▶ 0:13:28>> uh, we're trying to go on a faster schedule because instead of having two meetings at the same time, we have meetings in the morning and meetings in the afternoon. We used to have two meetings in the morning and then one in the afternoon. Uh, but we're we're truncated a little bit, so we're trying to get started early, which is why the schedule is not matching up for everybody. So we're, we're we're waiting till we have sufficient number of our colleagues on the other side of the aisle here, because this is an important hearing. And we want to make sure that everybody has an opportunity to hear the witnesses testimony. So bear with us.
▶ 0:13:58We're going to be a couple of minutes late getting started. But it's it's all for, uh, trying to make this place operate better. And we're doing the best we can, and it's, uh, nobody, uh, being disrespectful or rude. It's just a matter of us trying to get things done in time for in a time allotted for ten. So we're doing what we can.
▶ 0:15:00>> so. That.
▶ 0:15:55All. The. >> subcommittee will come to order. As I explained a minute ago, uh, we were waiting on some of our democrat colleagues to get here so they could hear the, uh, the witness testimony. They're they're coming in now. Miss degette, the ranking member, is here, and she said we can go ahead and get started.
▶ 0:16:25So I've called the subcommittee to order. Um, and I've got an opening statement, but they probably don't care as much about that one as they do y'all's. So which I appreciate. That's understandable. Um, and so I will now recognize myself for five minute opening statement. Today's legislative hearing will focus on several bills aimed at enhancing seniors access to life saving and life sustaining breakthrough medical technologies.
▶ 0:16:48These policies are essential to reducing regulatory barriers to help patients get timely access to care, while also bringing more transparency into the coverage process. At cms, I think we can all agree that federal agencies can be inefficient at times and very bureaucratic in instances. It is our job as congress to ensure that patients are able to access treatments, screenings and medical devices in a timely manner, especially if there are no other alternatives on the market.
▶ 0:17:18This hearing is the next step in our processes. One of the bills we are considering is h.r. 842, the nancy gardner sewell medicare multi-cancer early detection screening coverage act. This act would establish a new coverage pathway, uh, as cms for multi-cancer early detection screening tests so that once these tests are approved by fda, medicare beneficiaries can access these tests in a timely manner.
▶ 0:17:46This bill has been introduced by representatives arrington and sewell. These multi-cancer screening tests allow for patients to take blood tests, take a blood test to screen for over 50 different types of cancers. This allows us to do additional testing to narrow the results down to one potential cancer, and that yields a low false positive rate. Now, initially you're going to have a higher false positive rate. But then we can bore down.
▶ 0:18:14If we find something, it is essential that medicare beneficiaries can get screened for cancers early and get treated. This can save lives and reduce costs for patients and federal taxpayers. I'm proud to be one of this bill's 300 bipartisan co-sponsors. Another bill being considered today is the ensuring patient access to critical breakthrough products act, which will ensure seniors have timely access to innovative medical technologies.
▶ 0:18:40Many medical devices currently fall into what is known as the valley of death. This refers to the period between fda approval of a device and when medicare covers the technology. During the first trump administration. This led to cms issuing a proposed rule in 2020 titled medicare coverage of innovative technology, or mset.
▶ 0:19:03This pathway would have provided fda approved breakthrough medical devices for four years of medicare, would have provided these breakthrough devices for years of medicare coverage while working on longer term coverage determinations. The goal was to accelerate the benefits of these innovative technologies to benefit patients more quickly.
▶ 0:19:24This rule was repealed in 2021 by the biden administration, was replaced with the transitional coverage for emerging technologies, or pathway they cited. The repeal was due to having unknown or unexpected risks for medicare beneficiaries, which compared to imset and had. But it had many more regulatory hurdles, hurdles and barriers for devices to come to market and is limited to only five new breakthrough technologies each year.
▶ 0:19:51Getting this bill signed into law will bring us closer to the original m-set rule, spurring more innovation in the medical device and in the medical device arena, and enhancing seniors timely access to medical innovations. I personally am frustrated with cms acting more as a scientific regulatory agency than an agency focused on reimbursing for fda approved products. Fda, after all, is a scientific regulatory agency.
▶ 0:20:20That is their mission, not cns's. I'm sure everyone here has heard complaints about the opaque and slow moving national coverage determination process at cms, or had frustrations with local coverage determinations. One of the bills in front of us today will bring more transparency and accountability at cms in both covering in both these coverage determination processes. The final bill being considered today is h.r.
▶ 0:20:443826, the expanding access to diabetes self-management training act by representative schrier and bilirakis. This bill expands access to diabetes self-management training. This training is critical for individuals living with diabetes since it will help them cope, manage, and learn best practices when dealing with their disease.
▶ 0:21:06This bill will help increase the amount of educational opportunities for diabetes wellness training, lower cost for patients, and provide more access to certain services. All of these bills before us today are important to bring more care to patients and achieve better health outcomes. Overall. I'm excited. I mean, I like most of our hearings, but I'm excited about hearing from our expert panelists today to learn more about how they see these bills will work.
▶ 0:21:35And of course, if they have suggestions, we'll take those into account. But I think we're doing some important stuff, and I think that it's critical that we hear from the experts. And so I look forward to it. And with that, I yield back. And now recognize my colleague, miss degette, the ranking member of the subcommittee. Mister, get you're recognized for five minutes. >> thank you so much, Mr. chairman.
▶ 0:22:00As I said yesterday, in the markup that we had, we continue to fiddle in this subcommittee while rome burns. Yesterday, I asked you and chairman guthrie to schedule hearings on the state of our public health system and the damage that the trump administration is doing to cancer research, vaccination, and more. I gave each member of this committee a copy of this new york times story describing the damage that this administration is doing to cancer research in this country.
▶ 0:22:32It discusses the firings at the nih, new burdens on researchers, and the horde of political appointees who are interfering with science. Former nih director harold varmus is quoted saying, quote, we are great in science. Why would we want to destroy one of our greatest assets? Mr. chairman, I'd ask for unanimous consent to enter that article into the record again. >> without objection, we'll enter it again. >> thank you. Sir. Sir, I hope that everyone approaches this hearing and our work going forward with this story in mind.
▶ 0:23:05We also need to recall that we're working on these bills. While we're working on these bills. The administration has halted funding for the pediatric brain tumor consortium, which is dedicated to trials of novel treatments for pediatric brain cancer. And I haven't heard a peep from my colleagues on the other side who controlled this committee's agenda and activities. Here's one hearing we should be having today.
▶ 0:23:29We should be talking about the cuts to the nih, fda, cdc, and our nation's other critical health care agencies. The committee should be examining directives from the administration that have delayed or completely halted critical work, and all of us should be examining.
▶ 0:23:46We should be talking about the impact this is having on our constituents from people who need help today, because years down the line, who won't get a cancer treatment because the administration thinks that harvard university is too liberal. Let me be clear. I support working on these bills today, and I hope we can get them all to a good place. But we need to examine what's happening in the real world as we consider them.
▶ 0:24:13The nancy gardner sewall multi-cancer early detection screening coverage act will make new cancer screening tools more accessible to seniors. I support that. Meanwhile, the nih clinical center has been described to me as being in, quote, critical shape, and shifts in funding at the nih mean that only 4% of the national cancer institute grant applications are going to get funded in this fiscal year.
▶ 0:24:40The ensuring patient access to critical breakthrough products act will speed medicare beneficiaries access to promising new medical devices, and that's good. But meanwhile, doctor, yesterday, doctor susan jahana hayes testified to a senate committee that secretary kennedy had directed her to endorse ideological recommendations created by a sham advisory committee on immunization practices. Regardless of the evidence backing them up.
▶ 0:25:08We're also considering a bill on national coverage, determinations and local coverage determinations, tweaking the statutes associated with both. Meanwhile, the trump administration is narrowing access to covid 19 vaccines without any data to support the decision and seemingly overriding career staff at the fda.
▶ 0:25:29And we're considering the expanding access to diabetes self-management training act, which is a great bill to help medicare beneficiaries with diabetes take better charge of the disease. As the co-chair of the diabetes caucus, Mr. chairman, I love this bill.
▶ 0:25:45But meanwhile, the trump administration has proposed to eliminate the national diabetes prevention program at cdc, a program that is proven to help people with prediabetes avoid progression to type two diabetes through lifestyle changes. This is in addition to sweeping layoffs and program cancellations at cdc, including the gutting of acip.
▶ 0:26:10Secretary kennedy is undermining science, dismantling research and development in our country and making lifesaving vaccines harder to get. I just want to add on a personal note. Last night I was at the banquet for friends of cancer research, which has many of the preeminent researchers and and former heads of the nih and the and and hhs from both political parties. The mood was somber.
▶ 0:26:41People are distraught about what is happening to what was once the crown jewel, the crown jewel of biomedical and cancer research in this country. And I won't stand still. I keep doing this every hearing, and I'm not going to stop. So once again, Mr. chairman, I want to ask you, will you hold a hearing on these cuts the week of october 6th? >> thank the gentlelady. Yields back. >> and you're not going to answer my question.
▶ 0:27:11>> I'm not going to answer the question because I don't have the answer. But, uh, but october 6th is coming up, and we'll see what we'll see what we can get on the agenda. I appreciate it and always appreciate the gentlelady from colorado. Now, recognize the gentleman from kentucky, the full chair of the committee, chairman guthrie, for his five minutes for an opening statement. >> thank you, chairman griffith. And thank our witnesses for being here. And I want to have a special call to my friend kim lundgren, who's here representing the american cancer society.
▶ 0:27:38She's a good friend of mine, and we've gotten to become good friends through her advocacy. So through advocacy, you can get to know your member of congress and have a great relationship. So thanks for being here from back home, back in my hometown. So I want to start today by during the 118th congress, this committee carried out critical work on policies to bolster seniors access to the latest breakthrough medical technologies and to reform medicare coverage pathways.
▶ 0:28:06Today, we are continuing the conversation by examining several important policies that would enhance medicare's coverage of fda approved breakthrough devices, allow for medicare coverage and multi cancer and early detection tests, and provide for common sense reforms in the medicare, national and local coverage determination process.
▶ 0:28:26In the last several years, we have seen tremendous advances in medical technologies that can change the trajectory of patients outcomes for the better. With multi-cancer early detection tests, for example, we have an opportunity to opportunity to identify early stage cancers and begin treatment sooner, helping to improve cancer related mortality rates and reduce the economic burden of later stage cancer treatments. And I mentioned my friend kim coming.
▶ 0:28:56This is one of the policies she always brings up when we come. And I'm proud to see today these are moving forward under the leadership of chairman griffith in this committee. Um, one of the policies we're we also are considering is ensuring patients access to critical breakthrough products and would help address this issue by providing four years of transitional medicare coverage for breakthrough devices.
▶ 0:29:18Further, we will also discuss improvements to the medicare national coverage determination process with the policies we are considering today. Building on the committee's work from last congress, providing greater accountability at cms, and ultimately more confidence in this process for patients, providers and innovators. I thank all the witnesses for being here. I think for the advocates, for being here today. It's a very important the work that you do and what you support, and it means a lot to have your presence today. I thank you and I yield back.
▶ 0:29:51>> gentleman yields back. And now recognize, uh. >> he's the vice. >> the vice ranking member or whatever his title might be. Mr. uh. Ruiz. Thank you. She she said your first name earlier, and I think. Wait a minute. I can't recognize his first name, so. Yes, but thank you, doctor. Yeah. >> that's right. Thank you. Uh, Mr. chairman, I'm giving opening remarks on behalf of our ranking member, frank pallone.
▶ 0:30:20Uh, president trump and congressional republicans have created a healthcare crisis and waged a war on the american health care system since the beginning of the year, president trump and congressional republicans have launched attacks on americans health care, dismantled our public health, and ripped away coverage from millions of americans. They are now continuing to put fuel on the fire and marching forward toward a government shutdown.
▶ 0:30:46And I call on my republican colleagues to stop the chaos and instead work with us to lower healthcare costs for working people. President trump and congressional republicans big, ugly law cuts more than $1 trillion from our healthcare system and takes coverage away from 15 million people already.
▶ 0:31:05Just two months after enactment, we are hearing from hospitals, clinics and nursing homes across the country that have been forced to close their doors and cut services in rural lavonia, georgia. Saint mary's sacred heart hospital just announced that it will shut down its maternity unit next month, pointing to, quote, recent congressional cuts to medicaid. That's a fact. It's happening. It's not hyperbole. We're not making it up. It's not fake news.
▶ 0:31:35They're cutting their maternity ward next month due to recent congressional cuts to medicaid. That means expectant mothers who qualify for medicaid or who have private health insurance are now traveling further because republicans claimed that medicaid payments for birthing babies is, quote, waste, fraud and abuse, unquote.
▶ 0:31:59Another example in rural virginia, augusta medical group is closing an urgent care and two primary care clinics, again citing their, quote, ongoing response, unquote, to republicans big ugly law. You know, this is only the beginning. It's only going to get worse unless we reverse these devastating cuts. Congressional republicans are also taking away tax credits that help pay for millions of americans health care bills.
▶ 0:32:30Thanks to the enhanced tax credits included in the inflation reduction act, a record breaking total of 24.3 million americans have coverage through the aca marketplaces. Millions of families have been able to afford health care and have seen the cost of their monthly insurance premiums go down. Well, that's adding 24.3 million americans.
▶ 0:32:51Health coverage through the aca marketplace really them off, because republicans are not actively taking away these tax credits, and health insurance premiums are about to skyrocket for millions of working families. So I must also comment on this committee's lapse and oversight on the devastating actions by secretary kennedy as he remakes the department of health and human services into his personal anti-science and anti-public health soapbox, and manufacturers and national vaccine crisis.
▶ 0:33:20As I am speaking, the advisory committee on immunization practices is meeting to vote despite years of scientific evidence and against the clinical guidance of major provider associations and outside experts to restrict or after or alter life saving vaccines for children and adults. See these decisions.
▶ 0:33:41As a former cdc director testified yesterday, will cause the resurgence of preventable disease. As we have seen with measles, and will undoubtedly, quote, have children harmed by things that we know they do not need to be harmed by, unquote.
▶ 0:34:05So every district represented on this committee will be affected by the shameful, politically driven, predetermined actions by rfk's hand-picked advisory committee on immunization practices members. This is not a drill. This is real. This is happening in our nation. With that, I yield back. >> gentleman yields back.
▶ 0:34:33Uh, that now concludes our members opening statements. The chair would like to remind members that pursuant to committee rules, all members opening statements will be made a part of the record. We want to thank our witnesses for taking time to testify before the subcommittee today, although it is not the practice of this subcommittee to swear in witnesses, I would remind our witnesses that knowing and willingly making materially false statements to the legislative branch is against the law under section.
▶ 0:34:59Under title 18, section 1001 of the united states code, you will have the opportunity to give an opening statement followed by questions from the members. Uh, and those opening statements are five minutes and their lights down there that will give you the warning signal. And and then when time is up, um, our witnesses for today are doctor todd brinton, md, corporate vice president of advanced technology and chief scientific officer, edwards life sciences.
▶ 0:35:25Stephen ezell, vice president of global innovation policy and director of center for four life sciences, innovation, information technology and innovation foundation. Roger royce, patient advocate and partner at haynes and boone llp.
▶ 0:35:45Doctor diana zuckerman, phd, president, national center for health research, and they david lipschitz, jd, co-director of law and policy, center for medicare advocacy. Her committee custom each witness will have the opportunity for a five minute opening statement, followed by a round of questions from members.
▶ 0:36:09The light on the timer in front of you will turn green from green to yellow when you have one minute left, and then from yellow to red when your time is out. I now recognize doctor todd brinton for his five minute opening statement. You turn the mic on if you'd restart his time for me. Sorry about that. >> so good morning, chairman guthrie, ranking member, pallone, subcommittee chair, griffith and subcommittee ranking member, degette. And distinguished members of this committee.
▶ 0:36:39I'm todd britton, the chief scientific officer of corporate vice president of advanced technologies for edwards lifesciences, the leading global structural heart innovation company driven by passion to improve patients lives. On behalf of edwards, we applaud the committee for recognizing the importance of ensuring medicare beneficiaries access to life saving breakthrough technologies. I'm honored to testify before this committee for the second time in two years on this topic. My perspectives and expertise are rooted in the background as a clinician, entrepreneur, and innovator.
▶ 0:37:05And as an interventional cardiologist, I've witnessed countless patients facing life threatening cardiovascular conditions with limited or no treatment options. My journey ultimately led me to edwards, where for the past six and a half years, I've supported our mission to bring life saving innovations to patients as quickly and responsibly as possible.
▶ 0:37:21We back this commitment by investing 17% of our revenue into r&d, allowing us to pioneer first in class, innovative technologies, beginning with the challenges facing many innovators, the innovation cycle for medical technologies, from identifying unmet clinical needs to entry authorization is a rigorous and sometimes decades long process. Yet even following fda approval, medicare coverage often lags, creating what many call the valley of death.
▶ 0:37:45This delay and uncertainty stifles innovation and, more importantly, denies beneficiaries access to life saving therapies. Transitional coverage policies offer a promising bridge. These policies must be paired, though, with clear post breakthrough coverage pathways and an efficient ncd process to ensure continuity for beneficiaries. Next, I'll share insights as a set pilot.
▶ 0:38:06Specifically, edwards had the opportunity to engage with cms on the set pathway with their evoke transcatheter tricuspid valve replacement technology. Evoke is an example of a truly innovative and life changing therapy for patients with no treatment options. Patients with tricuspid regurgitation or tr frequently suffer terrible quality of life and marry a medicare patient with tr from bellingham, washington, described her quality of life as being, quote, merely a fixture in her house and was unable to participate in even the most basic daily activities.
▶ 0:38:36Following her tricuspid valve replacement, she experienced a complete quality of life transformation. Mary's story highlights how timely access to breakthrough technologies radically transforms patients lives. Edwards began our our coverage journey to ensure access to patients like mary under parallel review in 2020 through ongoing discussions with fda. Mass and nct was finalized in march of this year and has already demonstrated the positive impact national coverage of breakthrough technologies can have on patient access.
▶ 0:39:04Our experience under tset has yielded valuable insights to inform and expanded transitional coverage pathway, and edwards supports a legislative approach that incorporates the following features. Coverage of fda authorized breakthrough technologies that are within existing medicare benefit category. A look back period for technologies that received fda authorization within the past two years, and consistent coverage for medicare advantage beneficiaries and funding to implement this program. Now let's me share how the ncd process should be modernized.
▶ 0:39:34Coverage is not only essential for breakthrough technologies early in innovation cycle, but it's equally important to maintain or expand coverage for existing, truly innovative therapies. Innovation is a powerful, iterative process. It is not an endpoint. As such, many technologies continue to evolve through expanded indications, improved delivery methods, and new clinical evidence. Yet the ncd process often lacks the ability to keep pace.
▶ 0:39:56As an example, edwards has engaged productively with cms and fda for over a decade to advance tavr technologies to treat aortic stenosis or as another debilitating valve disease. The tavr entity was first issued in 2012, allowing initial patient access and revised in 2019.
▶ 0:40:13However, today's as patients face significant delays and obstacles and assessing or accessing tavr due to an outdated coverage policy and cumbersome reconsideration process, these delays in treatment result in higher patient mortality rates and higher costs for the medicare program. Although evidence supports the urgency of tavr, ncd reconsideration and its strong, we believe that nc process has slowed in recent years due to resource limitations and an outdated coverage process.
▶ 0:40:40Edwards recommends that congress work with the agency to create efficiencies, improve transparency and predictability, ensure sufficient funding to improve this consideration. Reconsideration process. In conclusion, I commend members of this committee for proposing legislation to improve timely patient access to life saving breakthrough technologies and to modernize the ncd process. I urge the committee to move quickly and enact legislation this year. Thank you. >> gentleman yields back. Thank you.
▶ 0:41:09Uh, when you go back to watch all this on c-span later, you're going to see there were some technical difficulties. So you were only on camera for about half of it, but your voice was very clear. And we appreciate that. Further. We're having technical difficulties with miss digit's, uh, microphone. So we're trying to fix that while we're doing this as well. But, um, we appreciate all of your testimony, and, uh, we'll hope that these, uh, will now cease, uh, all these little glitches that we're having this morning with that, uh, Mr.
▶ 0:41:37Easel, uh, you're recognized for your five minute opening statement. >> good morning, chairman griffith, ranking member degette and members of the committee, I appreciate the opportunity to testify today. I commend the subcommittee for examining the critical issue of expanding seniors access to breakthrough medical technologies. Perhaps the biggest opportunity standing before congress today is passing the bipartisan nancy gardner sewell, medicare multi-cancer early detection or screening coverage act.
▶ 0:42:04Let me explain why this would be so consequential. Cancer remains an implacable enemy. Unfortunately, I'd wager that every single person in this room has had their lives or those of loved one affected by cancer. Cancer claims over 600,000 american lives annually, and the disease hits seniors especially hard, with those over 65 accounting for 60% of diagnoses and 70% of fatalities. 1200 medicare beneficiaries are diagnosed with late stage cancer each day. That's 50 seniors an hour.
▶ 0:42:34Beyond the pain that cancer inflicts on individual health, it also exacts enormous economic cost. Cancer care alone costs the us economy over $200 billion annually, and analysts estimate that medicare will spend $1 trillion on cancer care over the next decade alone. Unfortunately, cancer is still beating us.
▶ 0:42:55While the age adjusted death rate per 100,000 americans from heart disease fell by two thirds from 1950 to 2010, the similar rate for cancer just barely decreased. Now, that's largely because the former committee chose to focus, especially on screening and prevention. Yet only five types of cancer breast, cervical, colorectal, prostate and high risk lung currently have guideline recommended screening options available.
▶ 0:43:22Today, 70% of us cancer deaths result from cancers for which no proven screening test exists. Thus, the unfortunate reality is that the vast majority of cancers are detected when patients arrive at a doctor's office manifesting problematic physical symptoms. But it does not have to be this way.
▶ 0:43:41A revolutionary new generation of multi-cancer early detection screening test offers the ability, through a simple blood draw, to detect the presence of up to 50 different kinds of cancer, with a very high rate of accuracy and low false positive rate. The technology uses artificial intelligence and genomic sequencing to identify dna fragments shed by cancer cells in the bloodstream.
▶ 0:44:06These tests, which are complementary to existing guideline approved tests, are poised to transform cancer screening from an organ by organ site by site to a whole body approach, with the potential to screen for cancers in the asymptomatic population. In short, multi-cancer early detection test can help catch more cancers, catch them earlier, and thus save lives and save cost.
▶ 0:44:31That's borne out by the fact that detecting cancers at earlier stages can give patients a four times greater chance of survival, and in the medicare population, cancer costs are up to seven times higher for patients diagnosed at later, as opposed to earlier stages.
▶ 0:44:49Multi-cancer early detection tests are also less invasive, relying on a simple blood draw and thus more accessible, especially for patients in rural communities who may not enjoy ready access to healthcare clinics or equipment such as computerized tomography.
▶ 0:45:06And that matters when cancer fatalities in america's rural communities are 14% higher than in urban ones, and black americans continue to suffer a disproportionate share of cancer fatalities, congress has a long history of acting to create medicare coverage for cancer screening, most recently when the 1997 balanced budget act added prostate and colorectal cancer screening benefits to medicare coverage.
▶ 0:45:32In doing so, congress unleashed the flourishing of a multitude of innovative colon cancer screening tests, with far more available today and colorectal screening rates exceeding 50%. A similar opportunity stands before congress now to help unlock a new field of multi-cancer early detection cancer screening that we can hopefully look back upon 20 years later as a turning point that revolutionized america's approach to cancer detection.
▶ 0:46:00Etf thus urges congress to pass the bipartisan medicare multi-cancer early detection screening coverage act. It creates the authority for cms to use an evidence based process to evaluate whether to provide coverage for blood based tests after they received fda approval. The legislation does not mandate cms coverage, but it gives the agency authority to extend coverage should it decide to do so.
▶ 0:46:27Multi-cancer early detection heralds the potential to transform america's cancer screening paradigm for the good of america's individual, public, and economic health. It's time for congress to act. Thank you gentlemen. >> yields back now recognize Mr. roger royce for his five minute opening statement. >> okay. Thank you, members of the committee. And good morning. My name is roger royce. I'm a startup lawyer in palo alto, california. But that is not why I'm here today.
▶ 0:46:53I am here today as a patient to tell you about my experience. Um, I will say I'm here on my own behalf, but I am active with cancer patient lab, pancreatic cancer action network, uh, blood cancer united. Um, and I, I'll tell you, I've run, swam and biked a lot of miles for the american cancer society as well. So, uh, and all of this is fairly recent, uh, as of the last three years.
▶ 0:47:17Now, before I start, I want to mention that coincidentally, today happens to be my birthday, and normally I wouldn't even think about that. But for the last three years, birthdays have become a really big deal for me. Because three years ago, I was diagnosed and found out that statistically, I wasn't likely to have very many more. But as it turns out, I'm still here. Um, and let me tell you why.
▶ 0:47:41So in june of 2022, uh, I took a liquid biopsy of multi-cancer early detection test. Uh, I had no symptoms. I had no signs. I had no risk. Well, I thought I had no risk factors, but I did have one really big one, and that's age. I was 62 years old at the time, but no other indication. I took it as just to check a box and it turned back.
▶ 0:48:07It came back positive with a signal for pancreatic cancer, and within a couple of weeks I was diagnosed stage two pancreatic cancer. At that time, the five year survival rate for pancreatic cancer was 12%, currently 13%. We've gone from 7% to 13% in the last ten years. So we've made some progress. But that's not a very good survival rate. Uh, as it turns out, I was caught at an early stage. It was localized, meaning that my survival rate instead of 13% was 44%.
▶ 0:48:36And I went through treatment. I went through chemotherapy and surgery, and I did a novel neoantigen peptide vaccine through an fda expanded use or compassionate use expanded access program. And I finished that up last june. And as of june of 2025, my doctor now tells me that I am likely cured, likely cured of pancreatic cancer. Thank you very much.
▶ 0:49:15Now, my radiologist tells me that because of where my tumor was and how it was growing, I never would have known until the last months or weeks of my life. I never would have had any symptoms. I only caught this through multi-cancer early detection. This is something that saves lives and not to make well, to make a not to make too fine a point on this, but I do want to mention another story that goes hand in hand with this.
▶ 0:49:43I was diagnosed in june 2022. I did what every cancer patient does when they get a liquid biopsy. Uh, and something like this happens. I called everyone I knew and I said, look, you need to do this too. And I told my family and a lot of people did. Some people got resistance from their medical professionals. My older brother in spokane, washington, uh, he did not. Maybe it's because he saw what I went through with chemotherapy. Maybe it was because of the cost. Uh, you know, it's $1,000 cost for these tests.
▶ 0:50:12Um, maybe it's because he didn't get around to it. But in february, as I was finishing up my chemotherapy, he was wheeled into the emergency room with a stage four lymphoma. He died nine months later of a cancer that is mostly curable. Uh, I survived a cancer that is mostly fatal. And the one big difference is I caught mine at an early stage. He caught his at a late stage. So I think that early detection has saved my life.
▶ 0:50:41And I think my brother would still be here today as well, if he would have had access to this or would have gotten this test. Now, I want to tell you that the two big factors in this, like I say, the big risk factor is age, the average age of a cancer patient in this country, of which 40% of us are going to be someday. By the way, average age, age is 67. It's a huge risk factor. And for people at that age, sometimes this cost is a factor. And that's why I really support this multi-cancer early detection legislation.
▶ 0:51:10I have an extraordinary result, and I want to make the result that I had an ordinary result. So I urge you to pass this bill. Thank you very much. >> wow. Gentleman yields back. Doctor zuckerman, your five minutes. You're now recognized for your five minute opening statement. >> thank you. Chairman griffith, ranking member degette and members of the committee for inviting me today.
▶ 0:51:36I'm doctor diana zuckerman, president of the national center for health research, a nonprofit think tank that uses research to improve the quality of medical care in the united states. I was previously a faculty member and researcher at vassar, yale, and harvard, and most important, a committee staffer in the house and senate. Both the breakthrough devices act and the nancy gardner sewell act require medicare coverage for specific medical devices.
▶ 0:52:05Keep in mind that the standard for medicare coverage is reasonable and necessary for medicare patients, but fda safety and effectiveness standards are not specific to medicare age patients. Fda requires prescription drugs to be proven safe and effective, almost always based in a clinical trial of patients.
▶ 0:52:29But in contrast, the fda requires less than 5% of medical devices to be tested in clinical trials, while more than 95% go through a less stringent review called the 510 k pathway.
▶ 0:52:44These devices are cleared for market if the device is substantially equivalent to a device that's already on the market, even though that other device was also not proven safe or effective in clinical trials.
▶ 0:53:03Medicare almost always pays for prescription drugs approved by the fda, but it does not pay for all medical devices, especially if there are no clinical trials and if there is no evidence that they're safe or effective for medicare patients. When I served on cms's advisory committee that recommends whether products should be covered by medicare, I saw many devices that were not covered because they had never been studied on medicare age patients.
▶ 0:53:33Age is important for implants and many other devices because the older we are, the more likely we are to have chronic health conditions that make surgery, anesthesia, and other treatments much riskier. So the risks then outweigh the benefits.
▶ 0:53:50Devices are designated as breakthrough before scientific evidence is available, and it's based on fda's belief that the device will be more effective than other available devices. But if the completed studies show that the device is not more effective than other devices, or even if it's less effective, it will still be sold as a breakthrough device.
▶ 0:54:18Most of the 160 breakthrough devices available in the united states are therapeutic devices to treat a disease or condition, and almost half of these treatment devices are cleared through that 510 review as substantially equivalent to devices already on the market.
▶ 0:54:41Of these 49 devices, currently called breakthrough, only eight, 816% were studied in clinical trials that were listed in clinical trials as required by law. One of those eight devices excluded patients over 63 years of age from its clinical trial, and most of those studies do not make the age of their study participants publicly available.
▶ 0:55:12But two devices were studied on patients who averaged 37 years of age, so they were unlikely to include many medicare patients. And that means that five at most five of these breakthrough devices, that's 10% would qualify as reasonable and necessary for medicare coverage.
▶ 0:55:33The other 55% of breakthrough five devices either had non clinical data, such as animal or mechanical mechanical data, or had some kind of clinical data that were not that was not clinical trials data. And some data were based on the previous predicate device, not on the new device. There were 60 other breakthrough treatment devices that went through more stringent.
▶ 0:56:00The more stringent pma or de novo reviews, and many of those did have clinical trials. But many of these studies were small. They had no placebo or comparison group, and many did not include medicare age patients or did not publicly report the age of the patients that were studied.
▶ 0:56:23As a cancer survivor, I appreciate that the goal of the nancy gardner sewall screening bill is to save lives, and I know that sometimes it does. Multi-cancer early detection tests are so promising, but they're not quite ready for prime time yet.
▶ 0:56:39The most recent research, in a study that just came out this week, has concluded that the existing tests are subject to bias miss most early cancers in people who do not have symptoms, and may provide false positives to most patients. In one of these tests, a test result indicating cancer was correct. Only 4% 4% of the time.
▶ 0:57:06I agree with the article on the american cancer society website that a test with many false positives, where many patients who are told they may have cancer do not have cancer, causes anxiety and results in additional testing that may be painful, harmful, expensive, time consuming and stressful.
▶ 0:57:30A test with many false negatives in which patients are told that they do not have cancer when they actually do have cancer, is likely to result in patients who ignore signs and symptoms of cancer, and thus delay needed treatment. Nci recently launched the vanguard study of 24,000. >> doctor zuckerman. >> if you could. >> wrap up your about a minute and 23 over right now. >> I'm so sorry. >> that's all right.
▶ 0:58:01>> I just want to say if in the future these tests are proven to have benefits that outweigh the risks, I'll be the first one to support it. Um, but I strongly urge that the age restrictions be deleted from the bill because they set a dangerous precedent for medicare coverage decisions, and they would certainly cause an uproar among patients who are excluded from coverage for reasons that are not scientific and will be perceived as unfair. I'm so sorry for going over. Thank you. >> all right. We appreciate you.
▶ 0:58:32Thank you so much. Uh, Mr. uh, lipschitz. >> chairman griffith, ranking member, degette, chairman guthrie and ranking member pallone. And distinguished members of this committee, thank you for the invitation to testify today. My name is david lipschitz. I am the co-director of the center for medicare advocacy. We are a national, private, nonprofit, nonpartisan organization that works to advance access to comprehensive medicare coverage and quality health care.
▶ 0:59:00Our policy work is based on the real life experiences of beneficiaries and families. We hear from every day. Our health care system is in dire need of reform, including medicare. We have many ideas about how to do so, some of which I'd like to touch on.
▶ 0:59:17But first, I'd like to address the bills at issue in this hearing today, we have no concerns about either the proposed bill regarding the national coverage determination process or the bill self-management training. We do, however, have some concerns about the other two bills and would like to provide the following feedback.
▶ 0:59:37The nancy gardner sewell multi-cancer early detection screening coverage act would allow medicare to cover emerging blood based cancer screenings that are fda approved and determined to be reasonable and necessary by the medicare program.
▶ 0:59:51Aside from the question whether or not such tests currently meet clinical standards, we are significantly concerned about the built in limitations to accessing care and the precedent such limitations would set for purposes of expanding medicare coverage or expanding coverage in the medicare program. The legislation limits coverage to medicare beneficiaries who attain a certain age by january 1st of a given year.
▶ 1:00:15If enacted, starting in 2028, coverage would be available only for individuals who turned 68 years old or younger than that, with this age limitation increasing by one year each succeeding year. In other words, eligibility for coverage of these cancer screenings would be phased in over time based on age, leaving millions of medicare beneficiaries behind in the process.
▶ 1:00:39While medicare does account for some age based risk factors with respect to certain or coverage of certain preventive and screening tests, such considerations are based on clinical evidence factoring in both the condition and question, and the type of preventive test or service. The arbitrary age cutoff contemplated in this bill, however, is based solely on cost rather than clinical consideration.
▶ 1:01:05All beneficiaries should have equitable access to medicare services that are appropriate for them based on their medical needs, not based on the year of their birth. The ensuring patient access to critical breakthrough products act would allow fda designated medical breakthrough devices to be covered under medicare during a four year transitional period from the date of fda clearance. During that period, these devices would be deemed to be reasonable and necessary.
▶ 1:01:34Despite not going through medicare's usual process of determining if complete evidence of efficacy, safety, or clinical benefit for use among medicare beneficiaries has been met. This standard is a critical consumer protection tool that protects beneficiaries health and well-being. A pathway introduced by cms last year allows for more streamlined access to new technology, while retaining the ability of the agency to protect beneficiary safety and protect the program from fraud.
▶ 1:02:02In an effort to balance between getting innovative, potentially helpful products to people who might need them and ensuring that such products are safe, effective, and medically reasonable and necessary. We have concerns that this bill does not strike an appropriate one. We appreciate the committee's focus on access to care for medicare beneficiaries.
▶ 1:02:23And in addition to the above feedback on the bills addressed at this hearing, we would like to offer some suggestions for improving access to care for medicare beneficiaries and safeguarding the medicare program. Further discussed in our written testimony. In short, congress should increase oversight of medicare advantage plans.
▶ 1:02:41We regularly assist medicare advantage enrollees who have had medically necessary care denied, delayed, or prematurely terminated areas ripe for redress include abuse of prior authorization practices, limited provider networks, and marketing misconduct.
▶ 1:02:57At the same time, ma plans are significantly overpaid to the tune of at least $84 billion a year, according to medpac, due to rampant upcoding and flawed quality bonus program, congress can recoup and redirect this money toward strengthening traditional medicare, including adding an out-of-pocket cap and adding dental, hearing and vision services, among other improvements.
▶ 1:03:20In addition, in order to foster public health and access to care for medicare and medicaid beneficiaries in the broader population, congress must reverse the harmful cuts to healthcare from the recently enacted h.r. One reconciliation bill. There are direct negative impacts on medicare beneficiaries because of this bill further outlined in my written testimony. Thank you again for the opportunity to testify. I look forward to your questions. >> thank you very much. And we now turn to questioning section.
▶ 1:03:54Um, I'll ask members not to begin. Just caution yourselves not to begin a new question to our witnesses as your time is expiring, because then the witness doesn't have time to answer without bleeding into somebody else's time. So we would encourage members to watch the clock and not ask questions right at the end of their five minutes. Members may submit as, as you all know, written questions for the record, and you can do that if you have more questions, which oftentimes we do. I now recognize myself for five minutes.
▶ 1:04:24I appreciate the witness testimony. Um, you know, this is why we have hearings. I'm a big fan of the cancer screening. Um, but, you know, I am concerned and we're going to have some discussions about the age, uh, limitation, uh, being 67, that concerns me, because by the time this actually gets to be law, it might not qualify.
▶ 1:04:47Um, but, uh, but nonetheless, these are this is why you have hearings so you can hear the good and the things that might need to be improved in the bills that are before us. I am a big fan. Uh, Mr. royce, for the reasons you stated. Uh, there are a number of cancers out there that you don't find until the last minute. And, uh, unfortunately, I'm told that pancreatic is is one of the big ones. Uh, ovarian is another, uh, as I'm told.
▶ 1:05:11And you can't find them till the last minute, so I'm okay with, um, false positives as long as people understand there are a lot of false positives, I think we can deal with that. Uh, people need to understand when they're doing these tests that there are more false. And I know Mr. rozelle is going to tell us they're not that high on the false positives, but I'm okay with false positives as long as people know, get the additional testing and that you may find out that you don't have that cancer, because if you don't have the cancer, you don't need to get the treatment. But, Mr.
▶ 1:05:42Zell, I'm going to ask you about the false negatives that that we've heard about, because false negatives concern me because there are too many people that get will get a false negative and think they don't need to pay attention to whatever other symptom they might be having. Uh, so if you will explain to us, uh, about the false negatives and, and how you can safeguard against a false negative.
▶ 1:06:10>> I think what is most exciting about these technologies, you know, if you think about the car today, the car has become a computer on wheels. It goes through an innovation cycle very rapidly. So as we are now bringing information technologies like machine learning and artificial intelligence, it puts us on that kind of exponential scale like we've seen in semiconductors, where their power doubles every two years as our cost halves.
▶ 1:06:35So what I'm driving at is that the nature of these information technology, learning based systems are going to give us the ability, over time, to address these mutual challenges of the type one and type two errors. Right. >> and so. >> the the false positives.
▶ 1:06:52>> if I might simplify your analogy, what you're saying is when we first invented the automobile, uh, all kinds of things were developed and they didn't even know they needed a windshield at first until they started driving a little bit faster and all kinds of bugs and debris started getting in people's eyes, and then they created a windshield. But the early cars didn't have it. And until we get the devices on the market, we can't figure out how we can make them better because we don't know what all the the difficulties might be. But at least we're getting something on the market.
▶ 1:07:18And correct me if I'm wrong, because there isn't anything out there now to test for most of these cancers, you're just flying blind and at least you have, whether it be a false positive or a false negative. But I'm I'm more concerned about the false negatives and giving people assurances. Then you got to get them out there. We can get them better as we move along. I agree with that. But we probably need to have some very significant discussions about how we warn people about both false positives and false negatives. False positives.
▶ 1:07:48You get more tests. False false negatives doesn't mean you don't get more tests if you're showing symptoms of something. Is that correct? >> yes. I'd also add maybe two more points to that. You know, first, right now, the way we do cancer detection in the united states or cancer screening is like we have five fishing rods that we cast out for prostate, colorectal, cervical, high risk lung. Uh, so we're just using five fishing poles to try to catch cancer.
▶ 1:08:15What these multi-cancer early detection tests give us the ability to do is to cast a broader net that will hopefully enable, enable us to capture many more different types of cancer. >> so it's getting close to the end of my time. I will ask this a whole lot cheaper to do the tests and catch the cancer early than it is to catch the cancer late, isn't it? >> right?
▶ 1:08:39And the medicare population, it's seven times cheaper treatment at the earlier stages than when cancer is caught at the later stages. Also, maybe just one more key point about these tests is that they're specifically designed to try to, uh, you know, to identify these circulating tumor dna that floats in the body. They're looking for the most aggressive cancers that are shedding of the most ctdna.
▶ 1:09:05If you look at pancreatic cancer, uh, it can progress through disease states as quickly as one stage per year. And these aggressive cancers shed many cells in the body. That should help us to be more specific in what we're looking for in these tests and to decrease those false negative rates you're addressing. >> all right. Well, we've got to get these bills into the right order. I appreciate all of your testimony and helping us do that. And with that, I yield back and now recognize Mr. degette, the ranking member, for her five minutes of questions. >> thank you so much, Mr.
▶ 1:09:35Chairman. And, um, um, I think we can all stipulate that america leads the world in biomedical research. And that's thanks to the incredible scientists at the nih, in industry and in universities around the country, including in my backyard at the university of colorado anschutz medical center.
▶ 1:09:54And, and and this is all because of a long standing, bipartisan, bicameral commitment from congress to fund and foster science and research that leads to incredible breakthroughs. And like Mr.
▶ 1:10:09Royce, when I hear your testimony, it just makes me so proud to have been a part of this congress for so long and funding these these research innovations that lead us to being able to treat and even cure cancer. So. Mr.
▶ 1:10:24As I listened to your testimony with great interest, and I share your excitement about all the achievements we've seen since the 1990s, cancer death rates in the united states have fallen by 27%, is that correct? >> yes, ma'am. >> and what that means is that's 2.9 million lives saved, is that correct? >> yes, ma'am.
▶ 1:10:50>> and new treatments in medicines and detection services are responsible for most all of that decline. Isn't that correct? >> well, certainly a combination across our society of decreases in smoking, of early detection. >> and also. >> public health. That's have all contributed. >> to those. And I think we can all agree that that's not that's great. It's not enough. We need to keep working on it. Right. We need we need to try to reduce cancer deaths even more. Right? Mr.
▶ 1:11:21>> when we have 600,000 american fatalities from cancer each year. Yes. >> yeah. >> and 40% of us are gonna experience this in our lifetimes. >> would anybody on this panel disagree with that? We need to we need to be act with urgency to decrease cancer deaths even more. Everybody's nodding their head now. I want to focus on one of the therapies that you mentioned, keytruda, in your written testimony, which is an immunotherapy that treats several different kinds of cancer. Mr.
▶ 1:11:47Do you know about how much nih funding contributed to the development of keytruda? I'll tell you, according to an analysis by a bentley university professor, the nih spent over $2.8 billion on the basic research underlying keytruda.
▶ 1:12:06And what's more, nih research undermine underpinned 354 out of 356 of the drugs approved by the fda between 2010 and 2019. Because what happens is that the nih does the basic research and then private industry, the pharmaceutical companies and so on. They're able to develop it, give it to patients and monetize it.
▶ 1:12:35So so my opinion is and I think actually this opinion is probably shared by everybody on both sides of this dais. This is not a research system that's failing. It's a research system that needs our support. But yet secretary kennedy and the trump administration are gutting research. One example, as described in that famous article I keep talking about in the new york times from sunday, is rachel suriani.
▶ 1:13:02She's a pediatric brain cancer researcher, and she's doing innovative research on on pediatric brain cancer. She had to shrink her lab and suspend one of her most promising trials due to this administration's assault on research. And and I am spending every day and every night, and my colleagues will will agree that they know I'm doing it because I'm bugging them. I don't know why they're doing it. I don't know what that ideology is.
▶ 1:13:31Now, to enforce the new orthodoxy, there are now over 20 political appointees at the nih. So I want to ask you, Mr. ursell, without political comment or anything, do you support full funding of the national cancer institute? Yes or no? >> absolutely. >> and, doctor zuckerman, do you support full funding of the national cancer institute? >> yes I do. >> does anybody here oppose funding the national cancer institute? No. Everybody here supports it.
▶ 1:14:00Doctor zuckerman, what do you think that young scientists considering going into government or federally funded academia or thinking right now? >> well, I know from experience, because we hire people with doctorates that in in recent months, uh, positions that would normally get about 20 applicants were getting more than 100 in a couple of days.
▶ 1:14:25And that's and many of these were people leaving the federal government or people who would have applied for jobs in the federal government who don't want that insecurity and are concerned about, um, knowing how things are understaffed and hearing about things being politicized. >> thank you. Thank you, I yield back thank you. Member yields back. And I'll now recognize the. >> chairman of the full committee, representative guthrie, for his five minutes of questions.
▶ 1:14:55>> thanks. And thanks again for y'all being here. So doctor brinton, in august of 2024, cms finalized the transitional coverage for emerging technologies, or set, uh, the pathway, which would provide up to five fda breakthrough devices. Um, can you speak to edward? Life sciences experience with pathway. >> yeah. Thank you for the question. Uh, we were in the pilot program for the, uh, for t set for our, uh, our evoke tricuspid replacement therapy.
▶ 1:15:23This was a working relationship between cms and, uh, and edward's life sciences. As I mentioned previously, we started in parallel review for this product in 2020, but at the time we were approaching fda authorization, the process for t set was coming about.
▶ 1:15:36And so we entered what would be described as a pilot program in that the dialog between cms was very active, was a collaborative process to establish any gaps of information, any gaps in data that may need to be filled, basically to ultimately meet the sed requirement of which t set is a requirement leading to an ncd. And so this was a very, I think, very effective process. There was transparency.
▶ 1:16:01Um, we did say it was a 13 month process from the time of authorization to ultimately a time of coverage, but overall a very productive process. I think it is a very good start to answering fundamentally what we need for coverage. >> it was kind of a follow up. Do you think that that the pathway alone is sufficient, or do you think there's other things congress or the administration should do? >> I think we would support very much a broader approach, that there are things that are appropriate. We primarily, for. >> example, a couple of things, a couple of things you think we should do. >> absolutely.
▶ 1:16:30I think ultimately we need, uh, a benefit. You know, it should be a benefit category for coverage. We think it should be a look back period of two years. We think that medicare advantage coverage is essential for this. This has been a significant problem for our experience with evoke. Prior to an ncd, we did not see every excuse for medicare advantage to actually cover this. And ultimately, with the national coverage decision, that's been significantly different. >> all right. Thanks. So I'm also interested in the 401 k submission process for fda review of devices.
▶ 1:16:57Um, could you just kind of walk us through, um, the 401 k process and what fda's role is during the process? >> are you referring to 510 k. >> 510 k? I said 501 k, didn't I? No. No problem. 510 k. Yeah. >> yeah. >> so I'm dyslexic so I'm sorry. >> so the 510 k process is a is a rigorous process. Uh, it's a risk based approach. And yes, it is based on a predicate. And that predicate though means it's been established for a long period of time.
▶ 1:17:25I think the most important essential is that there is ongoing monitoring devices of 510 k. In fact, we have some 510 k products. And we are constantly in dialog with the fda because there is ongoing monitoring for any events. And in fact, the fda has the authorization to request valid scientific evidence or further evidence, or to take action if there is a problem with a 510 k. So it is a rigorous process that often requires the submission of detailed data, detailed biocompatibility data, electromagnetic data.
▶ 1:17:51And in fact, two thirds of 510 k's are submitted that were breakthrough, in fact, included clinical data and data from patients supported. But it was often in augmenting what was originally in the predicate device. >> okay. And so the fda can continue to engage with you as you does the engagement end. Once fda makes the determination of devices as legally marketed, or does fda continue? >> no, absolutely. It continues. It continues on an ongoing process basis. And there is, as I said, an auditing and monitoring process that is ongoing. >> okay. Thank you.
▶ 1:18:21And thank you for walking us through the 510 process that gets important to today's legislation. Uh, so, Mr. izzo, your testimony speaks to the potential of multi-cancer early detection tests to improve cancer care. Do you believe legislation for medicare coverage of these screenings will help encourage more research in this space? I hope there'll be more use of it, but also more research in it as well.
▶ 1:18:43>> I certainly do, and I do so because that's been borne out by past experience, uh, both when congress, uh, elected to provide breast and colon, uh, medicare coverage pathways, uh, that led to an explosion of innovation in both of those fields, um, especially for colon cancer testing. So, uh, this creates a pathway, uh, that provides a signal to the industry and that I believe will unlock more innovation in this field. >> okay. Thanks.
▶ 1:19:11And there's always another lady who's typically in a blue shirt here. She's. I think she's still fine, but, uh, but she's not here at this time with kim. But she, um, had was pancreatic cancer, and I said, wow. How do you hear tend to. I guess I've been here a little while. I said, how do you keep coming back and forth?
▶ 1:19:31And she said, they asked she had another problem and they accidentally discovered or providentially discovered the pancreatic cancer, treating something else before it had metastasized and moved out of her, out of her pancreas. So we were able to treat it, which most people don't have the opportunity to do. So. And Mr. royce, uh, congratulations. I guess that's I don't know if this is an order, but so happy that it worked for you. And I was also. This is your birthday, so you're getting to celebrate twice here today. But it is important. And that's why this early detection. So. Well, I guess I'm out of time.
▶ 1:20:01That was so, so important because and that's why we're pushing it today. And advocates have been pushing it because if we catch everything early, the outcomes are so much better. So thanks for being here and testifying. >> the gentleman yields back. I now recognize the vice chairman of the subcommittee, miss harshbarger of tennessee, for her five minutes of questioning. >> thank you, Mr. chairman, and I want to shout out to nathan farner from my district, uh, in erwin, tennessee.
▶ 1:20:28He is a volunteer advocate for the american cancer society, um, action network. So thanks for being here, nathan. Uh, wave at us. Yeah. Okay. Thanks, pal. Um, doctor brenton, uh, recent report from gao highlighted inefficiencies in cms and the kdd process that led to delays in issuing final coverage determinations.
▶ 1:20:53And the gao recommends the administrator take action to avoid delays in coverage analysis. Does edwards have any recommendations on how the agency can improve the ncd process, enabling timely access to these technologies? >> yeah. Thank you very much for the question. Uh, absolutely. I think that what what we want an ncd process is predictability, consistency, not not necessarily knowing the outcome, predictability of the process.
▶ 1:21:19And ultimately we think that there is a process now, particularly when it comes to reconsideration, where in fact there is still a long process. There's two periods of time would actually go out for comment. So what what is known basically as the um, as a comment, first comment period, basically is a long period in which societies can weigh in. When you're in reconsideration, you already know what the decision should be made. The question should be go out for a single comment as opposed to dual comment.
▶ 1:21:44This has the opportunity to really shorten the time period for consideration of of really life saving therapies such as tavr is a good example, and in fact, tavr is one of those therapies, basically provides very cost effective benefit. And in fact, currently right now, there is a number of patients who do not have access to tavr because of the antiquated requirements that are based on volume. We now have quality standards. And in fact, there's an opportunity to basically modify this. In fact, there's even a bigger reason to modify that.
▶ 1:22:08And that is there's new recent data that suggests in the new england journal that asymptomatic patients actually benefit from actually early treatment, meaning that the current national coverage decision actually only covers symptomatic patients. It turns out that treating asymptomatic patients early has a benefit for those patients. Those patients actually do better. There's not a consequence. In fact, the rate of stroke is lower when they're treated early and it's more cost effective. Yet the current national coverage decision does not cover asymptomatic.
▶ 1:22:34So we now have a reason to address possibly this national coverage consideration. And this should be an opportunity for us to actually evaluate these other antiquated kind of policies based on volume requirements. >> what what's the comment period? What's the frame time frame. How many days. >> so it's it's initially the comment period is 30 days, but it's six months to then respond. Then it's additional three months ultimately. So we're talking about a very, very long period of time.
▶ 1:22:58We can short that because ultimately, in reconsideration, we're already familiar with the technology, already familiar with the benefit to patients that we already have the outcome. >> I'm familiar with the open comment period when they're they're looking at drug therapies and things and device. It's a long process and we need to shorten that. And we met with the fda commissioner this morning in our doctor's caucus. So there's there's happy things coming our way with uh, coverage determinations.
▶ 1:23:21Um, you highlighted that nearly half of medicare beneficiaries, uh, suffer from at least one cardiovascular condition. And I guess my question is, how should medicare prioritize coverage pathways for therapies that address these high burden diseases? >> as I said, this is obviously a huge number of medicare beneficiaries suffer from cardiovascular disorders. Yeah.
▶ 1:23:43Um, ultimately, uh, as we mentioned before, transitional coverage set as we exist today provides an opportunity, but it's limited basically to five, five technologies. And so this is a pace that requires speed to get to a national coverage decision. But there's an opportunity for a lot more than that to broaden the capability. There are technologies that we need to have available to seniors. And so the opportunity to do that basically provides accelerating this process. Yeah.
▶ 1:24:10>> um, enforcement mechanisms you mentioned to ensure that these ma plans provide consistent coverage. Uh, can you elaborate on the gaps you've seen in these ma plans? Um, on breakthrough technologies? >> yes. So, uh, under national coverage decision prior to, I should say prior to national coverage decision, ma plans do not typically cover some of these therapies, breakthrough therapies that are available to seniors. And so a national coverage decision creates the opportunity basically to provide these therapies ultimately to all patients.
▶ 1:24:39We found our own experience when we launched a voc that ma plans made every excuse they could to delay coverage or put coverage off. And ultimately, we see a significant difference with the national coverage decision that it provides, the therapy that those who need it directly. >> okay. All right. Well, I don't have enough time for another question, but I've got lots of questions for you all. So I'll put them in writing and I yield back, Mr. chairman. >> gentlelady yields back. Now, recognize the gentleman from california, doctor ruiz? >> thank you, Mr. chairman.
▶ 1:25:07You know, we know that catching cancer at an early stage leads to better patient outcomes. We know that it's been studied, and it's a common knowledge in clinical practice, uh, because timing is of the essence. And we heard Mr. royce's story. We heard.
▶ 1:25:33And I can tell you numerous stories of patients that I've taken care of in the emergency department of individuals coming in, and you see something a little awkward. We do a test, we refer them, we catch it early, we remove the tumor, the cancer, we start treatment, etc. They live longer and we save their lives. Okay?
▶ 1:25:54We know that, uh, and as a physician, I've witnessed firsthand the positive impact that early detection of disease has on patient outcomes and the fatal consequences that can arise when a diagnosis comes too late, like the farm worker from mecca in my district who hadn't seen a doctor in four years but complained of hematuria, blood in the urine and lower back pain, couldn't afford it. Couldn't see.
▶ 1:26:21A doctor waited four years with an elderly man and guess what the concern was a tumor. Renal cancer metastasized to the lumbar spine. Okay, imagine if the very first signs of blood and urine we could have detected this. Or imagine if he had routine care at his local clinic, and he had a blood test that could detect that cancer and act quickly. Okay.
▶ 1:26:50And there have been promising technological advances in early detection, but more work needs to be done so patients can access these tests. And that is why I'm an original co-sponsor of h.r.
▶ 1:27:06842, the nancy gardner sewell medicare multi-cancer early detection screening coverage act, which would give medicare the authority to cover blood based multi-cancer early detection tests, including future test methods once they are approved by the fda. And this bipartisan bill would improve access to multi-cancer early detection tests for our nation's seniors.
▶ 1:27:30So, doctor brinton, can you talk briefly about why access to early detection and innovative treatment could help to reduce the burden of cancer for some of our most vulnerable individuals or seniors? >> so edwards life sciences is a structural heart disease company. I'm an interventional cardiologist. Uh, so, uh, that's that's my area of expertise in general.
▶ 1:27:51Obviously, anything that directs early identification, uh, as a physician for a disease to get early is obviously a benefit to that patient. So we fully support that. >> um, would, uh, investing in innovative technologies, uh, the life sciences help develop new technologies like this? >> yeah, absolutely. I think that the incentive of a predictable process, basically. Yeah.
▶ 1:28:20Um, both on the fda side, on the medicare side. >> what would. >> drive innovation? >> so what would happen if we cut funding for research on the life sciences and disease study and, and technologies? What would happen? >> uh, which would research? Are we talking about. >> any research like, like life sciences, biotechnology? What would happen? It would slow down research and development. >> it it would. >> it would hamper. >> for edwards life sciences.
▶ 1:28:50We we reinvest 17% of our revenue in r&d so we can fund trials, development and r&d. And obviously for the individual patient, it's a benefit to obviously have research. >> so we can't we you know, so doctor zuckerman, in your opinion, what policies does congress need to pursue to a improve innovation and increase number of new innovative medical technologies available? And b, make sure folks can access these technologies? >> of. Well, of course. And thank you for that question.
▶ 1:29:19Of course, it's really important to have the experienced scientists on staff in the federal government. Uh, it's a big loss when people who are experienced and knowledgeable, they know how the system works, but they also have the. >> like all the firing and cuts that are happening in nih and cdc and all the other. >> so. So that's a big so to the extent we can get new, um, staff, that's obviously new scientists, that's very important, but they're not going to have that expertise.
▶ 1:29:50>> I just want to make one last point is that I support this bill. This test is going to move forward. It's going to become law. I have strong faith. But let's not be fooled here. We took ten giant steps back with all the cuts in cancer research, in all the cuts in the nih, and firings of individuals that's doing precisely the research and development that we need to develop tests like these ten giant steps back with only one
▶ 1:30:20Tiny step forward. Thank you, I yield back. >> gentleman yields back. I now recognize the gentleman from florida, Mr. bilirakis, for five minutes. >> thank you, Mr. chairman. I appreciate very much I want to thank the the witnesses here today as well. These are critical, uh, medicare bills. Uh, I'd like to discuss two priority bills.
▶ 1:30:42The ensuring patient access to critical breakthrough products act and the expanding access to diabetes self-management training act. Diabetes self-management training, as you know, is a proven tool teaching medicare patients on how to manage their glucose and insulin levels and generally improve general care for diabetes.
▶ 1:31:06Uh, I'll call is associated with a risk, a reduction in risk for diabetes related death and heart attack, and, importantly, leads to improved self-care behavior and wellness, which greatly reduces hospital care costs. I look forward to working with the committee on this particular piece of legislation on both sides of the aisle.
▶ 1:31:28The breakthrough bill would help ensure that medicare patients have prompt access to the newest and most innovative medical devices and diagnostics that have been approved under fda breakthrough device. The program nearly a decade has passed since the energy and commerce committee established this program, and during this time, the average time from fda approval to medicare coverage has been six years. Six years is far too long, in my opinion.
▶ 1:32:00Uh, far too long for seniors to wait for a new breakthrough medical technologies. So it is crucial this committee takes action right away. And I know we will. Uh, question number one is for Mr. ezzo. I hope I pronounced that right. Your testimony, uh, discusses the importance of policies that promote, uh, device and tech diagnostic innovation here in the united states.
▶ 1:32:23Can you elaborate further on how the breakthrough device bill would preserve us competitive competitiveness? So very important. Please. >> well, congressman, we believe that the ensuring patient access to critical breakthrough products act would help ensure prompt coverage of breakthrough devices on medicare, addressing a long standing barrier in the healthcare innovation system.
▶ 1:32:52That being the delay between fda approval and medicare coverage. Um, such regulatory and reimbursement lags weaken the incentives for firms to invest in high risk, high cost devices, and even successful fda approval may not translate into timely patient access and revenue. If there can't be coverage, uh, extended via the, uh, the cms, I think, you know, it's also important to put this in a global context. Uh, medical devices were an industry that the united states long led in.
▶ 1:33:17Unfortunately, um, the medical device industry, kind of like the pharmaceutical industry, is sometimes viewed as like the giving tree in shel silverstein's terms. Um, when we had the aca, we imposed a 2.3% medical device tax on the industry. When we look at subject matter eligibility in that field, we find that european and chinese patent offices, uh, extend far more patents to medical devices and diagnostics. And now we have this valley of death between fda approval and, uh, cms coverage.
▶ 1:33:44Um, we've seen global market share of this industry fall for the united states. We've even seen the us trade balance globally in medical devices turn negative. So I think what this legislation contemplates is supports the competitiveness of this industry and its ability to bring more products forward for american citizens and seniors. >> well, thank you very much. Next question is for doctor brenton. Uh, we spent a lot of time discussing what products should be eligible for this transitional pathway and what that means for patients.
▶ 1:34:13Could you also can you also help us understand the types of ongoing evidence, development or real world analysis? Manufacturers already do on products once on the market? >> yeah. Thank you for the question. Um, this is from our own experience with the set pilot. Uh, we did, uh, seek went through a bid process leading to an ncd. It was a collaborative process with cms. We actually identified some gaps in information that needed to be answered.
▶ 1:34:42Um, this period of time, this funding period of time basically provides the opportunity to get the data basically to reach the reasonable and necessary standard in the medicare population and then provides access to those medicare beneficiaries so they can actually access to the technology. So as far as improvements to the system, we think what's what's happened with t said has been a very successful first step. But there's an opportunity to to do more that currently only limits to five technologies.
▶ 1:35:09And we see more technologies coming to market that are beneficial to would be beneficial to, to seniors. The opportunity to expand this program and actually provide more programs that would actually accelerate coverage in the same way, um, and not limit the necessarily to to five technologies per year, because innovation comes and goes. And so you may see a point in time. There's a number of technologies that come along at the same time. And the fact that we have an arbitrary number of five seems actually doesn't serve the benefit of seniors. >> very good. Thank you, I appreciate it.
▶ 1:35:38And I yield back Mr. >> gentleman yields back. Now recognize the ranking member of the full committee, Mr. pallone, for his five minutes of questions. >> thank you. Um, I have some questions about two of the bills that are under discussion today. First, I have a question about the ensuring patient access to critical breakthrough products act.
▶ 1:35:56I'm concerned that the bill we're discussing today would undermine medicare standards for determining coverage of medical devices, and will hamper cms's ability to prioritize the health and safety of medicare beneficiaries. So let me ask Mr. lipschutz, can you briefly discuss the importance?
▶ 1:36:12And briefly, because I got a bunch of questions, the importance of breakthrough devices being subject to cms's coverage process, and why it's necessary for cms to be able to make a reasonable and necessary determination. >> thank you, Mr. chairman. Ranking member pallone, as doctor zuckerman testified, the fda evidentiary standards for devices is generally less than that for prescription drugs.
▶ 1:36:40And when it comes to breakthrough devices, lesser still recent research, including from jama internal medicine, has raised questions about some of the shortcomings in the evidence. Uh, supported for the breakthrough devices and some that have even come to market without clinical testing through the medically reasonable, unnecessary analysis that cms performs.
▶ 1:37:03There is a more deliberative process that looks at the actual medicare population, people 65 and over, including under 65 with disabilities, and stepping back. Medical reasonableness and necessity is really the the guide stone for medicare coverage, and it serves as both a beneficiary protection and a protection for the program itself. >> all right. Well, thank you.
▶ 1:37:27I'm obviously concerned that the bill ties the hands of cms from being able to protect the health and safety of medicare beneficiaries and undermines the agency's authority to maintain appropriate safeguards. And the office of inspector general has also expressed concerns that the legislation poses risks of fraud and abuse, and without medical devices being subject to this reasonable and necessary standard, it will be more difficult for the oig to investigate and enforce against fraud. Um, but let me turn to h.r. 842.
▶ 1:37:55We all support better screening and detection of cancer, and I hope these tests under development will provide reliable options for clinicians and patients. However, there are currently no tests approved by the fda, and clinical trial data are very limited. And due to the novelty of this detection system, many questions are yet to be answered, including whether these tests can accurately detect cancers early, which is why the clinical trials, uh, are so critical.
▶ 1:38:21Uh, I want to make sure these tests are accurately detecting cancer, as both false positives and false negatives can have consequences for for cancer patients. So let me ask doctor zuckerman, as a cancer survivor yourself, can you describe what this committee why false positives and false negatives are so detrimental to patients health, and why it's so important for us to get coverage of this new technology, right, if you will. >> thank you so much for that question.
▶ 1:38:49Um, I can just tell my own story as a cancer survivor. Um, but over a period of ten years before I was diagnosed, I had, uh, a series of abnormal mammograms. Many women have had that experience. And these are all false positives. That's part of the the deal. We know that about mammograms.
▶ 1:39:11But after having some surgical procedures because of those false positives and and then finding out I didn't have cancer over a period of ten years, um, I got, let's say, sloppy about having mammograms as regularly because what was the point of always having abnormal results that didn't mean anything.
▶ 1:39:31And as a result, I was diagnosed a little bit later than I would have been had I not had all those years of false positives with false negatives. It's a different situation. And the problem is that when people are told you're fine, you don't have cancer, then even when they start having symptoms or signs that would normally worry them, it doesn't worry them because they have already been told that they they tested negative on on test.
▶ 1:40:01So that's why it's so important not just for for my experience, many other people have had similar experiences. >> let me just go back to Mr. lipschutz really briefly. Can you discuss the importance of applying medicare benefits equally across the entire medicare population in 20s or less? >> sure.
▶ 1:40:25So the the the cancer detection screening bill would limit coverage starting at three years from now to people 68 and over. Another way of looking at that is that no one today who is over 65 will ever be eligible for coverage under this bill. Medicare is a promise to people 65 and over, not a promise to people who happen to turn 65 at a certain point in time. >> thank you. Thank you, Mr. chairman. >> gentleman yields back. Now recognize the gentleman from georgia, Mr. carter? >> thank you, Mr. chairman.
▶ 1:40:55And thank all of you for being here. This is extremely important. We appreciate your expertise in this and your experiences as well. So thank you, ladies and gentlemen, as both a pharmacist and a member of congress, I know firsthand how timely access to health care treatment is critical and prevention is the key. I often say that regardless of what party you belong to, we all want the same thing. We want accessible, affordable, quality health care. And I think that's true. We do.
▶ 1:41:23But the difference between an early and a late stage cancer detection often means the difference between life and death. We all recognize that. That's why we we go and we have these tests, and that's why we encourage these tests. The medicare multi-cancer early detection screening coverage act gives us the opportunity to prevent late stage diagnosis and rewrite the cancer narrative by allowing for multi-cancer early detection tests to be covered in medicare in a timely manner. And I think that's extremely important for us.
▶ 1:41:53Late, late stage cancer is not only the deadliest, but it's also physically and emotionally devastating for patients and for caregivers. Let's don't forget about that as well. Thankfully, we have the technology to detect cancer earlier, but we must ensure seniors can can access it. So that's why the medicare multi-cancer early detection screening coverage act is a win. It's a win for patients. It's a win for families. It's a win for sale medical practice. And it deserves our immediate passage.
▶ 1:42:21And I encourage my colleagues on this subcommittee on and the full committee to pass this. Miss royce, I want to ask you, um, and I'll ask Mr. zell as well. But, um, you first, Mr. royce, could you discuss the potential medicare savings, savings from covering multi-cancer early detection tests under this bill? >> yeah, that's probably not really my area of expertise. I think I'll defer to Mr. >> okay. Mr.
▶ 1:42:54>> well, um, congressman, as I noted in my testimony, it's estimated that at current rates, medicare will spend $1 trillion on cancer care over the next decade. Uh, estimates currently. Um, hold that, uh, about 33% of america's cancer care cost is borne by medicare. That may be as high as 50% now. So the challenge of cancer already brings enormous cost to the system.
▶ 1:43:21So if we can catch cancers earlier as opposed to later stages when it's far more economical to treat them, then we can put america's response to the cancer challenge on a more stable economic footing. I'd also add that, uh, past experience here can be illustrative, as I understand, uh, when congress passed laws in 1990 and 1997 that scored $5 billion to enable coverage for mammograms and prostate and colorectal screenings.
▶ 1:43:48But according to a study from the university of michigan, americans have gained at least 12 million more years of life and at least 6.5 trillion additional dollars of economic impact because of preventive screenings over the past 25 years. >> and those are really things you can't put a price on. I mean, let's face it, that that's invaluable. I mean, well, thank you for that.
▶ 1:44:09Um, I also want to speak in support of the encouraging patient access to critical breakthrough products act, because this bill will help us ensure that seniors and other medicare patients have access to the newest and the most innovative medical devices and diagnostics that have been approved through the fda. You know, earlier this morning, we have, uh, we have a doctor's caucus here in congress. And earlier this morning, we heard from doctor markey and, um, with the fda, and they were and he was really telling us they're trying to speed up the process. And I'm really encouraged by that.
▶ 1:44:38I hope that that's something that that they're able to achieve. And I think it will be. But I'm particularly excited about the cutting edge diagnostics currently in the fda breakthrough devices program, such as tests to support earlier alzheimer's disease diagnosis. You know, alzheimer's is is going to cost us so much money in the future. Not only that, but also just the physical toll it obviously takes on the patient, but on the caregivers as well. All that needs to be taken into consideration.
▶ 1:45:08You know, I served ten years in the georgia state legislature on health and human services, and I've been here for ten years. It's always difficult for me to to articulate that to my colleagues who aren't in health care. The value of well care, the value of of prevention and making sure and the savings of it, how much money we could save through doing that.
▶ 1:45:28So let me ask you, doctor, um, brenton, would you agree that there needs to be accelerated, um, medicare coverage pathways to ensure that our seniors have timely access to diagnostic and medical device innovations? >> I think currently, as as the bill put down, this is for breakthrough technologies and breakthrough technologies determined by the fda. I think reminding everybody that these are these are technologies that actually have been, uh, authorized. So of the large number, you know, 1176 devices are breakthrough.
▶ 1:45:58Only 160 have ultimately become authorized. So we're talking about those, which includes diagnostics. And yes, I think access to these technologies that are appropriate gives time basically to gather more data rd necessary. >> great. Well, this is extremely important. Thank all of you for being here and for your testimony. And I yield back. >> gentleman yields back. Now recognize the gentlelady from washington, doctor schrier. >> thank you, Mr. chairman. Thank you to our witnesses today.
▶ 1:46:27Uh, I'm going to talk about a few things. One is just that I'm very excited that my bill, the expanding access to diabetes self-management, the bill I have with Mr. bilirakis is up for discussion today. I know how important it is. I'm a pediatrician. I also have type one diabetes. I remember all of my training. I want everybody with type one. Type two. This is specifically type two to have this kind of training to have their best possible outcomes. Uh, and anyway, thank you everybody for voting for it.
▶ 1:46:58Um, doctor zuckerman, I am going to turn now to the multi-cancer early detection topic. Um, and I'd like to dive in a little deeper. Of course, our goal is early detection. Early treatment. I mean, that is our north star. Um, these tests, and at this point have pretty low accuracy and can lead down a path. Um, I, Mr.
▶ 1:47:30Griffith, representative chair. Sorry, chairman griffith really focused in on false negatives and the risk there of false reassurance. Um, I was going to dive in a little bit to false positives. I was taught in medical school. Don't do a test if you don't have a plan for something to do with those results. Um, it's a very smart thing to consider. Um, so I was wondering if you could just touch briefly on, let's say you get a positive test.
▶ 1:47:56We know there's like a 17%, uh, sensitivity for early stage cancers. You don't know what part of the body this is from. So what do you do next? >> well, thank you for that question. Um, obviously, there's a lot of differences of how people react to that. Some people might be told, oh, probably it's nothing.
▶ 1:48:22And they don't really want to know that it is something so they won't do anything. But a lot of people will follow up. And that cascade of testing is something that I've experienced personally, and I wouldn't wish it on anybody when it when there's nothing really happening. Uh, also, you can get a scan for one part of your body and then they, they notice some little abnormality in a different part of your body.
▶ 1:48:50Then you have to have a biopsy or something else in that other part of your body. It ends up to be nothing. So that's right. The more often that happens, not only it costs a lot for the patient, but it's also so, you know, you know, you're relieved. But also. >> that's that's sort of the point is that it can take you down quite a tunnel.
▶ 1:49:10I mean, there was a time when people wanted to get full body ct scans just to check, and they found what we call incidentalomas, just all these little incidental nothing findings. And then you go down those paths and it ends up costing a lot of money, usually finds nothing. And so with the perfect intention, it ends up, um, just not not really performing as we would hope. So I just want to say that with all the oncologists that I spoke with, they don't think these tests at this point are ready for prime time.
▶ 1:49:39But I do want to talk about what we can do for cancer and for early detection. I mean, the first thing, let's restore some nih funding to support this kind of research into early detection tests. So let me make that point once again, that this administration cut nih funding and they're looking to do it again. Uh, I also want to talk about the us preventive services task force. It's a mouthful. Uh, rfk jr is looking to cut this.
▶ 1:50:07This is what makes sure that insurance covers screening tests like colonoscopy and mammograms and skin cancer screenings. Of course, you have to have a primary care physician, so you have to have medicaid for that. And they're cutting that to, uh, the us preventive task force. It also talks about pap smears to find, uh, cervical cancer early. And they're looking to cut that. I just want to point this all out. Then there's also prevention. Right. Sunblock.
▶ 1:50:36We're looking to get more research into sunblock smoking not mentioned in the make america wealthy again agenda. Uh, hpv vaccine. They're downplaying and they're actually bashing the hpv cervical cancer preventing vaccine. Uh, in the acip and hepatitis b vaccine you think about hepatitis.
▶ 1:50:57But for those babies who get congenital hepatitis b, 90% of them then have, uh, chronic hepatitis b and a quarter of those go on to liver failure and liver cancer. So I just want to talk about the other things we can do at this moment. I have 15 seconds in the advisory committee for immunization immunization practices meeting. They are disparaging hepatitis b and encouraging, uh, not giving that to newborn infants.
▶ 1:51:22We did not see a meaningful decrease in hepatitis b in the community until we did universal vaccination. This is going to put kids at risk. It is going to put the other kids at school. Hepatitis b can live on surfaces for, uh, seven days, go from one kid scratch to another kid scratch. Many times we don't even know where it came from. And this is making the world a more dangerous place, particularly for children.
▶ 1:51:50When we start backing off on vaccination programs. Thank you. I yield back. >> gentlelady yields back. Now, recognize the gentleman from florida, doctor dunn, for his five minutes of questions. >> thank you very much, Mr. chair. And thank you to our witnesses for being here today. As a doctor. I'm proud to be one of the hundreds of supporters for h.r.
▶ 1:52:09842 the nancy gardner sewell multi-cancer early detection screening coverage act in congress, the status quo of cancer detection in america today is plainly unacceptable. Each each day, more than 1400 medicare beneficiaries receive devastating news that they have advanced stage cancers.
▶ 1:52:32Further, over 70% of cancer deaths occur from cancers for which there is no routine screening. Uh, this demands our attention. While practicing, I certainly experienced firsthand the difference between early stage and late stage cancer diagnosis. Simply put, when it's caught early, patient outcomes are dramatically better. H.r 842 offers us a chance to do just that.
▶ 1:53:01Rather than accepting late stage diagnoses as inevitable, we can invest in technologies that detect cancer, which, you know, when treatments are most effective. And, by the way, less expensive. Uh multi-cancer. Early detection would be a game changer in how we approach cancer screening. And these tests can identify dozens of cancer types that are often not detected until symptoms appear.
▶ 1:53:28Our role in congress should be to ensure these innovations are accessible when people need them. Uh h.r 842 enjoys overwhelming bipartisan support because it addresses this unique challenge with an innovative solution. Mr. ezell. Um, cancer places a number of burdens on patients and their families. Can you speak to the need for innovation in cancer screening to help reduce those burdens?
▶ 1:53:57>> well, you've talked about it, sir. Um, and we have today, uh, 40% of americans will receive a cancer diagnosis in their lifetimes. It's the second leading cause of fatalities in america. It killed 600,000 americans a year. It hits elderly populations especially hard, with age being the number one risk factor. Um, so this is a national challenge that we need revolutionary innovation to address. And I believe that's what multi-cancer early detection technologies are poised to do.
▶ 1:54:24Um, certainly there are concerns about overdiagnosis. Um, and it's going to be critical that these multi-cancer early detection systems be optimized to avoid that overdiagnosis and increase our positive predictive value. But I would stand by the words of doctor bart vogelstein, uh, professor of oncology at johns hopkins university, who says america now suffers from a massive underdiagnosis problem.
▶ 1:54:49>> so do our current policies that actually support getting these innovative tools to patients in a timely manner. And if not, do you think? 842 h.r. 842 is an effective way to increase the utilization of these innovations.
▶ 1:55:05>> well, I think the critical point about this legislation is that it simply states, if companies bring these multi-cancer early detection screening tests before the fda and the fda approves them for their safety and efficacy, and then that the cms thinks coverage is appropriate to greenlight after review. Um, and doctors prescribe those tests for patients, then seniors can access them. There is nothing in this legislation we're looking at that puts either the fda or cms ahead of the science or the evidence.
▶ 1:55:33>> so you're in favor, I think, uh, I'm pleased to see the, uh, this committee taking steps to move. 842 through our process, I look forward to continuing to support it. I'm also pleased we're considering legislation to ensure transparency in the national coverage determination and the local coverage determination process and cms. I've done work on this, uh, these issues in the past.
▶ 1:55:58Look forward to continuing to work with my colleagues, uh, on this, uh, as we go forward. It's, uh, it's vital that these coverage decisions are made in a timely manner with appropriate stakeholder input. So once again, Mr. chairman, I want to thank you for, uh, for holding this important hearing, and I yield back. >> I appreciate the gentleman yielding back. And now recognize Mr. vc for his five minutes of questions.
▶ 1:56:28>> thank you, Mr. chairman. Um, and I want to be clear, republicans on this committee have completely walked away from their responsibility to provide oversight. Um, they have let this secretary of health and human services run unchecked. Um, our health care system is being undermined right now in front of us. And american leadership and medical innovation, I believe, is on the line. Uh, the secretary has proposed cutting nih funding by nearly half, and that would drag us back to 2007 levels.
▶ 1:56:57Uh, he's pulling the rug from under researchers who make cancer breakthroughs possible, who run clinical trials to train the next generation of scientists. And those cuts are going to mean slower progress and higher costs. And more americans dying while waiting for cures that may never come. And these families that are dealing with the prognosis of cancer, they want to see action now. They want resources to be given now. Uh, and that's the real cost of this failed leadership.
▶ 1:57:27And so while I'm glad we're here today to talk about seniors access to medical innovations, including cancer testing, I'm very disappointed that the secretary's at the same time pulling us backwards on cancer research. Again, these families don't want to see us go backwards, and they don't want to see less funding for cancer research. Uh, we can't celebrate innovation with one hand while gutting the very foundation that makes the innovation possible with the other.
▶ 1:57:54Uh, that's why the bills were discussing today matter so much in the district that I represent in the dallas fort worth area. Cancer carries a burden for way too many families, and many of us have had loved ones diagnosed with cancer. Many of us have lost loved ones that had cancer. Uh, and if you've lived through that, you know that you do anything to spare someone else that pain and suffering. And that's why I'm proudly co-sponsoring, uh, h.r.
▶ 1:58:21842, the nancy gardner sule medicare multi-cancer early detection act, uh, and a bill that my dear friend terri sewell from alabama has worked tirelessly to get passed in honor of her of her mother. Uh, and every year, cancer claims more than 600,000 american lives, including 44,000 in texas. And far too often, that's because we find it too late. And multi cancer, uh, early detection tests change that.
▶ 1:58:49They can screen for dozens of cancers that currently have no routine tests, often catching them earlier when they can still be treated. And we've seen the promise of this technology. Dallas cowboys quarterback dak prescott funded screenings for the cowboys staff, and one of those screenings caught communications executive todd carper's neck cancer early cancer that otherwise would have gone undetected until it was too late. And that's the type of innovation that saves lives. And so passing hr 842 isn't just about policy.
▶ 1:59:19It's about doing right by patients, families and communities. It's about making sure that life saving innovation reaches people no matter their age, income or insurance status. Uh, but here's the challenge. With any new technology, we absolutely have to strike the right balance. We need to make sure products are safe, effective, and we also have to make sure that americans don't have to wait years on end for access to the innovations that can save their lives. And so with that, Mr.
▶ 1:59:49Zell, I have a question for you. You've talked about how transformative this, uh, mst technologies could be. How does h.r. 842 uh, the nancy gardner sewell medicare multi-cancer early detection act strike the balance between protecting patients through rigorous standards and ensuring they can benefit quickly from life saving innovation. >> thank you for the question, congressman.
▶ 2:00:16If I could start actually, by addressing the first part of your remarks, um, since 1990, every $4.2 million of federal funding for our for research and development has led to one invention disclosure from a us university. There's a direct connection between federal r&d funding and innovation in the united states. And if the budget proposed at the start of this year would actually come to pass, the united states would fall to third in the world, behind china and the european union in funding of r&d.
▶ 2:00:44Right now, america is 34th among oecd countries in federal government funding of university research. This is not the company that the united states should be in. We should be leading the world, and we absolutely agree that we have to continue to fund innovation. Detection matters. Uh, one of the nice things about the early cancer detection is it can enable us to identify patient populations like doctor royce's. This can help us identify new biomarkers so companies can go and innovate new drugs.
▶ 2:01:11Um, because we now have populations to innovate against. So this legislation again provides a pathway for coverage. And I think it balances the issues you addressed because it doesn't put us before the science or the evidence. It only says if the fda approves these tests when the science is ready, and the companies won't bring this technology to the fda until they think it's ready. But then if the fda approves them, this gives cms a pathway to extend coverage to seniors. >> thank you. Thank you, Mr.
▶ 2:01:41Chairman. >> gentleman yields back. Now. Recognize Mr. crenshaw for his five minutes of questioning. >> thank you, Mr. chairman. >> and thank you for this incredibly important hearing. Hearing all the time from from innovators that, you know, fda is is its own beast. But but but then there's the valley of death of cms.
▶ 2:02:03And that's very frustrating because there's obviously some duplicative, um, uh, duplicative mission sets between fda effectiveness and cms, uh, role in this. So, you know, medicare needs to be a bridge to innovation, not a barrier. Um, I'm really proud to work with my colleagues on this legislation that puts patients first and ensures seniors aren't left behind. We'll talk about a couple of things. Uh, first, Mr.
▶ 2:02:29Zell, um, on the multi-cancer, uh, early detection. Talk about how that will revolutionize healthcare. And specifically, can you quantify some of the real world impacts for seniors, whether that's in terms of how many we might, how much more we might catch early, how much money we might actually save in the long run. Um, and, and shifting those outcomes from these late stage fatal, uh, uh, conditions to more manageable conditions.
▶ 2:03:07Truly, you do have numbers because you're looking for them. So I'm excited to. >> have numbers. Um. So just, uh, speaking to the importance of cancer prevention and screening, um, it's estimated that from 1975 to 2020, um, cancer prevention and screening efforts averted an estimated 4.75 million deaths from breast, cervical, colorectal, lung and prostate cancer. Um, so we know that screening saves lives.
▶ 2:03:35And we know now that, uh, the the ability of this multi-cancer early detection technology to potentially detect a far larger range of cancers than the five we currently have screening tests for, um, will enable us to catch more cancers and catch them earlier, when the evidence shows clearly that survival rates, uh, on average across the whole population, um, are two times higher for non static
▶ 2:04:05Versus metastatic cancer. So I don't know the particular numbers for the medicare age population. Uh, but I know that this technology is positioned to save lives. >> yeah. Uh, and, Mr. royce, any of this firsthand, uh, I'm sure you'd agree, uh, with with that and the impact on families. >> um, yeah, absolutely. And for example, in my case, it's a difference between a 13% five year survival rate and a 44% five year survival rate.
▶ 2:04:32Just just going from stage two to stage four. And, um, and much more than that. And, you know, if you don't mind, I, it's really odd for me to sit here and listen to people talk about me like I'm a statistic instead of a person.
▶ 2:04:48When we talk about false false positives and we already have the ultimate false negative system here. We have doctors guided year after year. When I go in for a physical, I'd say nothing's wrong.
▶ 2:05:19Nothing's wrong with you. We didn't screen for cancer, but we don't see anything wrong with you. That's the ultimate false negative. So sorry for that diversion
▶ 2:08:52Doctor brinton. Brinton, uh, can you. >> yes. >> with the insurance companies they are regulating. >> that would be ideal. So would it concern you to know that the individual who ran those health care for the first hundred days of this administration, uh, Mr. brad smith, that he simultaneously had a private company whose five biggest investors were all the health insurance corporations that are regulated, reimbursed by medicare advantage. Would that be a conflict of interest? >> it appears that it would be.
▶ 2:09:21>> do you think that from that conflict of interest, this individual running cms under for doge invested in by medicare advantage health insurance corporations, do you think the american public should be concerned that those medicare advantage health insurance corporations then got regulation cuts and reimbursement increases under his tenure, would that be concerning? >> I think it raises a lot of red flags. >> oh, lasers, a lot of red flags.
▶ 2:09:48That would be terrific if the committee of jurisdiction might want to ask about, particularly since this individual, Mr. brad smith, is now going into the state department to run global health for our country. Lord knows how he's going to make money doing that, but I'm sure he'll find a way. Uh, Mr. ezell, you have made your career as an expert in biomedical innovation, and particularly the foreign policy dimensions of biomedical innovation. Is that correct? >> yes, sir.
▶ 2:10:12>> in the last two years, uh, in, excuse me, in the last six months, do you think china has relatively advanced or relatively receded relative to the united states in biomedical innovation? >> sir, for the first time last year, chinese applicants filed as many initial new drug applications with the fda as us enterprises did. China's share of global biopharmaceutical value has increased fourfold in the last 20 years. China is now a major global competitor. >> is it fair to say that america used to be winning in biotech and biomedical r&d? Yes.
▶ 2:10:43Are we winning right now? >> we're no longer the clear global leaders. No we're not, sir. >> no, the chinese are building multiple kendall squares as we speak. Is it wise to slash the nih budget in half, as the president proposed, in order to compete with the chinese? >> you know what I'll say is that if you roll the tape back to 1990, european headquartered drug companies introduced twice as many drugs as we did over the last 35 years.
▶ 2:11:08We have completely flipped that script because we created a policy environment that supported private sector innovation through things like robust nih investment, r&d, tax returns, etc. We have to maintain the right policy environment. >> so yes or no. Is cutting in half the nih budget a good idea? >> no it's. >> not no, it's not. Uh, is the, uh, chaotic implementation of imported price controls going to help with innovation in the united states? >> we need a stable pricing environment. >> to pay for value. Right?
▶ 2:11:38Not not based on, uh, fear or favor. >> we can import drug price controls. Then we can import what they have, which is no drug innovation. >> I'm going to close with doctor zuckerman. Doctor zuckerman, you've made your career in understanding, um, impact of various medical interventions. Do saunas have a high impact? Uh, are they worthy of, uh, public tax reimbursement for their health benefits, in your opinion? >> um, I'm sorry I missed. >> the saunas. >> I'm sorry. I don't know what that is.
▶ 2:12:09>> saunas. Like the things that you go inside to get hot. >> oh, saunas. Saunas. I'm so, so sorry. Uh, say that again, please. Just the whole question. >> I'm sorry. We're out of time right now, so I'll simply just close with a statement. Sorry. I can ask it for the for the record, but we have an individual advising rfk. Mr. carly means, who runs his own company on the side. True med uh and Mr.
▶ 2:12:35Means has enabled individuals to use their health savings accounts tax preference dollars um, to buy saunas because letting the wealthy buy saunas with tax preference dollars apparently serves us public health. Um, but hepatitis b vaccinations don't. That is the system that we have right now, and that is the system that the majority is allowing to govern without any oversight, I yield back. >> I agree that wouldn't be top of my list. Thank you. >> gentleman. Yields back.
▶ 2:13:05Now recognize the gentleman from pennsylvania doctor joyce for his five minutes of questioning. Thank you, Mr. chairman and ranking. >> member. >> for holding such a critical issue discussion here. >> this morning. >> innovation has long. >> been the cornerstone of. >> american medicine. It's how I practiced medicine for 25 years. America has consistently. >> led the world in development. Of new and. >> innovative therapies. >> and cutting edge. Medical devices.
▶ 2:13:34>> however, due to the current payment structure of medicare, our nation's seniors frequently. >> can be excluded. >> from accessing the newest medical device technology. In fact, this delay in coverage. >> following an. >> fda approval by cms has the unfortunate name of the valley of death. >> doctor brinton. >> as a doctor. >> and as a scientist. >> can you speak to the impact on patient care that many of these breakthrough devices can offer?
▶ 2:14:02And then can you talk briefly about how the delay in coverage can ultimately affect patient outcome? >> no. Thank you for the question. Um, you know, as you mentioned, the valley of death, we think about this, uh, about it for the company itself. So from all the work of trying to solve an unmet clinical need to ultimately what might be a decade of time to get to fda authorization. But the reality is, if you're in the valley of death, there's no no coverage possible to get this to actually the patients that need it the most.
▶ 2:14:31So that valley is quite significant. In fact, I believe josh mcclure did work on this at stanford and know that it's at least five and a half years on average for coverage after an fda authorization. >> our lives lost while people wait that five and a half. >> a huge impact potentially so being able to actually provide access. And I mentioned this earlier, access coverage to for a physician to make a decision with the patient risk versus benefit of that therapy, which has been deemed by the fda to be safe and effective, seems appropriate that that we want to provide that access to these seniors.
▶ 2:15:01>> doctor brinton, we've heard from some that sid is a critical component of access to the innovation that you're talking about right now and from others who actually feel it truly limits all access. Can you talk about the role that you believe sid should play, if any, in cms coverage decisions? >> so I think we're at we're talking about sid done. Right. And so just just to back up, I think there's a significant difference for sid with medical devices than there is for pharmaceuticals.
▶ 2:15:31For instance, you know, the challenge with pharmaceuticals is you open the package and compliance is the biggest challenge with devices. This involves a procedure which means it gets better over time. People have to train and get the experience, and often there's iterations and improvement, the technology. So I think being able to actually provide access, you know, to patients with having sid provides the time basically to provide the evidence that needed to meet the standards, basically of reasonable and necessary. So it's providing that opportunity of time.
▶ 2:16:01>> thank you. Also considered in this hearing is legislation to improve access to multi-cancer early detection testing advancements, which can identify dozens of cancer types through a simple blood test, often before there are any symptoms. This technology enables doctors to intervene when treatment can be most effective and least invasive, dramatically improving prospects. Prospects for successful outcome with the ultimate goal of treating and curing cancer. Mr.
▶ 2:16:31Royce, let me first of all say that you are not a statistic to me as a doctor, I never treated a patient as a statistic. I'm trained in science, I utilize science, I understand how important numbers can be. But you and your testimony here today has been riveting.
▶ 2:16:49Can you speak more on how this testing, specifically early detection, improves outcomes in your case and the discussion that didn't occur with your brother and treatment courses and how that's impacting cancer today? >> well, thank thank you for that, I appreciate it.
▶ 2:17:10Um, well, clearly, as I said, the one thing I had a lot of doctors at oncologists, you know, I had surgeons and radiologists and you talked to three doctors and you get five opinions. Sometimes it seems like. But one thing they all did agree on is that my prognosis would have been much, much worse if I had not had this test. And just to reiterate, reiterate, you know, I did have an annual physical. I thought I was healthy, I was doing everything right.
▶ 2:17:38And every year it's like you have no symptoms. There's nothing you need to do. There's nothing wrong with you. This one little blood test can really make a huge difference. >> did the early detection save your life? >> yes, I believe it did. >> thank you. I look forward to working with all of my colleagues to advance this critical legislation behind what we are considering and discussing in this hearing today. This is a bipartisan issue that we can have significant impact on.
▶ 2:18:08Thank you, Mr. chairman, and I yield. >> thank you. The gentleman yields back now recognizes the gentlelady of illinois, miss kelly, for her five minutes of questions. >> thank you, chair griffith and ranking member. >> degette for holding today's hearing. And thank you to the witnesses. I am very proud to support the bipartisan nancy gardner medicare multi-cancer early detection screening coverage act, h.r. 842, Rep. sewell and arrington lead.
▶ 2:18:33I encourage my colleagues on both sides to join us as we aim to make real progress toward eliminating cancer as we know it. Breakthrough advancements in cancer screening technology has put us at a juncture with those who are at the highest risk of developing cancer. Seniors can have access to technology technologies in a timely manner. The leading early detection tests have false positive rates below 1%.
▶ 2:19:01Cancer affects our families, friends, community and health system in untold ways. As you know, it's no political party or zip code. That's why this bill is the most endorsed healthcare bill in congress. As chair of the congressional black caucus health brain trust, I am dedicated to addressing health disparities and inequities that persist within our health care system.
▶ 2:19:21It is our collective responsibility to dismantle the barriers that hinder access to timely and affordable cancer screening, diagnoses, and treatment. Science, evidence and innovations are all pillars in this bill, giving fda approval, authority and cms full coverage authority to make decisions. Mr. royce, I just want to thank you so much for being here today to share your story.
▶ 2:19:49Pancreatic cancer is one of the deadliest cancers we face. Some of my colleagues, to many, lost their battle against pancreatic cancer. So this is personal to me. Nearly 80% of patients are diagnosed at stage 3 or 4. When surgery is likely no longer an option. Survival rates are in single digits, but your story is different because your cancer was found early.
▶ 2:20:11And how did early detection affect your experience and continuing of care compared with what you were told might have happened if it had been found later? >> yeah, well, as I said, if it had been found later, my prognosis would have been much worse. You know, one thing we had not really drilled down on here is why that is.
▶ 2:20:32And maybe it's because there is a room full of doctors here, and we already know this, but it's worth saying that cancer is a very complex set of diseases, and the longer it goes on, the more it has an opportunity to mutate, to hide, to change, to express different antigens. And that's why the immunotherapy I got, and that we've been all reading about in the papers lately, it works way better when it's caught early, even that, you know, the latest, greatest technology is much less effective later.
▶ 2:21:01So early detection I think is just super important to curing this disease. >> thank you so much for your response. And again, thank you for sharing your story. We need to mark up this bill and move it forward. Now is the time to act and provide our constituents with access to life saving cancer technologies. Lastly, I would be remiss to not bring up the advisory committee on immunization practices.
▶ 2:21:25Acip given today's meeting in 1964, was created and has been charged with protecting america's public health through science. But in june of this year, senator kennedy fired all 17 members of the committee who were vetted scientists with unimpeachable credentials and replace them with anti-vaccine conspiracy theorists who have yet to publicly disclose possible conflicts of interest. The administration justified this purge in the name of transparency.
▶ 2:21:54Yet the only thing transparent is the secretary's commitment to dismantling public health, brick by brick, and jeopardizing the lives of americans across the nation. We cannot let this continue to happen or people will die, I yield back. >> thank you, miss kelly. Um, I recognize myself, uh, from ohio. Uh, thank you all for being here today. My first questions are for, um, Mr.
▶ 2:22:24Bryson, um, thank you for being here today. Can you tell me a little bit more about why breakthrough is the appropriate criteria for innovation eligible for this transitional coverage pathway? >> yeah. Thank you for the question. Uh, obviously, 2016, the 21st century cures act basically started obviously, the breakthrough designation. And since that time, it's obviously been 1176 devices that obviously met that that definition.
▶ 2:22:53And that was a definition made by the fda. Um, the need basically is for more effective treatment or diagnosis of life threatening or irreversible debilitating human diseases and meeting the criteria of being a novel technology or a novel application. Not having any alternative therapy devices offer significant advantages, basically for patients or in the best interest of patients. This is really what we need for our seniors. This obviously is an unmet clinical need that exists within our medicare beneficiary population.
▶ 2:23:22So it absolutely is the right criteria. Now it's not the same to actually meet the breakthrough designation because it requires obviously fda authorization. So now we're down to 160 as opposed to 1176 devices. So a much smaller population that is not met. That threshold basically is safe and effective. That would be eligible for such a coverage policy. >> so breakthrough technologies, does the fda approve? What's that? How many, how many, how many breakthrough technologies does the fda approve.
▶ 2:23:53>> in total? >> yes. >> I'm not familiar with that number. >> all right. Um, my follow up to you, sir, is, uh, many describe cms's approach to coverage of breakthrough technologies as a wait and watch strategy where coverage is delayed while more evidence is gathered, often at the expense of timely patient access. Based on your experience with evoc and tavr, do you believe this approach strikes the right balance between patient safety and access, or is it creating unnecessary harm?
▶ 2:24:24>> so I think that this is a risk, a risk versus benefit. You know, balance, uh, an appropriate balance. It's providing access to a therapy that is really it changes the lives of patients with heart failure, which is what tricuspid regurgitation is. These patients have terrible, debilitating disease where most studies show that they would lose their quality of life over their length of life. And that's what this is addressing.
▶ 2:24:45So yes, I think the partnership we've had with cms and working through gaps potentially in information to meet the criteria of reasonable and necessary and using sed as a way to actually develop that data to actually lead to an ncd is been very productive. >> okay. So I think you just answered my follow up, which would what alternatives would you recommend and any others that you would like to add? >> yeah, I mean, I think that we mentioned earlier in my testimony, I think that this should be under under a specific plan. It needs to be basically a two year look back.
▶ 2:25:15I think that there obviously needs to. Medicare advantage, which has been mentioned here today, needs to be something that's covered. And we support the $10 million of funding to support cms, particularly to be able to support such a pathway. >> thank you. The next question is for Mr. mike ezell. Uh, thank you for being here today. And I'm a longtime supporter of early detection screening. And believe the rule these early detection screenings test have untailored tailoring preventive care and improving treatment outcomes is incredible.
▶ 2:25:41In your testimony, you mentioned that medicare lacks a preventative benefit for multi-cancer early detection mrd test. In your opinion, what are the risks to seniors and to the medicare program itself? If congress does not act to establish a coverage pathway for these tests?
▶ 2:26:02>> well, I think first by congress acting to create a coverage pathway, it will send a signal to the industry, uh, that this is a flourishing field, that there is going to be the potential for breakthrough innovation to be rewarded. It increases the financial incentives to innovate in this industry. Um, so I think it will drive forward the industry. I think it will drive forward the science. And that's positive for innovation, that's positive for seniors.
▶ 2:26:29Um, and then mechanically, you know, it's imperative to emphasize that this legislation does not put congress before the science or the evidence. When the companies think that the technology is ready, then they would bring it to the fda for approval, and if approved, then cms would have the ability at that point in time to make a coverage determination for, um, coverage or not.
▶ 2:26:50But certainly this sends a critical signal to the industry, um, just as it did before with colon cancer, um, that this is a ripe field for innovation. >> okay. Thank you very much. And I will yield back my. >> remaining time. The gentleman yield real quick for informational. Yes, ma'am. Um, I, larry, congressman, former congressman bouchon and I worked on cures 2.1, and we have it, um, in the hopper getting ready to go.
▶ 2:27:15We're working with your side of the aisle on it, and it addresses a lot of the cms issues on on approval and funding that you guys were talking about. So I look forward to working with you on that. >> thank you. Representative. Next up, uh, is representative fletcher. Um, from the gentlelady from texas. >> well, thank you, Mr. chairman.
▶ 2:27:41Um, and thank you, ranking member degette, for holding this hearing today and for bringing forward for consideration these bills. And thank you to all of our witnesses for your testimony. >> I share the concerns that many of my colleagues have already raised about the republicans failure to extend the advance premium tax credits, failure to lower costs, and instead drive them up through these disastrous cuts to medicaid and others, and failure to conduct oversight of the firings at cdc. The newly appointed acip, conflicts of interest, and so much more at our country's health agency.
▶ 2:28:11So today is a bright spot in the hope that congress can do its work, rather than cede its authority and its responsibilities to the white house, as it has happened time and again this year. Uh, so this hearing is good and it's important, but we can't talk about breakthrough medical devices without also examining the cuts to the research that led to these breakthroughs.
▶ 2:28:34Since taking office, president trump and his administration, as you all know, have worked systematically to dismantle scientific and medical research across the united states. And my friends on the other side of the aisle really haven't said a word about it. But the people I represent have many of them work at the texas medical center in houston, which is the largest medical center in the world and home to some of the greatest minds in medical research and the most advanced and incredible care. The medical center.
▶ 2:29:02The texas medical center employs more than 100,000 people. It has 10 million patient encounters a year and gdp of $25 billion. And I have heard from people and institutions across the tmc and across my district that the impact of these funding cuts that they are having on critical research that's being conducted there and across the country already, baylor college of medicine has laid off more than 100 employees because of expected reductions in federal funding.
▶ 2:29:29Ut health in houston has also laid off staff and put in place a hiring freeze. And in the last nine months, we all know the trump administration has canceled at least 1.8 billion in nih grants. It's also cutting other funds. As we all know, I could spend five minutes talking about that.
▶ 2:29:44But instead, I want to ask you, because in your testimony about multi-cancer early detection screening tests, you talk about how china is prioritizing the development of these tests to expand its leadership in biotech while we are defunding it. And as you've probably seen, there's been a huge drop in applications for postdoctoral positions in the united states from europe and china. The scientists that did study here are now leaving to take new positions that are being created in other countries.
▶ 2:30:11In a poll of more than 1200 scientists, three quarters of the respondents said that they are considering leaving the united states because of the trump administration's actions around research. So do you think that cuts to research in the united states and the brain drain that it's causing helps or hurts our ability to create and bring new breakthrough devices to the market?
▶ 2:30:37>> well, that cuts to nih funding will certainly compromise america's ability to be a leader in the biopharmaceutical field in the future. You know, we're already seeing countries like france put in place specific programs to in singapore as well to attract us researchers who have their funding cut here in the united states. Um, so countries are putting in place strategies to take advantage of this opportunity. Now, with regard to said, uh, china has made it a national priority. Actually, uh, they've already implemented the coverage pathways we talked about.
▶ 2:31:05And in fact, china is reimbursing their companies for their research cost. If they are able to show it leads to effective screening test. Um, and, you know, more broadly, uh, one of the great potentials, as we've talked about is msd's ability to help us identify rare cancers, right? Ones that affect 200,000 people or less, 7000 rare cancers we know of, uh, less than 95% have a treatment. It's going to be horrible if we have effective screening that shows us these cancers in the population.
▶ 2:31:33But then if we don't fund the research for the therapeutics to give no solution to them, uh, then, uh, the us government is not doing right by the american citizen. And I think congress has an ability to address that, both by restoring the funding cuts have been proposed for nih and nsf. Um, but also passing legislation we're talking about here today. >> well, thank you so much, Mr. mike ezell. And I agree with you.
▶ 2:31:56And I want you to know and for everyone to know that there are many of us over here who are working to restore those cuts, to cancel the cuts, to make sure, uh, that we are prioritizing the health and safety of the american people and investing in this research and in, um, in these kinds of, uh, advances. >> I'm sure that r&d funding is the seed corn of america's future. It's a seed corn of the technologies in the industries and the jobs of tomorrow.
▶ 2:32:21And this generation has a responsibility to future generations to make those investments, just like generations did before. There needs to be an intergenerational compact in this congress and this administration to understand that these investments are critical for our, you know, economic and national security future. >> well, thank you so much. I could not have said it as better or as succinctly. I do have another question for you that I will submit for the record on the topic of cuts. Hugely important. Thank you. Uh, and thanks to all of you for your work. And with that, Mr.
▶ 2:32:53Chairman, I yield back. >> gentlelady yields back. Now, recognize the gentlelady of iowa, miss miller-meeks. Excuse me, doctor miller-meeks, for her five minutes of questioning. >> all right. Thank you very much, chairman griffin and ranking member degette for holding this important hearing today. And I also want to thank our witnesses for taking time to testify. Uh, as a physician, I think the bills before us today that we're discussing are extremely important.
▶ 2:33:15We also know that medicare is on pace to spend 1 trillion treating cancer over the next decade, and approximately 1 million medicare beneficiaries will be diagnosed with cancer this year. This unfortunate reality is that much of the treatment will be limited and has far too many of these cancers are caught too late. Late stage cancer cancer diagnoses are the deadliest. Require treatments that take the hardest toll on patients and cost the most to treat.
▶ 2:33:42It's why I was proud to coauthor the nancy gardner sewell medicare multi-cancer early detection screening coverage act with my colleagues representative hudson arrington, sewell, ruiz, and kelly. This critical legislation gives cms the authority to cover multi-cancer early detection tests once they're approved by the fda, ensuring our nation's seniors have access to groundbreaking innovation that will transform how we diagnose and prevent cancer progression.
▶ 2:34:09And as we know, once covered by medicare, we would see it covered by other payers as well. If we're going to win the war on cancer and defeat this common enemy, we have to unleash the power of innovation. I also want to thank our audience here with the american cancer society for their support of this legislation. And that's what this legislation does. It's what physicians, cancer experts and patient advocate communities are calling on us to do to early detect and unleash the power of innovation to do so.
▶ 2:34:40I'm especially proud of the fact that this bill is truly the most popular healthcare bill in congress, having earned the support of over 300 co-sponsors and hundreds of cancer, uh, health, rural and medical societies who recognize its transformative potential. Mr. royce, for patients, the experience of being diagnosed with cancer at stage one or stage two versus stage 3 or 4 can mean very different treatment plans and outcomes. It can also mean the difference between life and death.
▶ 2:35:07Here's just one example the five year cancer survival rate for stage one colorectal cancer is over 90%, but it drops to around 15% when found at stage four. Can you speak to how early detection changes, treatment options, quality of life and return to productivity for cancer patients? >> I can thank you. And you know, I misspoke earlier when I when I gave the statistics, I said the survival rate for stage four pancreatic cancer is 13%. It's actually 4%.
▶ 2:35:37So the difference is at stage four 4% chance five year survival rate stage localized, which is 1 or 2 is a 44%. And those numbers are going up. Treatments are getting better. But it's important to note that especially in pancreatic cancer, we've heard about how we're getting better at treating cancer or detecting it at least and treating it. But not all cancers.
▶ 2:36:02Pancreatic cancer has been increasing over the years, over the last ten years, last 20 years, last 30 years, it has increased. So there's something going on here that we really don't understand. And that makes it. And it might be partly because there is no test like there is for colorectal, just specific to pancreatic cancer. In fact, I would say mce is the only test I know of that you could use to find the sort of cancer. >> thank you, Mr. ezell. You wrote a paper that calls mce a transformative opportunity.
▶ 2:36:31Why do you call it transformative? >> well, because you know what is driving so much of the biopharmaceutical industry for today is this marriage of biochemistry and information technology, right. You look at the ability of artificial intelligence to identify new drugs, the protein folding, um, you know, understanding the morphology of cells and how you can deliver therapeutic in the body to adhere to that cancer cell.
▶ 2:37:00And even the companies developing cancer nanotubes that could, in theory, kind of go into the body like a cancer mousetrap and suck it out of the body. So this is artificial intelligence, machine learning, and this is the marriage of these technologies. And I think that's why. And, you know, they're evolving. We have 600,000 patients in clinical trial for this now. But as I said earlier, I think now that we have an information technology element and always on, always learning approach to cancer detection, I think that's you.
▶ 2:37:31>> and if I can ask because my time is running out. Um, um, we just heard some criticism about the federal government spending. Uh, and having been in an academic medical center on faculty, um, I would see the benefits of, uh, research funding by the nih. But then that, taken as we've seen by our witnesses today, into the private sector, into starting a new business and an entrepreneurial business.
▶ 2:37:55So is there a, you know, some benefit to having, uh, the nih share in something that's taken to the marketplace, I.e. Having royalties? Has anybody thought of that? And wouldn't that be another way to help fund nih and research through the united states, yes or no? Because we're out of time. >> there's complementarity in public and private investment in r&d.
▶ 2:38:19And what the taxpayer gets when they fund the nih is that basic research looking at biochemistry, understanding biomarkers in the body when they pay for a drug, they're paying separately for the clinical trial activity and development to bring a drug. >> I think that's very valid that there is both public and private research, and the federal government is not the only source of research and research funding. With that, I yield. >> thank you. Gentlelady yields back. Now recognize the gentleman from louisiana, Mr. carter, for his five minutes question. >> thank you, Mr. chairman. Ranking member, for holding this hearing.
▶ 2:38:48And thank you for our witnesses participating. Cancer touches every one of us. Nearly 40% of americans will receive a cancer diagnosis in their lifetime. That's more than a statistic. It's millions of stories of hardship, courage, and loss. Each year, over 600,000 americans die from cancer, and the burden falls heaviest on our seniors, with the median age of diagnosis at 66.
▶ 2:39:17But today, we're not just talking about impacting cancer. We're talking about the opportunity to change the future. H.r. 842, the nancy gardner sewell medicare medical multi-cancer early detection screening coverage act is a bipartisan, common sense step forward, authored by my dear friend terri sewell and with 290 co-sponsors in the house, this bill would ensure timely medicare medicare coverage for
▶ 2:39:47Multi-cancer early detection test. Upon receiving fda approval, unlocking the possibility to detect dozens of cancers before symptoms may appear. We know early detection saves lives, cuts costs, and improves outcomes. We also know the current status quo, where 70% of cancer deaths come from cancers without screening is absolutely unacceptable.
▶ 2:40:12Cancer doesn't care about political parties or zip codes, and neither should we. Together we can make h.r. 842 the law of the land and bring us one step closer to a future where fewer families are devastated by this dreaded disease. And while I'm encouraged to see this bill getting a legislative hearing with bipartisan support, I will be remiss if I did not mention the attack on science and cancer research by the trump administration.
▶ 2:40:41We're in this committee room right now talking about innovation, therapies and technologies. Yet the very research essential to developing life saving cures and treatments are being politicized and even dismantled by our president. My republican colleagues want to hold these hearings to discuss healthcare advancements and operate as business as usual, but democrats will not be silenced.
▶ 2:41:05We will continue to demand answers and accountability, just as we did in june with secretary kennedy appeared before this very committee. We will continue to sound the alarm and make sure all american people know exactly what's happening. Cancer knows no party. It knows no political bounds. We have to treat it just the same. Mr.
▶ 2:41:26Eisele, in your testimony, you talked about the united states leadership in developing multi-cancer early detection screening tests and the importance of establishing regulatory pathways and coverages for these technologies to remain globally competitive. How do federal research funding cuts affect the united states leadership in biomedical research and innovation? >> as I stated earlier, congress.
▶ 2:41:55Congress member of federal r&d funding is a seed core for future generations of innovation, and it is absolutely foundational to american leadership in biopharmaceuticals. Over the last 35 years, the number of innovative drugs coming out of the united states and europe completely flipped. And that was a result of concerted, thoughtful public policies, including robust levels of public and private investment in r&d that made america the world's leading research. >> to identify.
▶ 2:42:25To build on is common sense. It's about as basic as you get, right? >> yes, sir. >> uh, if we're going to be remain competitive in a global market and making sure that we are stepping ahead, we have to research, uh, our secretary. >> for million dollars. >> and he said we hadn't found a cure to cancer yet. We hadn't found a cure to aids. So we're going to stop testing. I can't wrap my brain around that level of thinking we have.
▶ 2:42:50We have come up with ways to to live longer to mitigate the effects of cancer, all through research. We should continue to to put money into research, not not go back. I only have a few seconds. I want to get to, uh, Mr. royce. Um, Mr. royce, you're testifying here today. Shared experience with pancreatic cancer. Thank you for being here and sharing your story.
▶ 2:43:13As you know, um, currently, we only have routine screening for a handful of cancers, including breast cancer, cervical cancer and colorectal cancer. How will h. H.r. 42 help fill current gaps in cancer screening, and what difference could it make for patients who may not have screening options available today? >> thank you very much. So current mrd testing the liquid biopsies can test for up to 50 different cancers right now.
▶ 2:43:43So in my case, for example, as you've noted, there's no screening specific to pancreatic cancer. But my liquid biopsy found it. >> so as a result more obviously is better than yeah. >> yes. >> and that is determined through effective research testing and utilizing every tool that we have in our toolbox to fight back against cancer. >> I certainly think so. Thank you. >> Mr. chairman. >> and I now recognize the gentleman from california, Mr.
▶ 2:44:13Obernolte, for his five minutes of questioning. >> thank you. >> Mr. chairman. >> thank you to our witnesses. Uh, I find this a really not only interesting, but critically important topic. Uh, this technology has the potential to accomplish these seemingly contradictory goals of, at the same time, improving patient outcomes, but also reducing healthcare expenditures. And I find that incredibly exciting. Uh, Mr. I wanted to start with you.
▶ 2:44:39Uh, the we've been having this discussion about false positives and false negatives, and I think chairman griffith asked you about the false negatives, and you had a kind of a fulsome discussion about that.
▶ 2:44:53Doctor zuckerman brought up some research that has been talking about false positives and false negatives and, and particularly, uh, the annals of internal medicine had an article recently where it said that it's unclear whether unclear whether these tests detect cancer at a later, untreatable stage or whether they detect very early stage precancerous lesions that might have never developed into cancer. So I find this concerning from the standpoint of false positives.
▶ 2:45:20If I'm a from a patient standpoint, if I'm a patient, I would rather have you tell me I might have cancer and then so I can do some more research even if I don't. But, you know, how do we how do we parse this, this middle case where we're detecting cancer that is actually there, but it's a precancerous lesion that actually in real life, if we've done nothing about it, would never develop into cancer. So, I mean, how should we be thinking about that kind of outcome?
▶ 2:45:44>> I guess the first point I would make is that these tests are being intentionally designed to try to ferret out the most aggressive cancers that are the fastest growing, and not the indolent cancers. I'd also note, as, um, columbia university professor of oncology azra rossi says, um, the 27 billion americans spent on cancer screening in 2020 yielded about 9 million positive results annually.
▶ 2:46:07Of those, only 204,000 turned out to be actual cancers, with 8.8 million being false positives. So this is a challenge we currently confront of false positives in the current screening paradigm. And I believe that given a very low false positive rate, the tests are going to be significantly higher than single cancer screening over time in terms of their positive predictive value.
▶ 2:46:32>> so would you in this particular case where you've got a precancerous lesion that could develop into cancer at a later stage and you detect that, is that a false positive? >> I'm not a scientist. I'm not a doctor. Um. Me neither. So I'm not going to, uh, speak for a medical professional who would characterize, uh, that state of a potential disease.
▶ 2:46:59I'm here today to kind of address the policy environment I think congress can put forward to support the evolution of these technologies going forward. >> okay. Thank you. Uh, doctor britton, I'll bring that same discussion to you. Uh, you know, as we think about, uh, national coverage determination, how should we be thinking about this issue of false positives and false negatives?
▶ 2:47:20Because, I mean, on its surface, if we've got technology that can simultaneously improve patient outcomes and decrease healthcare expenses, that should be a no brainer except for this issue. Like, how do we factor that in to the decision making process? >> I think we come back to one of the things I mentioned previously, which is obviously it's beneficial for patients to actually potentially obviously better outcomes reduces dollars.
▶ 2:47:44But ultimately this is a decision to be made for access, to be available for a physician and a patient to make a decision to manage a false positive or false negative, for that matter. So it's a decision. So we're providing access to the technology so that the latest technologies that we have been proven to be safe and effective are available to the medicare population, that they can make that decision with their physician. >> okay. Well, I think being patient centered probably makes sense.
▶ 2:48:08Uh, and then in a little bit of time, I have left, I wanted to ask you about, uh, the application of artificial intelligence to this process, because one of the things that I've been surprised by is that most of the low hanging fruit, in terms of the efficiencies that I can wring from the process and as regards healthcare, is with administration.
▶ 2:48:27But I can't help but think, looking at this, you know, this bureaucratic process of, uh, coverage, determination and wondering if cms might be able to use ai to make themselves more efficient, what do you think about that? >> well, I appreciate the question. And I is obviously creating incredible capabilities. I'm an interventional cardiologist, probably not the right person to answer your question about ai. >> all right.
▶ 2:48:48Well, I want to thank everyone for your engagement on this issue as we work through this and really exciting technology, really exciting times for not just technologists, but also patients in the united states. I yield back. >> if I could add. >> briefly, you got 16 seconds, but. >> go ahead. Artificial intelligence can transform government operations, and every single agency of the us government should have a strategy for how it can deploy artificial intelligence to accelerate and improve delivery of constituent services. >> yeah, well, I would hope everyone would be in furious agreement with you on that. Thank you. I yield back, Mr. chairman. >> gentleman yields back. Now.
▶ 2:49:19Recognize the gentleman from ohio, Mr. landsman? >> thank you. >> Mr. chair. And thank you, ranking member. Thank you all for your your testimony. Uh, today, Mr. royce, you in particular, um, your stories is so important. Uh, I mean, one thank god, uh, that you, uh, got the screening that you did. Um, and juxtaposed to the loss of your brother, uh, who didn't?
▶ 2:49:47And, um, you know, so much of what we do in hearings like this, understandably, is to ask questions and to push and prod and talk about the data and the, you know, the, you know, the trappings of a false all of these things that we should. But ultimately, as you said, I think very powerfully, you know, I'm not a statistic. Like at the end of the day, we had a scare with our son. You could argue it was a false positive. He was three years old.
▶ 2:50:15They thought he had leukemia or lymphoma. They said, hopefully we're wrong, but we want him in immediately to to go through all the the screens and the tests and everything like that. And so it was a it was a terrible few days. Uh, but it doesn't bother me that they did that. I, I'm glad that they did that.
▶ 2:50:36Uh, and so as we think about this kind of policy work, like, it's okay if there's a false positive, it's okay if there's errors, but we have to do everything in our power to give people everything that they need to be healthy. Period. And if it costs more money, it costs more money.
▶ 2:50:52Um, I, I think the screening and the early detection work and conversation is predicated on the fact that people have health care, uh, it's hugely important, this conversation, but it assumes that folks are healthy enough, uh, or they're in a position to get these screenings, uh, to do the early detection.
▶ 2:51:19And it would be irresponsible for us to not, uh, call out the fact that we are on the verge of a true american health crisis. And it's our responsibility as the united states congress, uh, to to fix that, there are three, uh, undeniable, un-american aspects of this american health crisis that we have to address.
▶ 2:51:48Number one is that congress voted to, uh, strip $1 trillion, uh, cut $1 trillion out of our health care system. More than 10 million americans are going to lose their health care. Rural hospitals will close. Long term care facilities will close.
▶ 2:52:05And if action isn't taken this week or next, uh, there's about 1.5 million americans who will lose their health care because, uh, we did not extend, uh, or they did not extend the, the, the health care premiums that they desperately need. The second is the cancer research that has come up, uh, 37% proposed cut and cancer, cancer funding, billions of dollars are gone.
▶ 2:52:33Uh, according to the journal of clinical oncology, for every $326 that we spend researching cancer, it extends a person's life by one year. So think about what a billion, what billions of dollars is going to do. Um, and then the third is the vaccine piece. And the fact that there's this advisory committee, uh, at hhs meeting right now, and one of my colleagues talked about hepatitis b and the fact that that may be coming back.
▶ 2:53:01And this, you know, the 90% of children who get it, I mean, that's going to end in, you know, liver failure. So I think it's important for us to get these bills done. And your testimony has been incredibly helpful.
▶ 2:53:18Uh, but the I, the prospect of the measles coming back, hepatitis b, mumps, rubella, the billions in cuts to cancer research, the trillion dollar cut to health care. We have a larger health care crisis that has to be addressed. We have to fix it. We have time to fix it.
▶ 2:53:41Uh, and my hope is that this body restores those health care cuts, uh, and protects people's premiums in this continuing resolution. Uh, and it would just be irresponsible for me if I didn't say that, uh, having the opportunity to speak before all of you and my colleagues, uh, because we have the opportunity, the capacity and the time to get it done. So I want to thank you all for being here and everything that you do. And I yield back.
▶ 2:54:12>> gentleman yields back. Now, recognize the gentlelady from florida, miss cammack, for her five minutes of questions. >> thank you, Mr. chairman. And thank you to our witnesses. Um, this is this has been an interesting conversation today. An important one. Uh, but some interesting commentary that's that's popped up along the way. Now, of course, for the more than 68 million americans who rely on medicare, including over 5 million in the sunshine state, uh, florida.
▶ 2:54:39For those of you unaware, what the sunshine state is, uh, timely access to innovative medical technologies is critical. So whether it's early cancer detection, breakthrough devices, or better management of diabetes, these tools can save lives and improve quality of life. Yet too often, and we've seen this time and time again cms they're slow, they're confusing, and many of the processes are, uh, arbitrary.
▶ 2:55:06Patients are left waiting years for access to technologies that have already been cleared by fda. The red tape doesn't just stifle innovation. It denies seniors the care they need when they need it most. Now, as policy makers, our responsibility is to make sure that medicare serves patients, not the bureaucracy. And that means transparency in coverage decisions, accountability at cms, and removing barriers that stand between seniors and life saving innovations. And as I said, I've appreciated today's conversation.
▶ 2:55:35But most importantly, I'm looking forward to working with my colleagues to advance common sense reforms. And I know that common sense isn't common here on capitol hill, but we're working through that, and we want to support innovation and ensure that seniors not just in florida but across the country, have access to the very best care. So I'm going to start with you, doctor britton. Uh, you mentioned the, the reviews and and duplicative systems, the the burdensome requirements over at cms.
▶ 2:56:03Can you give 1 or 2 concrete, very specific examples where the red tape wasted time and money without improving income outcomes? >> yeah, I think the best example I can say is currently the national coverage decision for tavr, which has been demonstrated to be a triple win. Obviously, mortality benefit, reduction in cost, quality of life improvement. And yet it because of restrictions. Now basically it's not available to all medicare beneficiaries.
▶ 2:56:30It's not available because the restrictions are that it has to be done in certain centers that are large enough, typically not in the vulnerable communities that's available to, because that that's the restrictions based on the original idea. In 2012, when we rolled it out that we wanted to start slow, we wanted to roll it out slowly and find out who would benefit from it. But we're kind of past that point. So now we're actually sitting here in 2025 and we don't we're living with the same thing we were talking about in 2012 with the mild revision in 2019. >> okay. Is there another example? You can cite.
▶ 2:57:00>> another example I can cite of. >> just red tape and and the delays specific concrete examples on cms specifically. >> I think that cms first of all, cms has been, you know, to the best of their ability, a partner for us. And we've worked with them very, very closely. Yes, there are problems with cms, no doubt about it, but they've been a very good partner. They've been very transparent with the process. I would say probably the best example I can give you is that we went through this pilot and although we wanted to actually have coverage immediately, that was the intention.
▶ 2:57:26It was 13 months from authorization to ultimately national coverage decision, when a plan could have been done earlier for using sed for that coverage. >> absolutely. Um, and I'm going to kick it to you, doctor, to to Mr. ezell, you've warned about china racing ahead in multi-cancer early detection and other technologies. So if cms keeps dragging its feet on this, do you believe that american innovators will take their research and investment overseas?
▶ 2:57:48We've of course, seen the the challenges and some of the outcomes where that's happened before, but that ultimately would leave our seniors here in the us waiting while other countries move ahead. >> absolutely. Uh, this is a rapidly innovating global field. There are competitors in europe. There are about at least a half dozen competitors in china. Um, it's important that the united states continue to be at the forefront of the, of the field, which we were the ones to pioneer and create.
▶ 2:58:18And congress, uh, by creating this pathway can send an important signal to innovators that this is an industry ripe for innovation. >> well, and I'll just piggyback on that, bringing it back home. We know that innovation and leading is important in this space, but we also have people falling behind here at home in rural america, and there's a lot of attention that gets drawn to the urban centers in major cities. But rural america is hurting in more ways than one. So how can we?
▶ 2:58:46And especially in a district like mine where my seniors are in predominantly rural areas, how do we make sure that the breakthrough technologies that we've invested so much in, um, are actually making it to these areas? Because what we've seen is the rural hospitals, um, they're behind on getting this type of technology for the people that they're designed to serve.
▶ 2:59:08>> so in the uk, the national health service is doing a test of grail's galleri system, and what they've done is deployed mobile phlebotomists to out across the entire uk to go into rural communities and do the blood draw which the ems relies on. And it's a more accessible, less invasive type of cancer detection. And it is really poised to help us address this issue that cancer rates in america's rural communities are 14% higher than in urban areas.
▶ 2:59:35By the way, I just wanted to note that, um, professor otis brawley at johns hopkins university points out that for a woman detected with breast cancer, her five year fatality rate is twice what it is in mississippi than massachusetts. Yes, and the issue of access to leading health care is real in the united states. And nasa can help us address that challenge. >> and I appreciate the the grace that the chairman has given us, and we're very far over our time. But thank you for mentioning the mobile clinics.
▶ 3:00:03And that is exactly why we need to deploy mobile clinics in every congressional district for screening for women's health care. So thank you for that. >> and the gentlelady yields back and I thank the gentlelady I see no further members of congress, uh, wishing to ask questions. Uh, so I would ask unanimous consent to insert in the record the documents included on the staff hearing document list. Without objection, so ordered. I would also like to thank all the witnesses again for being here today. This has been a very helpful discussion. Um, members may have additional written questions for you all.
▶ 3:00:32I will remind members that they have ten business days to submit those questions, for the record, and I'll ask the witnesses to respond to the questions promptly once they receive them. Members should submit their questions by the close of business on thursday, october 2nd. Without objection, subcommittee is adjourned.