Michael Burgess

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 3381, the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2016, also known as the Childhood Cancer STAR Act. This bill was introduced by my Texas colleague, Representative Mike McCaul; Representative Chris Van Hollen; and Representative Jackie Speier. The legislation we are considering today is important for many young Americans, as it is intended to help the most vulnerable among us: children who have been diagnosed with cancer. We have made progress in combating childhood cancer. In 1960, only 4 percent of children with cancer survived more than 5 years. Today, 80 percent of children with cancer survive, but there is work left to do. H.R. 3381 will expand the opportunities for childhood cancer research, improve childhood cancer surveillance, help improve the quality of life for childhood cancer survivors, and help ensure that there is proper pediatric cancer research within the National Institutes of Health. This legislation enjoys broad bipartisan support. It has 270 cosponsors, representing over 60 percent of the House of Representatives. Mr. Speaker, I urge my colleagues to vote ``yes'' on H.R. 3381. I reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I yield such time as he may consume to the gentleman from Texas (Mr. McCaul), the chairman of the Committee on Homeland Security, a true champion for all things pediatric.

Mr. BURGESS. Mr. Speaker, I urge all Members to vote in favor of H.R. 3381. I yield back the balance of my time.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass the bill (S. 2873) to require studies and reports examining the use of, and opportunities to use, technology-enabled collaborative learning and capacity building models to improve programs of the Department of Health and Human Services, and for other purposes.

Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days in which to revise and extend their remarks and insert extraneous materials into the Record on the bill.

Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of S. 2873, the Expanding Capacity for Health Outcomes Act, also known as the ECHO Act. This bipartisan legislation by Senators Hatch and Schatz passed the Senate 97-0 on November 29. House companion legislation has been introduced and championed by Representative Matsui and me. This legislation requires the Secretary of Health and Human Services to examine technology-enabled collaborative learning and capacity building models and their impact on the healthcare workforce, the implementation of public health programs, and the delivery of health services in rural and underserved areas to underserved populations. The bill would require the Secretary to consult with public and private stakeholders with expertise in these delivery models to evaluate their potential and larger adoption in States and within the Federal Government. Within 2 years, the Secretary then would submit to Congress and publicly post a report that includes an analysis of these programs which utilize technology in a novel manner. One such method these programs may employ is using a hub-and-spoke approach to connecting specialty and primary care workers for health surveillance and proper intervention. This holds particular promise for rural and underserved areas where it can be difficult to recruit and retain health professionals but could offer opportunities for continuing provider education and engagement. This legislation enjoys broad bipartisan support. It has been endorsed by a number of health professional organizations, including America's Essential Hospitals, the American Academy of Pediatrics, the American Medical Association, the American Nurses Association, and the National Association of Community Health Centers, to name but a few. This legislation does not impact direct spending or revenues. It offers a means by which to evaluate successful models in the private sector and opportunities to build upon them and adopt them if successful. Mr. Speaker, I urge my colleagues to vote ``yes'' on S. 2873. I reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time. Mr. Speaker, only 10 percent of physicians practice in rural areas in this country, but those areas contain 25 percent of the population. Obviously, there is a mismatch. Access to care in underserved areas is especially challenging for patients with chronic or complex conditions. Overburdened primary care providers often will have to refer complex patients to hospitals or specialists for care that actually could just as well be delivered at home. These unnecessary referrals delay care and increase costs for patients in the system. The Project Extension for Community Health Outcomes, or Project ECHO, is one example of an innovative model that is being used to address this challenge. Project ECHO uses interactive videoconferencing to link specialist teams with primary care providers in medical education clinics that include didactic teaching and case-based learning. Project ECHO has equipped local providers across the country with the extraordinary skills necessary to take on healthcare challenges threatening our communities. Project ECHO has been used to increase the number of docs able to prescribe for opioid abuse, to rapidly educate providers on public health crises, such as a novel flu outbreak, and to train providers to address complex mental health disorders. This bipartisan, bicameral bill has broad support from healthcare providers and systems. It passed the Senate 97-0 last week. Again, I want to thank Congresswoman Matsui of California for her partnership on the bill. I encourage my colleagues to support its passage. Mr. Speaker, I yield back the balance of my time.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, by the direction of the Committee on Rules, I call up House Resolution 934 and ask for its immediate consideration.

Mr. BURGESS. Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Colorado (Mr. Polis), pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate only. General Leave

Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks.

Mr. BURGESS. Mr. Speaker, House Resolution 934 provides for a rule to consider a critical bill that will help millions of Americans and their families who are suffering from diseases. The rule provides 80 minutes of debate, with 1 hour being provided to the Energy and Commerce Committee, and 20 minutes given to the Committee on Ways and Means. The rule provides for a motion to concur with the Senate amendment to H.R. 34, placing the base text of the 21st Century Cures into the bill. The rule further incorporates the manager's amendment into the base text of the Cures bill, reflecting the bipartisan and bicameral negotiations which took place to get us to where we are today with the legislation. Second, the resolution before us today provides for a rule to consider H.R. 6392, the Systemic Risk Designation Improvement Act of 2016, an important bill to remove onerous Federal regulations imposed on small and community banks by the ill-conceived Dodd-Frank Act by replacing current and arbitrary SIFI designation standards with a more effective activity-based standard. The rule provides for 1 hour of debate, equally divided between the majority and minority of the Committee on Financial Services. Further, the rule makes one amendment in order and provides the minority with the standard motion to recommit. I am pleased that the House is considering both of these pieces of legislation today. The Energy and Commerce Committee has spent 4 years working to bring our healthcare innovation infrastructure into the 21st century. Today, there are 10,000 known diseases or conditions, but the bad news is we have cures and treatments for only 500. There is a gap between innovation and therapy. There are problems with how we regulate our therapies. It is not unheard of to have a company take over 14 years and $2 billion to bring a new drug to market. Members held 20 roundtables, discussions, hearings, field hearings, and events around the country to ensure that we involved our patients, their advocates, researchers, innovators, financiers--all who have firsthand experience and who understand the gaps in our current system. The House amendment to H.R. 34 includes two bipartisan bills that have been developed over the course of several years by the Committee on Energy and Commerce and its members to meet some of our country's most pressing healthcare needs. The mental health reforms that are based on the Helping Families in Mental Health Crisis Act, authored by Representative Tim Murphy, passed the House in July by a vote of 422-2. This legislative effort represents the most significant reforms in the mental health system in over a decade. The 21st Century Cures Act title in the bill is the result of a unified Energy and Commerce Committee effort, championed by Chairman Fred Upton of Michigan and Representative Diana DeGette of Colorado over the course of multiple Congresses, to bring our laws into a modern era of medicine. The House passed the 21st Century Cures Act in July of 2015 by a vote of 344-77. Our commitment to this transformational bill has not and must not waver until it is across the finish line and signed into law. We owe it to the patients, their families, medical providers, advocates, scientists, and researchers to see this through. Our country is a global leader in medical innovation, but even in recognizing that, there is progress that we can make. With 10,000 known diseases and with 10,000 known conditions, and with cures and treatments for only 500, we must do more to alleviate that gap which is causing so much human suffering. Advances in science and technology over the past decade have the potential to revolutionize medical innovation; yet the way drugs and devices are approved is back in the horse-and-buggy days. It is largely unchanged. In recognizing the growing divide between innovation and regulation, the House Committee on Energy and Commerce launched the 21st Century Cures Initiative in the 113th Congress--that was a Congress ago--to examine the state of discovery, development, and delivery of medical therapies in America. The ensuing process by which the Cures legislation was developed should serve as a model for policy development long into the future. Members of the committee convened hearings, forums, and roundtables in Washington, DC, and in centers and locations around the Nation. These forums brought together the leading scientists, the medical experts, patient and disease group advocates, and researchers and innovators across multiple sectors. The objective of these events was to uncover opportunities and to strengthen and streamline the process by which cures are discovered and made available to patients. Based on what we have learned, Representatives worked across the aisle--across the dais--on comprehensive legislation that would make the government an ally rather than an obstacle in the cycle of medical innovation. The 21st Century Cures Act touches each step of the process through which new treatments and cures come to market: the discovery, the development, the delivery. To accelerate discovery, the House amendment to H.R. 34 includes provisions that facilitate collaboration and increase access to health data. It invests billions of dollars in research through the National Institutes of Health, and it incentivizes the exploration of the most rare and challenging conditions. To modernize the development, among other things, the 21st Century Cures Act establishes a review pathway at the Food and Drug Administration for biomarkers and other drug development tools that can be used to help shorten drug development time while, at the same time, maintaining the safety standard that the public demands and that we have all come to expect from the agency. The very confused regulation of combination products by the very different centers at the Food and Drug Administration will be improved to cut down on inefficiencies and to reduce the cost of development. The Food and Drug Administration will be required to work with stakeholders and the National Institute of Standards and Technology to establish a regulatory framework for the development, evaluation, and review of drugs that are classified as regenerative medicine and advanced therapies. A number of provisions seek to empower patients to engage in their health care and to engage in their treatment decisions with their doctors, to contribute health information to scientific research, and to participate in the drug and device approval process. The Food and Drug Administration is required to engage in a range of activities that will establish a framework for the consideration of patient experience data when weighing the benefits of a new treatment. Individuals will have the opportunity to share health data with the global research community through platforms, such as the Precision Medicine Initiative and a new National Neurological Diseases Surveillance System. Multiple measures ensure patients will have better access to secure, up-to-date information through their electronic health records, and they ensure that this health information technology will continue to be developed with patient needs and patient safety and privacy as a priority. I am grateful to have had the opportunity to work directly on several provisions in the bill. This includes the creation of a national surveillance system for neurologic diseases and conditions which may then be used to help us further understand these devastating diseases. Thousands of Americans are affected--multiple sclerosis, Parkinson's, Alzheimer's, other neurologic diseases--but there is very little accurate information that exists today to assist those who research, treat, and provide care for individuals who suffer from these diseases. I have also worked on a provision that will improve patient access to pharmaceutical companies' compassionate use policies for drugs that treat serious or life-threatening conditions. To increase the efficiency and foster robust data collection analysis, the Food and Drug Administration will be required to evaluate the use of real-world evidence and summary-level review where an application is submitted for a new indication for an already approved drug. To help insurers and formulary committees make informed coverage decisions, a provision in the 21st Century Cures Act clarifies how medical product manufacturers can communicate economic information about therapies and technologies. I am particularly happy that the House amendment to H.R. 34 includes multiple provisions that will make meaningful progress toward achieving an interoperable health system. Increasingly, electronic health system interoperability is critical to achieving the promises of the 21st Century Cures and to scaling up the benefits of health reform more broadly. While we have seen the widespread adoption of electronic health records, our Nation continues to maintain a fragmented system, which makes it difficult to ensure the continuity of evidence-based care for patients. The 21st Century Cures Act would finally set us on a path towards achieving a nationwide interoperable health system that puts the needs of patients and that puts the needs of providers first. Federal advisory committees are streamlined and directed to prioritize interoperability. Preference is directed to utilizing the existing standards of implementation rather than of recreating them. In addition to increasing the transparency and accountability for providers and patients, enforcement mechanisms will arm the Office of Inspector General with the authority necessary to punish bad actors for improperly impeding the flow of information. Data blocking will stop. The provisions in this bill will expedite the interoperability of electronic health record systems to make good on the $30 billion taxpayer investment in order to benefit patients, doctors, and researchers. As I have referenced, developing the 21st Century Cures Act was a process that brought everyone to the table. No one is getting everything that he wanted. I would note my disappointment that this bill does not include an important clarification to the Physician Payments Sunshine Act that was part of the House-passed version of this bill and was supported by over 200 supporting organizations. Certified continuing medical education, peer-reviewed medical textbooks, and journal reprints play a vital role in improving patient outcomes. They play a role in facilitating medical innovation, keeping our Nation's medical professionals up to date with the rapid pace of scientific discoveries. These materials and activities should not be confused with improper payments from pharmaceutical manufacturers to physicians. These materials were always intended to be excluded from the reporting requirements in the physician sunshine law, but, unfortunately, the Centers for Medicare & Medicaid Services' interpretation of the exemption has been inconsistent and unreliable. The narrowly constructed language in the 21st Century Cures Act was carefully drafted to maintain the transparency originally intended in the sunshine law while it ensured robust access to medical education. Mr. Speaker, I think it goes without saying that we all want our doctors to be smart, that we want them to be informed, and that we want them to be up to date. Certainly, that is a priority that I will continue to pursue going forward. Groundbreaking discoveries rely on a robust and reliable investment in basic research. The House amendment to H.R. 34 provides the National Institutes of Health with almost $5 billion in funding, including almost $2 billion for the Cancer Moonshot and $1.5 billion for the BRAIN Initiative. It also includes $500 million for the Food and Drug Administration and $1 billion in grants to four States in order to address the growing and burgeoning opioid crisis that continues to claim so many lives across our country. This approach provides dedicated funding through 2026 while it ensures spending is subject to review and oversight in the annual appropriations process. In addition to fully offsetting all of the authorized funds, H.R. 34 will actually reduce the deficit by almost $6 billion over the next 10 years. Federal regulation, Federal policy, and Federal investment have been outpaced by science, medicine, and technology. The bipartisan 21st Century Cures Act will make needed changes to bring our laws into a modern era of medicine and to keep the Nation at the forefront of healthcare innovation. The 21st Century Cures Act not only delivers hope to millions of patients who are living with untreatable diseases, but it also helps modernize and helps streamline the regulation in America's healthcare system. I encourage all of my colleagues to vote ``yes'' on the rule and ``yes'' on the two underlying bills. The 21st Century Cures Act will not only deliver hope to millions of people who are living with untreatable disease, but it will also help modernize and streamline America's healthcare system. Mr. Speaker, I reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from Pennsylvania (Mr. Murphy), the author of the mental health portion of this bill.

Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from Oklahoma (Mr. Cole).

Mr. BURGESS. Mr. Speaker, I have two additional speakers and myself to close.

Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from Pennsylvania (Mr. Pitts), the chairman of the Subcommittee on Health that played a vital role in getting the 21st Century Cures bill across the finish line.

Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from Michigan (Mr. Walberg).

Mr. BURGESS. I am prepared to close.

Mr. BURGESS. Mr. Speaker, I thank the gentleman for the accommodation. I am pleased to yield 2 minutes to the gentleman from Oregon (Mr. Walden).

Mr. BURGESS. Once again.

Mr. BURGESS. I yield myself the balance of my time. Mr. Speaker, today's rule provides for the consideration of two important bills: a bill that will transform and advance the discovery, the development, the delivery of treatments and cures; and a bill that will help our small and community banks, institutions that, in turn, can further assist small and local businesses and help our communities grow. I want to thank all of the Members who did put a lot of effort into the final package on the Cures bill, as well as the staff on both sides of the aisle, all members of the Committee on Energy and Commerce, and the House as a whole, who were asked to bring their ideas to the table, and we worked to include as many of those as we could. I would also like to express my thanks to the great attorneys at the Legislative Counsel who sometimes worked around the clock to get this bill ready for both the committee and floor activity. I want to thank Chairman Upton, Representative DeGette, as well as Chairman Pitts and Ranking Member Pallone and Ranking Member Gene Green for their leadership throughout. It has already been mentioned, but I also want to thank the staff, both in our personal offices and at the committee staff, who have worked so hard on this over the past 4 years. This was truly all hands on deck. There is not one staffer on the Subcommittee on Health of the Committee on Energy and Commerce who does not have their fingerprints all over this bill. Mr. Speaker, I yield back the balance of my time, and I move the previous question on the resolution. The previous question was ordered.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials into the Record on the bill.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I yield 4 minutes to the gentleman from Iowa (Mr. Young), the principal author of the bill.

Mr. BURGESS. Mr. Speaker, I yield 4 minutes to the gentleman from Georgia (Mr. Carter).

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and to insert extraneous materials in the Record on the bill.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials in the Record on the bill.