thank you, mr. chairman and thank you dr. conway for being here. as many of my colleagues have already pointed out, the lack of consultation with stakeholders is striking and a further indication of the nature of this demonstration but i of the entity. i want to draw attention to one section of the authorizing statute that states that cmi should consult representatives and federal agencies. we know at the federal level there is a national advisory and
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the newly created council all related to policy. i'm also told they coordinate to ensure that healthcare providers in rural america can function to the best of their ability within the boundaries of our statutory and regulatory frameworks. the question i have is, can you inform as to whether see mmi, as it is required to do, consult with these various entities dedicated to rule health policy to ensure that what many of us is a flawed demonstration program would not add adverse impact. >> see mmi works closely across the federal government. this proposal went through the standard clearance interaction processes and you mentioned the task force that we establish.
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we think that's critical for rule issues and as i noted earlier, we made a proposal in rule areas but we also noted that we were focused on access in rural areas and access to medication so we are going to review the public comments now and determine whether any adjustments are needed in rule areas. could you detail the feedback that you received from these entities that i mentioned after this hearing or provide any documents you might have? >> yes, we can provide him put on the process. yes, it would be nice to know if in fact those entities were consulted and what their feedback consisted of. >> i understand. it's well-known that not all drugs utilized for the treatment
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have cheaper alternatives. the question is, how will beneficiaries who need these life-saving treatments have better access to care when their best treatment option may force their provider into a situation where he or she no longer afford to provide it. >> so, we would want, and i would want every doctor including any cancer doctor to prescribe the medicine that their patient needs. we believe this proposal maintains access through the average sales price plus the two and a half add on fee plus a fixed fee. however, these are the type of comments that we would look closely at. if a physician or clinician could show that this is an access concern both in the comment. where we consider whether adjustments are needed, we would consider that, we also pursue proposed and exceptions process where we proposed practices or
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patients, if the proposal created an access issue, we could make adjustments. just to give you a long answer on this one, i was asked earlier, do i personally get e-mails all the time for medicare beneficiaries that can't access the medication. as a practicing position i care about that deeply and i want patients to have accents to the right medicine. i want every patient to get access to the medicine they need and i want every doctor to be able to prescribe the medicine they need to their patients. those are the types of comments that we look at very closely. >> i will just add, if you have a provider that is no longer able to afford the drug and you have a senior who must afford treatment at a hospital's outpatient department as a consequence, then how is that going to increase cost sharing going to impact their ability to receive treatment? >> so i think first, we will
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review the comments that came in, but also, if using about a practice, i hope the people are in the practice looking at it across the board as opposed to one individual drug. of reimbursement goes up for oncology products in terms of the formula that was proposed, that's obviously revenue to practice. we are going to look at overall access to medication in the aggregate for the policy and whether adjustments are needed and also in the specifics, a medpac puts out information on this and what different ideas they had and access numbers that they think are covered by different asp plus two and a half or three and a half patients. we will look at information from the public comments, most importantly and in the public domain. >> my time has fired thank you for joining us today. thanks for your hard work.
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you have a tough job. we acknowledge that and admire the energy that you bring to a very tough challenge. i've heard about the demonstration and the question is why is it so big. most the time demonstrations we work with, we tried out before we do it in the entire country, but why such a large expansive demonstration? >> so first, it is a proposal so we will seek comments on the scope and many people have noted that. what we think about in terms of proposals is first and primarily the statutory mission which is proposed models we think have a high likelihood of improving quality and lowering cost. then on the g of traffic scope we needed think about three issues primarily. one that areas are big enough that most practices will be within an area, sort of the
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geographic size and two that it's evaluate a bowl. the goal is to evaluate models and determine whether they meet criteria in improving quality and lowering cost. you have to have a large sample so you can evaluate the model. three, you need to have comparison groups. geography allows you to compare to other comparable geographies but we will look at the comments and determine whether adjustments are needed i just want to read you a short paragraph of a memo that my staff gave me. cms expects this phase one demonstration project to incentivize incentivize physicians and providers to. certain doctors who often
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prescribe higher cost drugs will receive lower payments while primary care positions will likely receive higher payments. is that a correct assessment? would you just talk about that. is it correct, do you want to modify it? >> that is from the impact table so it is correct, there are relatively, modest adjustments for oncology and rheumatology. there's also adjustments in the primary care arenas. we publish an impact table because we want to be transparent about the current proposals affects and if adjustments are made, we would publish a final impact table with the effects across practice types. these are the types of issues we care deeply about and want to be transparent. >> thank you.
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>> last year medicare part b spent about $22 billion on prescription drugs. does that sound right. >> yes. >> several drug companies have proposed value -based payment models to ensure patients and medicare are getting the best value outcomes in return for a fair reimbursement. my question is as the proposed part b demonstration project, has it helped cms to effectively evaluate value -based payment models for prescription drugs and the second half of that is, is the stage of demonstration necessary for advancing these for prescription drugs? >> yes, so we propose the two days approach. they are proposed as separate arms, if you will of intervention and yes, the second phase directly builds on what we've seen in the private sector
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about the desire to test value -based arrangements such as outcomes -based pricing and other methodologies that incentivize higher value and outcomes, hence our proposal. >> you asked a lot of questions here today. did you have a question that you wished had been asked that has not been asked? >> my staff will probably give a better answer later and then i'll feel bad. i think one, we haven't noted the innovation specifically that congress wrote in the statute, and i will not get this language exactly right, we cannot limit any benefit to medicare beneficiaries and we are not
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limiting benefits to medicare beneficiaries. i said this but to reiterate it, we care deeply about access to medications, innovation and better health outcome. the question we collectively have to work on is how do we achieve those outcomes. the current system today, i literally get contacted daily from beneficiaries that don't have access to a given medication or don't have access to care in a given area. if we think this data's quote was optimal, we are mistaken. i think we are learning path today that is much better than it was three years ago. >> thank you for joining us. just a couple questions. we are running well into the votes all go quickly.
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i want to go back to the scope issue because it is something that is a concern raised by many in my constituents and by my reading of the statute. it's the affordable care act that states they have the authority to test the model addressing a defined population for which there are deficits and care". this rule would change the terms of reimbursement for 75% of all docs who administer part b drugs under the asp approach. every single drug that is subject to the asp six reimbursement, as i understand it. how could that be consistent with the congressional intent of a defined population? it just seems almost universal, which is not the same. how is it a defined population?
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>> so, as you noted, they are testing a new delivery model. here we defined a population based on geography. we are looking at the comments now and the scope of that geography. >> just so i understand, it's true as i understand it that they will undergo different experiments, but almost everybody is involved in this experiment to some degree. so the current proposal has three arms and therefore does have, as you noted 75% approximately of the country in false. we will evaluate comments and determine key issues around the number of arms in the study and the geographic scope and whether adjustments are needed.
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i would just wrongly issued encourage you to focus on the issue. i wasn't here when the affordable care act was issued but i think a layman's reading of the population suggest something much narrower than what's defined here. something that goes to the purpose, as far as i understand the stated purpose is to make sure there's no incentive to drive positions towards a more expensive alternative than some other alternative which the current system seems to suggest. in the june report they listed ten drugs with the highest part b expenditures. you know how many of them of generic alternatives? >> i don't want to quote a number because i'm not sure. >> the answer is zero among tent the top ten. clearly it's not the payment model that drives the dock to
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prescribe the ten highest expenditure drugs, it's the the fact that there's an alternative if we were to make this change, i don't know, is there concern that it could create an incentive for physicians to experience with off label use for some purposes? was that a consideration? >> so if you comments. one the proposal does not just focus on drugs where there are interchangeable's, if you will, so for example, in her teen changeable to generic. we think the average prices the average cost of the drug +2 and half percent, plus a fixed fee a fixed fee. we will look at the public comments to determine if there are adjustments that are needed in that formula, either overall overall or in certain settings.
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so the goal is for both high-cost drugs and low-cost drugs that we are paying appropriately for those drugs. the current system does have a disincentive that we have heard from mid back and others on the low-cost drug where if it's a $10 drug and its $.60, 60 cents, the real question is whether that covers the cost of the physician or clinician prescribing said medication. we are trying to remove the financial incentive but still pay appropriately for the provision of drugs that you named or other drugs, once again we would want the oncologist or other rheumatologist physician or clinician to prescribed a medicine that they need us to pay and the physician for the patient to receive the medicine they need. >> thanks. >> i think my colleague, dr. doctor conway we are at the point in the hearing where the choices either for me to filibuster into my colleagues get back or to offer a couple suggestions.
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i will route and ask you about how this interacts with other reform proposals. it's obvious there has been progress made to moving the health care system one that moves away from volume. you all reached the target of making 30% of medicare medicare payments through alternative payment models. that's a plus, nine months earlier than expected and obviously what's called the legislation, the medicare access bill that has this critical program for kids has to last year to reap laces hugely flawed program with the payment system i have heard from some providers
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that the proposed part b drug demonstration could unintentionally discourage participation in the new payment delivery and reform models such as the oncology care model in the alternative payment models incentivized by the major medicare legislation. what would be your response to those concerns and how do you envision making sure that this demonstration doesn't in any way discourage participation? >> thank you. we think this program aligns with those specific programs. to give you an example, the the construct of that program was to pay for value.
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we think they would actually work well together. we do think through different methods of evaluating where one model in another area and estimate and encourage participation in the new payment model spirit i will not filibuster but i will, your leadership in this committees leadership on delivery system reform has been hugely important. the care choice model rise with the hospice care community.
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>> it would be helpful -- >> i want to thank you for that. >> i think will be helpful if you could explain something resembling english, exactly how how medicare choices worked because this was something that i had really been dreaming would be done almost since the great panther days. as i understand it, what you all are doing with medicare choices is trying to make sure that eventually, because this is a big pilot, eventually every senior in america could have the opportunity to get hospice without giving up the prospect of care. your physician and i gathered that this also would make it easier for patients and families to time the kinds of choices that they make so that it's best
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for them. could you explain how that works. >> you are correct. we are pilot testing the ability for patients and families to choose concurrent hospice and pallet care. it's actually in almost 40 states and it allows for much more patient centered choices. i'll actually, if it's okay, in that panel that handle i had the pleasure of sitting between, it was one of the biggest positive changes in hospice care in u.s. history. we will continue to modify and learn and refine based on input from congress and others but a huge positive step as a son and physician, i have have been through that with family members and patients and it enables much more patient centered choice and probably the most powerful was i
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sat on the other side, a gentleman whose wife passed away and said if this had been available for her they would have been able to make better choices that would have more aligned with their goals of care. at the end of the day, that's what it's about. it's about patients and families as you know and have been a leader in making choices for them. >> keep me apprised on the sprint i want to recognize senator cardin. i just want to understand that that program, that program to provide more choices for older people, that was really born in this room because during the affordable care act, my colleagues remember this discussion, we have constantly heard this nonsense about how there were death panels. there were no death panels. now with medicare choices, it's very clear that older people are going to have a wide array of choices that allow them to choose what's best for them and
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aligning with their views about health and religion and morals and all of the other factors. i appreciate your take. >> thank you senator, i really want to drill down a little bit as to what your objectives are, particularly as you move toward the second phase of the demonstration. as i understand the first phase, and i was listening to senator portman's questioning, its revolution oh which means you'll have winners and losers and i understand what you're trying to achieve in trying to do it in a way that uses current resources more effectively in dealing with the reasonable costs associated with administering these drugs. the second phase i'm not quite as clear as to your objectives. that is, is it your anticipation that it will save projected costs and if it's going to save projected cost, do you you know
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the range you are trying to get to in that second phase? >> yes, we believe both phases have the potential to maintain or generate savings and improve quality for patients and the second phase, as we put in the proposal, we would come forward in the future with the specifics around drug classes in the very various tools so outcome based prices and risk sharing arrangements and indications, we would come forward with the classes and specific proposals and we would get patient input and consumer input and input from others on those proposals. to give you a tangible example that's come to us from outside these entities that want to do risk sharing arrangements where if a given drug may lower cost
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in the part a and b space we think about how that could have benefits across the healthcare sector. improved quality and lower cost. we have lower cost sharing for beneficiaries. they are selecting certain medications as one of the proposed tools. the goal here is to test an array of tools that have been used in the private sector to improve quality and lower cost to test them in the medicare part b program. >> we have seen in previous efforts imposed delivery system programs that are more cost-effective and better value that the budget can prevent if it was implemented the way it was intended because you need to produce a certain amount of cost savings since everyone has to share in the reality of the budget. do build into this demonstration the confidence and credibility that you really are looking for
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value and not just a cut of cost issues? >> so our statutory authority calls equality expenditures expenditures but we focus on patient outcomes first. when we think about new payment model test, we lead with patient outcome. i think we take that approach here as well. our goal is to maintain access to improve outcomes for patients and then to either maintain or lessen expenditures. the statue includes the ability of the program improved quality and maintains expenditures but that can meet criteria for expansion. >> how do you intend to engage the stakeholders as you go through into the two phases here? >> we are reviewing the comments now but i'd say the principal that we will try to put in place
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which is true across the innovation center is robust patient and consumer input into the model, input for provider across the health system and at the end of the day, we know that broad input and transparent processes are critical to shaping this work. i mention this earlier but we now have them in all 50 states, thousands of providers and millions with deep engagement with the various participants. our bundle payment model, 48 states, over 15 over 15 hospitals and physician groups and others redesigning care for others and improving care and care coordination. that's the kind of engagement we want. >> does my colleague have any additional comment.
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>> i have a lot of comments but related to the subject, marilyn is in a unique position in one of the issues that we will need to talk about is the impact it has on each state including my own state but it's different for maryland. i assure you, my principal objective is that it's getting better value and better outcome. i think the more you can coordinate, the better off you are. i always am concerned that the pressures on the budget are used at times to use well intended programs but just to produce savings rather than better outcome. i take you for your word when you said that's not the objective here and we obviously will be watching this pretty closely. >> let me think my collie, just one last question from me, the demonstration seeks to move into this value -based arena with
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steve heard that i and others is something that's had support on both sides of the aisle and we believe it is constructive moving away from clunky value driven fees, how does it coordinate with the other laudable goal of precision medicine, and all you all seek in the days ahead to really make sure that drugs and treatments and what strikes me about this as it means what it sounds like, it's really tailored exactly to the needs of the individual recognizing this one particular drug or therapy doesn't affect george and harry in the same way and it certainly doesn't affect george and sally in the same way. tell us if we would so we have a sense of where you're going, how
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does phase two in particular builds on the precision medicine initiative? >> thank you for the question. we think it very much aligns with precision medicine and supports precision medicine. let me explain how. for example, if you had a new therapy that generated significantly better outcomes for patient and you're paying for outcomes and value, that actually supports paying for that therapy and the innovation it delivers. similarly, indications pricing, you can imagine if you can really tease apart, for which patient does this therapy effective and pay appropriately for that, it really incentivizes precision medicine, better outcome for the specific patients and we think a very
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exciting place to work across the healthcare system, manufactures payers, providers, patient groups and paying for value and better patient outcome dr. connolly i have great admiration for the role that you play and it's got to be extremely tough for doctors. to defend an agency who says we can determine treatment better than the attending physician, because i think that is what this does, you stated that you met regularly with patient and provider groups. have any of those groups that you've met with been supportive of this rule? >> so we continually meet with
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patient groups, consumer groups, provider groups. >> the questions very simple. have any of them been supportive of the role? >> yes. >> would you would you provide for this committee the list of those groups who have come in and said we are supportive of this part b roll. >> yes i believe we may have even received another letter recently but we can provide that information. >> is cms considering withdrawing this role? speak yes or no. >> we are evaluating the comments now and intend to take those comments into account when finalizing the rule. >> are they considering withdrawing the rule? >> we attend to take the public comments into account. >> are you doing this to save money or to reach a better health outcome? >> we are doing it because we believe it can reach a better health outcome and maintain or lessen expenditures. >> does cms believe they can
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design a better treatment pathway than it physician can? >> as you noted i'm a practicing physician. i believe physicians care about their patients and i want physicians and clinicians to make treatment decisions based on what's right for their patients. i would like, and the agency is focused on maintaining that a patient, a beneficiary should receive the medicine they need and they should prescribe in all instances the medicine that is best for their patient would you also agree that the location they get that is important. >> transportation is the number one issue in this country. it is in the veterans administration and medicaid. i believe it is in medicare.
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when you limit the rule access to these life-saving treatments, had you in fact bettered the outcome? >> we do not want to limit access including in rural areas, many of my family members are private practice physicians in independent practice. we support independent clinician practice. we are proposing a model that we think can support role and small practices but we will review the comment. >> what about disincentives that exist in the current system. you don't consider the disincentive for a local -based delivery.when you are saying, if you go to the hospital we are going to pay you more money. >> this proposal proposed to pay
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the same p +2 and half percent plus a fixed fee both in the hospital out outpatient. >> our objective was to bring forth promising breakthrough therapies as fast as possible including those that would be impacted by what cms is proposing. they sought remarkable success in bringing forward cancer patients even faster. as a result of the law, 130 drugs have been designated as breakthrough and more than 45 drugs have been approved by fda so far. i fear this demonstration project will jeopardize access to these breakthrough drugs just as they are becoming available. can you assure the committee today that your proposal will not negatively impact the
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success of the breakthrough therapy? we believe the proposal aligns with innovative breakthrough therapies because the proposal is about focusing on paying for drugs and therapies that generate better outcomes for patients. we have also written expressed concerns about this proposal. physicians and caregivers are not prescribing medications to profit themselves. they are prescribing medications because they work. do you fear that providers are profiting themselves versus providing the therapies because they work? >> i would want those physicians to continue to provide the
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therapies that work for their patients. >> if they feel like this, in some way shape or form takes their ability away from them, then you would see a need to change this legislation. >> we want to review bears than any other comments because we want the proposal to support access to medication for beneficiary. >> last thing mr. chairman. >> the time has expired. a north carolina in is suffering from immune deficiency and he writes members of my community on medicare and the providers who care for them already face complexities assessing accessing medical care and treatments. they should not have to face the consequences of an initiative that eliminates their treatment options. this cost-cutting measure would become a life cutting measure. i urge you to intervene to stop this proposal. >> that's a patient. i think they have probably heard from a provider that if this
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goes through, here's the impact on you. what do you say as a dock? >> i would say i want them to receive the medicine they need for their immune deficiency. i would say to their physician, i want them to prescribe the right medicine for their patient at all times like all physicians should. >> i urge you to look at this proposed rule. >> senator scott. >> thank you for being here for today. certainly you're from a rule part of texas and i'm from a roll stay in south carolina. i think we both have affinity for the costs living in all areas that are absolutely severe. the thing that i have heard from my constituents consistently as it relates to this demonstration project is fear. they are scared. i know your mother is on
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medicare, senior citizens living in rural south carolina are scared. they are on fixed incomes and we now have a demonstration project that covers the entire nation. what they see as the results of this experiment will be higher prices. less access and perhaps, in order to receive the life-saving treatment that they need desperately to stay alive and see their grandkids one more time is a two or three hour drive from south carolina to charleston.
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is the value of proposition of their visit to the doctor and i think we can agree these concerns are valid considering the scope of the magnitude and the impact on citizens and i believe you have desires and intentions that are good looking for ways to help medicare battle before your mother who is currently receiving the benefits, but for your for kids, i think we share the same concern perhaps with the different outcome. i hope and i would even plead with you on behalf of the citizens of south carolina better so concerned about this project with a step back from the nationwide the plantation
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and though certain paychecks are benefits. so to highlight a couple of various into rare disease arena sickle cell is a very powerful weapon against a nominee in my state. those who need blood transfusions are one of the only the kids. it is clear they are excluded from phase one but it is unclear if they are excluded from phase to. can you clarify? >> you are right on blood products being excluded from phase number one. if we would never to put out a proposal with phase number
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two to come forward for those areas that we plan to address with both public and put impatient consumer input so our goal is to engage and with patients and consumers and as noted in a proposed rule if there are classic is or other issues to be addressed then we would look to the public comments to consider how best to address these issues. >> everybody else has gotten an extra one so feel free. >> i appreciate the extra 10 minutes. [laughter] i didn't think that was that funny. but i appreciate the fact that concern for my constituents and now to turn they can spend on the road
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if you are living it just isn't day hoppes get a jump. it is a more serious proposition obamacare can provide up partnership or ride sharing service how can we justify them to transport young adults with a program you are proposing will limit access for the most pleasurable have we figured out the transportation sharing program to help with the impact in rural areas? >> for the proposal we would want to maintain access
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including those smaller practices. for patients and physicians who once deliver medicine we want them to receive the medicines when and where and how they want to. we thought the proposal maintained access with improved quality. and we're looking closely at public comments including smaller practice issues. >> / will stop for i started. >> at no doubt the sincerity or the intentions over anyone. i do want to echo my concerns for those particularly in the rural areas. and sickle cell is among them.
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and to be financially strapped but that means you have too much month for the money they have for those that are seriously challenged and as you have heard echoed throughout the hearing today the concerns are real because the intentions are good but the access issue has a real concern so you may have less static number with the impact of those numbers can be quite high. >> thanks senator scott. you are a pediatrician, a career employee in this deport - - department and
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the republican leader. mr. mcconnell: here's where we are, mr. president. we have a public health crisis descending on our country. we've been talking about this for three months. the administration, the c.d.c. r-- all involved said we need to get this zika funding bill done before the 4th of july. before the 4th of july. this conference report, which was just prevented from passage, has exactly the same funding level that every single democrat voted for when it left the senate -- exactly the same funding level. we know that if we don't get this job done, we won't have a vaccine within a year and a
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half, and in the short term, we've been told that the single most effective thing we can do is kill as many mosquitoes as possible as fast as possible right here in the united states in the southern part of our country. and so here we are in an utterly absurd position, playing political games, as this public health crisis mounts here in our country. pregnant women all across america are looking at this with dismay, utter dismay. as we sit here in a partisan gridlock manufactured by the other side over issues that it's pretty hard for the general public to understand, refusing to pass the funds needed to
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address this public health concern. if that were not bad enough, we've also stopped the passage of the milcon veterans administration appropriations conference report -- funding for our veterans, funding for construction at military bases. so here we are going into the 4th of july, we've impeded the passage of funding to deal with an impending public health crisis, and in the same vote managed to vote against veterans as well. so i say to my colleagues on the other side, that's where we'll be when we come back here after this brief break for the 4th of july. i've moved to reconsider -- i changed my vote and moved to reconsider, and you'd like -- and i'd like to call on my colleagues on the other side of the aisle to think about this,
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to think about where they have left this issue for the american people. i've been approached in my state, and you know others have as well, from young women concerned about whether we're going to address this issue now -- not sometime in the future. and so when we get back after we've had time to think about it all, we'll address this matter again and hopefully respond, as our constituents all across america are asking us to respond, to this pending health care crisis. -- that we all understand. there's been plenty of discussion about this for months. this republican majority has met the deadline, but we can't pass
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it by ourselves in the senate. i hope that our democratic friends upon reflection over the course of the few days we'll be away to come back with a different attitude and i hope that we can address this crisis and address it now. mr. reid: mr. president? the presiding officer: the democratic leader. mr. reid: as i said this morning, and i will repeat it, i don't know what universe my friend is living in. what does he think we'r -- whate think: we're all stupid, the american people are dumb? they're not. they understand what's going on here. we have been trying for months -- months. the president asked more than four months ago that we would get money to fight zika. he had already had to take $500 million from ebola because the republicans had done nothing,
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and he said more than four months ago, we need money. the c.d.c. needs money, n.i.h. needs money. we have a crisis on our hand. so we've been on top of this. we've worked hard. the republicans have objected five times to moving legislation that's meaningful. april 28, the senior senator from texas objected to my request. may 18, he objected to my consent again and to murray's request, all in the same day. on may 24, he objected to senator murray's request again to funding zika. and on may 24, same day, enzi objected to senator nelson's u.c. request, unanimous consent request. he said, we need to reflect. come on, mr. president, listen to this. listen to this.
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if republicans were sitting around, as i assume they were, in the house, as we were all watching the takeover of the senate floor by house democrats -- there wasn't anything going on the house floor. so i assume -- i assume -- they were sitting around. what can we do to fake a u.c. -- to fake that we're 23u7bdz -- to fake that we're funding zika? what can we do? well, maybe what we can do is say that we have money for zika and then we can do everything that we can to irritate them. so what they did is they said, -- they realized that this was a serious issue. but, you know, these pregnant women are the ones they're concerned about. so why don't we stop them from going to have birth control? why don't we -- again, we hate planned parenthood. so we'll just stop them from going to planned parenthood. these desperate women who need
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birth control, they need some advice about their situation, a significant amount of american withers especially young women, go -- a significant a american women, especially young women, go to planned parenthood. on the bill that was just turned down today, the republicans said you can't do that. we're not going to allow that. it reinstructs funding for birth control at planned parenthood. how about that one? but if are that weren't enough, they cut veterans' funding by $5 million. and then i guess -- well maybe we can do something we know we hate the environment. we don't like all those people -- these greenies. so why don't we do this: we know that it's important that we control mosquitoes. if we're going to do anything regarding the mosquitoes, let's kill a lot of those mosquitoes. well, here's what we'll do: we'll exempt the clean water act from the provisions of spraying
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pesticides against every environmental advice that we could get. they go ahead and do it anyway. they cut ebola funding by another $107 million. they rescind obamacare by $543 million. after they've already failed seven times to -- 70 times to repeal it. but, mr. president, if that weren't enough, here is -- listen to this one. how about this one: i guess they say, what else could we do to realistic it in their eye? now, there is a prohibition now in the law that says that you can't fly the confederate flag on our military cemeteries. let's take that away. we want to be able to fly confederate flags on military cemeteries. so they put that in there, too. what do they think this is? when we passed here by almost 90 votes a bill that gave -- not as much money as we wanted but $1.1 billion. it was treated as an emergency,
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as an emergency should be treated. no different than a flood or a fire. -- an earthquake. we passed it here. we sent it to the house. the night they were there on the house floor, there was chaos. one of the presiding officers came out and in a matter of a minute said we're going to pass the conference report funding zika, funding zika. but it makes it so that you can't go to planned parenthood for birth control, taken $500 million from veterans, we're going to affect how you spray pesticides, we're going to cut ebola funding, we're going to cut obamacare, and we're going to just for good measure, i think what we will do -- just for good measure -- we'll throw in the confederate flag thing. mr. president, i was here a week ago. 2,200 women at that time were infected with zika. here it is one week later and it
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is $2,900. about -- and it is 2,900. about 100 women a day are being infected with zika. there's been 500 of them now that are pregnant, that have been infected with zika. we don't know how many of those women are going to give birth to these children that are tremendously handicapped. shrunken brains, their skulls caved in sometimes. as we sit here dithering because of this foolishness on planned parenthood, clean water act, obamacare, ebola funding, confederate flag, each day more women are prevented from getting the attention they need for birth control. it is unbelievable that someone would have the audacity to come to the floor and say, well, it's the democrats' fault. the democrats' fault. we think you should get some money for zika funding. it should be offset -- it
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wouldn't be truly an emergency funding. in the process, go ahead, and let's whack obamacare, ebola money, veterans, planned parenthood, confederate flag -- i mean, i can't imagine -- i can't imagine how anyone would have the audacity to come to the floor and talk about what a great piece of legislation this is. we know what's in the bill. we know what's in the bill. we've had a woman that has worked so hard on this, who's one of the premier senators ever to serve in this body, mikulski from florida -- i mean, mikulski from maryland. of course, bill nelson cares about this. i got "florida" because his state is being hit more than any other staivment but senator mikulski has worked hard on appropriations bills. we know how much she wanted it passed. but she doesn't want it with this awful stuff that they've
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tried to do with planned parenthood, the clean water act, veterans funding, all of this other craziness, including the confederate flag. it is hard to describe. i said here this morning when the senate was opened, i've been here a long time. i don't ever remember anything as outrageous, as shameful as this piece of legislation. and, believe me, in the last seven and a half years, the republicans have come up with a lot. but this is the worst. the presiding officer: the republican whip. mr. cornyn: mr. president, i'll tell you what shameful is. that's allowing more women of child-bearing age to contract the zika virus so their babies can end up looking like this. t.
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that's shameful. make no mistake about it. our colleagues across the aisle have filibustered on a partisan basis a bipartisan bill that funded our anti-zika efforts. and also included measures to support our veterans. so we need to be absolutely clear. i heard the democratic leader basically saying that because his party is a sore loser in a conference report that they don't love, that they're going to block funding to prevent more babies from contracting the birth defect that is suffered by this baby. microcephaly basically is a shrunken skull. this baby's prognosis is not good. women of child-bearing age are
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scared to death that their baby will end up like this baby. yet, their concerns have fallen on deaf ears among those in this chamber, largely democrats who voted against advancing this legislation. we're getting closer to mosquito season. the warmer weather means that we're going to see more mosquitoes, and we need to get this on the president's desk as soon as possible. the president's h-pl asked for $1.9 billion in funding, calling this a public health emergency. but our democratic friends block it because they're sore losers in a conference negotiation report that they don't like. we know that this virus can affect an entire generation. this birth defect is heartbreaking and life-altering.
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and we know it's taken a tremendous toll in much of latin america. fortunately so far the only cases of the zika virus in the united states, according to the center for disease control, are those contracted from people who traveled to south america and central america and contracted the virus there and come home. so far the mosquitoes that carry this disease are not spreading it in the united states, but we know that that will change soon. that's why we heard the senator from florida, the senators from texas and others talk about its potential impact in the united states, and particularly in our warmer states. according to the center for disease control and prevention, severe miccephaly, like this is associated with seizures, intellectual disability, hearing and vision problems and
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developmental delays, and that's assuming this child survives into adulthood which most, unfortunately, do not. so how are friends across the aisle who voted against this conference report which provides zika funding could look the mother of this baby in the eye and say we had plenty of good reasons to deny help for more children like yours, we know this impacts not only children and these babies, it also impacts whole families. it means mothers and fathers anxious about the welfare of their baby regularly going to the doctor to gauge progress and check development, and it means finding speech, occupational, physical therapists to help the child live as normal a life as they possibly can. one neurologist quoted in "the
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new york times" says there is no way to fix the problem, just therapies to deal with the downstream consequences. so once a baby like this contracts the zika virus, there is no way to fix the problem. the only defense is to prevent children like this from getting the zika virus by getting the fund that democrats just voted down to the medical authorities so they can look for a vaccine, so we can do mosquito eradication and the other things we know we need to do from a public health perspective to prevent more pwaeubts like this one -- more babies like this one from developing these devastating birth defects. as i said, there's no cure. once a baby has it, she or he has it for life. and that means that the family will have to live with the great uncertainty about the health or well-being of their child as they consider the life long
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implications of caring for a child with this kind of disability. but we know we don't have to accept this as the outcome. we know there's a way to fight it. and that's by preventing the zika virus from spreading to the united states. but unfortunately senate democrats just voted against that. as i said, there are already hundreds of travel-related cases of the virus scattered throughout the country, and i hope the administration does more to underscore the real health threats that exist when people travel to areas where zika is at its worst. that's why i join with one of our house colleagues who is a medical doctor, michael burgess, congressman michael burgess, in asking secretary of state kerry and the centers for disease control prevention director dr. free dan how they are coordinating travel warnings to areas where zika has run rampant. texas and all americans need to
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understand the risk associated with travel to those areas and they need realtime accurate information so they can determine whether they should alter their travel plans. but over the past few months the mosquitoes that carry this virus have been inching their way north and today locally transmitted cases have been reported in puerto rico and throughout the caribbean. in other words, this virus, along with its devastating effect, is at our doorstep. i've had a chance to visit with experts in my state at the university of texas medical branch at galveston and the texas medical center. and they agree this is a major public health concern, and we need to act and act soon. that's why we've got to prepare for the arrival of the mosquitoes that carry this virus in the united states, something that our democratic colleagues have just prevented.
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fortunately, counties and cities throughout texas have already been working hard to counter the spread of the virus. when i was in houston recently, public health officials back in april told me that they were -- told me about measures they were implementing to track and manage the spread of zika throughout the houston area, one of the most populous urban areas in the country and the efforts to eradicate the breeding grounds that transmit the virus. the governor there is making sure we are prepared as possible, but we can't do it alone. and unfortunately, the sort of help that's needed by states like mine for mothers and fathers who could have children like this has just been blocked. governor abbott invited the centers for disease control to sraoufr the state's -- review the state's plan to combat the
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virus and invited the task force to make a plan. in other words, states like mine, communities like houston are doing their part, but senate democrats refuse to do their part. so it should go without saying that now on the front lines of this major public health concern we need to respond at the federal level. that's why it's shocking and shameful to see so many senate democrats oppose this bipartisan effort to guard against the virus, particularly because they have repeatedly called for an expedited resolution of this appropriation request. over a month ago the minority leader made clear that he viewed zika funding a major priority, and he demanded action. this is what he said.
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this is senator reid, the democratic leader, on may 23, 2016. he said "instead of gambling with the health and safety of millions of americans, republicans should give our nation the money it needs to fight zika. and they should do it now. not next month, not in the fall -- now." of course senator reid was advocating bypassing the normal legislative process, and it was really inappropriate for him to demand a $1.9 billion spending appropriation that is, adds to the deficit and debt without letting congress do its job. but now the house and the senate have both passed legislation and agreed to a conference report which senate democrats have now just voted down. senator reid said for us to fail to meet this crisis would be irresponsible, and yet he just
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advocated failing to meet that responsibility and address the crisis. we -p can't gamble with the health and well-being of women and children in this country just to serve partisan political needs. and most of the things that the democratic leader raised in terms of objections to this conference report are just figments of his imagination. there is no mention of planned parenthood in this conference report. i would challenge anybody to find planned parenthood mentioned once. and as the democratic leader knows, planned parenthood is a medicaid provider, and so medicaid-eligible individuals can still seek whatever services they want through medicaid at planned parenthood. and then there is the senator from washington, the top ranking democrat on the appropriations subcommittee, that actually crafted the bipartisan zika
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response. and then walked away from it and voted against it. she said on may 26, 2016, she said "families and communities are expecting us to act. parents are wondering if their babies will be born safe and healthy. in congress, we should do everything we can to tackle the virus without any further delay." well, i agree, and i frankly do not understand how senate democrats, having taken this position previously can come in here and engage in a partisan filibuster to stop funding for this impending public health crisis. and then just last week the senior senator from new york said "every day we wait, every day is increasing the risk that we will have problems with
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zika." well today we had the chance to send a bill to the president's desk that would meet the demands of senator reid, senator murray, senator schumer, but they blocked it for fanciful and imagined reasons. one of the arguments that senate democrats make against the bill is more money is needed. yet, this is funded at the very level that the senate agreed to, $1.1 billion. president obama and our democratic colleagues repeatedly make the argument that throwing money at the problem will fix everything. well, throwing no money at the problem will fix nothing, which is what they voted for today. less than 7%, just 40 million of
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the $589 million transferred from the ebola fund to fight zika has been obligated as of earlier -- early june. that translates to more than $500 million the president can use to fight this cause in addition to the $1.1 billion included in this bill. referred from our colleagues on the other side of the aisle about this great need to prepare this country about this coming health crisis and we've heard how it is to quickly get the resources for those studying the virus and perhaps discovering a vaccine. but when given the chance to do that, democrats shut it down. they filibustered the bipartisan bill themselves. they themselves have been asking the senate to pass, which is absolutely disgraceful. so i hope our colleagues on the other side of the aisle will reconsider their misguided
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efforts and follow through with what they have been saying we need all along, the funding to fight a real public health threat. it's a public health priorities that demands our attention and must be addressed now and not later. mr. president, i wonder what the senators who voted against this bipartisan zika funding bill would tell the mother of this child, or perhaps another woman pregnant wondering whether her child will end up with this virus and this terrible birth defect. could they possible look that woman in the eye and justify the reasons they have voted against funding so that other children can avoid and families avoid this terrible, devastating birth
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defect? i bet none of them could look that prospective mother in the eye and say, well, we voted against protecting your baby and your family for good and sufficient reasons, because, as i said earlier, many of the reasons stated by the democratic leader are imagined and not real, like this idea that somehow planned parenthood has been targeted, which is not even mentioned in the legislation. i can't imagine a more disgraceful vote than what some of our colleagues across the aisle have cast to deny funding for this impending public health crisis. i hope they'll reconsider. i hope the families who worry about the health of their
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children will call their office and say, why did you vote against funding the money necessary to eradicate the mosquitoes that carry this disease? why did you vote against further scientific research to learn how to combat it? and why did you vote against our developing a vaccine that can prevent the spread of this disease, not only here in the united states but around the world? i bet none ever them could look that mother in the eye, because what our democratic colleagues just did today by voting down this funding was absolutely hypocritical, it was cynical, and it was shameful. mr. leahy: mr. president? the presiding officer: the senator from vermont. mr. leahy: mr. president, i
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would have found the previous comments more interesting if it wasn't for the fact that people have been asking me, why is it -- i wonder if i -- i don't want to interfere with the conversations on the floor, but ... mr. president, i just wonder on this if we had had a real conference where things were discussed, which is impossible because the republican leadership took the house of representatives out for a multi-week vacation last week. had they stayed and done their work, as we are, i'm sure we could have worked something i me approved. the presiding officer: without objection. mr. isakson: mr. president, i find it unbelievable that today
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the united states senate said no to pregnant moms and veterans. the vote earlier to deny cloture on the v.a. milcon legislation and the zika virus is to say to pregnant moms in america we don't think the case of the zika virus is that important. you're going to have to run the risk yourself. and say to our veterans that we may not fund your health care. that's just not the right thing to do. i deeply regret the fact that the cloture motion was denied i hope that cloture will be granted so we can approve v.a. milcon and approve our response to zika. in terms of zika, i represent the c.d.c., the centers for disease control in georgia, the world's health care center. i was there two weeks ago for a briefing on the zika virus. there are montana than one million zika cases in latin america, there are zika cases in the caribbean, there are 150 in
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the united states of america. it attacks a pregnant mom, it attacks the child in the womb attack -- attacks the brain and the central nervous system causing terrible brain problems and deformities, something that we hope we can stop and prevent. but you can't do it if you don't fund the nation's response and the $1.1 billion in this motion that was denied today would go towards the zika response. the two real estate sponses we need to -- there are two responses we need to fund. someone for developmental vaccines if we can find them as quickly as possible. but the other is the education to do the most we can to see to it that zika is prevented wherever possible. now, a lot of people think if you don't have mosquitoes, you don't have to worry about zika. zika is transmitted in two very disipght ways. one is through one of two types of mosquitoes, both of which are indigenous to my state of georgia and most of the southern eastern united states. zika is also transmitted by sexual intercourse, which means whether you are in colorado, where there are no mosquitoes, or georgia where there are, there is another way to transmit
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it at well. if we don't have a good education process in terms of how people can protect themselves against the zika virus or protect themselves from the bites carried by the mosquitoes, we are going knob big trouble in this country because we didn't do our job. it is stimulussed that the cost of a live birth and the lifetime of a child born with the affects of the zika virus will be $10 million on the taxpayers of america per child. $10 million. think of the cost that adds up to. we should come to the table immediately and come back and vote again and vote for cloture on the zika virus, the $1.1 billion response nasd the house, passed the senate, to see to it that we tell the american people that we understand the dangers of zika, we're going to do everything we can to allow you the education you can to prevent it, we're going to respond to it and do it in the right way. as far as v.a. is concerned, i have never understood anybody who can look a veteran in the eye and say no. as chairman of the veterans affairs committee in the united
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states senate, i know what these people have done. as one who served in the military, i know what sacrifice means. to say no to the funding of v.a. health care is justen conscionable and wrong. our veterans volunteer. we don't have a draft anymore. we don't conscript people anymore. people volunteer for the military. we've had 16 straight years of deployment in the middle east in the -- in the middle east of americans who volunteered to protect this one country. they deserve to know when they come home, their health care will be provided for, their benefits will be provided for and the promises we made to them to get them to volunteer to join our military are promises we keep for them regardless of the condition they may be or difficulties they have. so as one member of the united states senate, i can't say no to a mom or 00 united states veteran. i would encourage the members of the democratic party to come back to the floor and join all of us in the republican party and vote for cloture on the v.a. milcon and the zika virus agreement and do it as soon as possible. time is wasting.
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