A bill to amend the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users to correct a reference relating to a transit project in Orleans Parish, Louisiana.

Mr. President, we have the opportunity this year to help a group of Medicare beneficiaries who are currently subject to costly, bureaucratic red tape which is delaying essential, life-saving treatments to some of our most vulnerable citizens. Addressing this problem will increase the quality of life for many patients and ease financial burdens for their medical providers.

Between 6,000 and 10,000 Medicare beneficiaries have primary immunodeficiency diseases, PIDD, and require intravenous immunoglobulin, IVIG treatment to maintain a healthy immune system.

Primary Immunodeficiency Diseases are disorders in which part of the body's immune system is missing or does not function properly. These disorders are caused by intrinsic or genetic defects in the immune system. Untreated primary immune deficiencies result in frequent life- threatening infections and debilitating illnesses. Even illnesses such as the common cold or the flu, while unpleasant for most of us, can be deadly for someone with PIDD.

Because of advances in our medical understanding and treatment of primary immune deficiency diseases, individuals who in the past would not have survived childhood are now able to live nearly normal lives. While there is still no cure for PIDD, there are effective treatments available. Nearly 70 percent of primary immune deficient patients use intravenous immunoglobulin to maintain their health.

Immunoglobulin is a naturally occurring collection of highly specialized proteins, known as antibodies, which strengthen the body's immune response. It is derived from human plasma donations and is administered through an IV to the patient every three to four weeks.

Currently, Medicare beneficiaries needing IVIG treatments are experiencing access problems--an unintended result of the way Medicare has determined the payment for IVIG. The current IVIG access and care issue began in January 2005 as a result of the Medicare Modernization Act under Part B, which changed the way physicians and hospital outpatient departments were paid under Medicare. The law reduced IVIG reimbursement rates such that most physicians in outpatient settings could no longer afford to treat Medicare patients requiring IVIG. In addition, access to home based infusion

therapy is limited since Medicare currently pays only for the cost of IVIG, and not nursing services and supplies required for infusion.

As a result, patients are experiencing delays in receiving this life saving treatment and are being shifted to more expensive care settings such as inpatient hospitals. In addition to incurring extra expenses, hospital-based care results in patients being in close proximity to countless microorganisms, an unsafe prospect for those who have suppressed immune systems.

In April 2007, the U.S. Department of Health and Human Services Office of the Inspector General, OIG,reported that Medicare reimbursement for IVIG was inadequate to cover the cost many providers must pay for the product. In fact, the OIG found that 44 percent of hospitals and 41 percent of physicians were unable to purchase IVIG at the Medicare reimbursements rate during the 3rd quarter of 2006. The previous quarter had been even worse--77.2 percent of hospitals and 96.5 percent of physicians were unable to purchase IVIG at the Medicare reimbursement rate.

We have a rare opportunity to fix this very real problem with a compassionate and common sense solution. We can improve the quality of life for PIDD patients and cut inpatient expenses by improving reimbursement procedures for IVIG treatments for physicians and outpatient facilities and allowing for home treatments and coverage for related services.

Today, I am introducing--along with Senators Alexander and Stabenow-- the bipartisan Medicare IVIG Access Act, a bill that will grant the Secretary of Health & Human Services temporary authority to update the payment for IVIG, if necessary based on new or existing data, and to provide coverage for related items and services currently excluded from the existing Medicare home infusion therapy benefit. This bill is endorsed by several national organizations from the patient and physician communities, including the Immune Deficiency Foundation, IDF, GBS/CIDP Foundation International, the Jeffrey Modell Foundation JMF, the Platelet Disorder Support Association, PDSA, the National Patient Advocate Foundation, NPAF, and the Clinical Immunology Society, CIS.

The patients, physicians, caretakers, researchers, and plasma donors have all done their part--now it's time for us to do ours.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise today to introduce a new bill, the Accelerating Cures Act of 2008, to enhance public and private research efforts to develop new tools and therapies that prevent, detect, and cure diseases more quickly from bench to bedside. I introduced an earlier version of this legislation in December 2005, the American Center for Cures Act of 2005, S. 2104. Fundamentally, the Accelerating Cures Act of 2008 has the same intent to promote clinical and translational research within the National Institutes of Health while incorporating many of the recommendations made from the 2003 National Academy of Sciences Report, ``Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges.''

The NIH is a successful, worldwide leader in biomedical research whose mission is to support ``science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.'' Our national investment in NIH is integral to our Nation's capacity to respond safely and effectively to public and population health threats, chronic disease prevention and management, and burdensome orphan diseases. The 2006 NIH reauthorization strengthened the agency even further, and also brought a greater focus on clinical and translational research to its mission.

The Accelerating Cures Act of 2008 would build upon the progress of NIH reauthorization and further enhance the ability of the agency to address clinical and translational research barriers. For example, it is estimated to take up to 17 years for a scientific discovery to be translated into a clinical application. This gap will not be resolved unless we take serious action to implement clinical and translational research initiatives, critically evaluate the impact of health care delivery, promote multi- and cross-disciplinary collaboration, increase the number of clinicians engaged in clinical and translational research, and foster efforts that streamline the translational development process to result in product commercialization.

The Accelerating Cures Act of 2008 would address these issues by creating new programs that fund high-risk, high-reward research, to oversee and direct promising avenues of translational research, to increase the translational and clinical research workforce, and to provide new funds and authorities to evaluate the clinical effectiveness of various treatments and procedures at the NIH. The bill expands upon existing infrastructure in the Office of Portfolio Analysis and Strategic Initiatives and encourages intra- and inter- agency collaboration to build on strengths of NIH's 27 institutes and centers and other Federal agencies such as the Department of Defense, Food and Drug Administration, and the Agency for Healthcare Research and Quality. Lastly, the Accelerating Cures Act of 2008 uniquely adds resources to guide researchers through the `Valley of Death,' a stage in biomedical development between research and commercialization where the success of an initiative is dependent on feasibility and profitability that can only be established by a market that, by definition, has not yet developed. With the bill's strengthening and broadening of the Small Business Innovation Research and Small Business Technology Transfer programs and making available resources such as the Rapid Access to Intervention Development and Translational Development programs, investigators, institutions, small businesses, and other entities, will be better suited to navigate the regulatory and commercialization processes.

To summarize, the NIH has been and continues to be our Nation's premier biomedical research investment in areas of basic science and clinical and translational research. My legislation seeks to expand upon existing clinical and translational research efforts not only to meet the healthcare needs of this Nation, but to maintain the NIH's status as the most respected research institution in the World. This bill will not only increase our overall Federal investment in the NIH, but enhance our translational and clinical research capacities overall. I urge my Senate colleagues, patient advocacy groups, and researchers to work together to bring new hope to Americans that we can fight and conquer disease.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise today to join my colleague, Senator Murray, to introduce the National Neurotechnology Initiative Act of 2008. Our bill will coordinate and accelerate federal brain and nervous system research, and will help move that research from the laboratory into the hands of patients.

It is estimated that approximately 100 million Americans--one in three--suffer from some kind of neurological illness, disorder, or injury. These include some of the most debilitating illnesses, such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, autism, schizophrenia, and stroke. They include issues with a neurological basis that often goes unnoticed, such as obesity and hearing loss. They also include issues of particular importance to Senator Murray and me: traumatic brain injury, spinal cord injury, post-traumatic stress disorder, and other neurological effects suffered by the brave men and women of our armed forces as they execute their missions throughout the world.

The total economic burden of these neurological illnesses, disorders, and injuries is estimated to be more than one trillion dollars every year. These costs include direct medical treatment, long-term care for senior citizens who have been incapacitated by a neurological disease, addiction-related costs, secondary medical costs related to obesity, and so on.

As the baby boom generation ages, the cost associated with these illnesses will increase rapidly, straining our healthcare resources even further than they already are. Now is the time to act to promote the development of diagnostics, treatments, and cures that will restore health and reduce costs.

Our armed forces too often suffer from a traumatic brain injury, which is among the primary types of casualty that disables our service members. Some soldiers also suffer from post-traumatic stress disorder as well. We owe it to these heroic warriors to help them heal as quickly and as completely as possible.

The National Neurotechnology Initiative Act is designed to address four key issues currently slowing the development of neurological treatments, and to rapidly accelerate R&D for only three percent of the annual NIH brain research budget. The first is a lack of coordination between the many agencies that conduct brain research. The bill creates a coordinating office that will help ensure that the Department of Defense, the Department of Veterans Affairs, the National Institutes of Health, and other agencies know what every other agency is doing, and that they work together toward common goals.

The second issue is insufficient coordination within the National Institutes of Health. Sixteen different Institutes, Centers, and offices within NIH conduct research on the brain and nervous system, and they have begun to work together through a program called the Blueprint for Neuroscience Research. This bill authorizes and fully funds that program.

The third issue is the need to translate basic research into treatments. Advances in neurotechnology are useless if they merely sit in the lab. This bill boosts neuroscience-related technology transfer through the SBIR and STTR programs.

The fourth issue is regulatory approval of new neurotechnology drugs, diagnostics, and devices. Brain-related treatments take much longer and cost much more to approve than other treatments. This bill will increase the timeliness and safety of the neurotechnology review process by allowing the FDA to hire and train neuroscience experts and to work with industry to develop neurotechnology standards.

The bill also supports the analysis of societal implications of neuroscience and neurotechnology, so that we know we are proceeding thoughtfully and carefully in our research.

Brain and nervous system research is an issue that has been extremely important to me throughout my time in the Senate. I have long been a supporter of the MIND Research Network, which does amazing work on these issues in New Mexico; and I have worked hard to advance our ability to treat and cure brain and nervous system diseases and disorders. I hope that this legislation will be part of my legacy in this area.

I want to thank my good friend Senator Murray for asking me to join her on this very important issue. I appreciate her commitment to advancing this important research and I look forward to working with her to pass this legislation this Congress.

Mr. President, it is estimated that 199 million Americans--or one in three--suffer from some kind of brain or nervous system illness, injury or disorder. Among these illnesses are debilitating diseases and conditions, including: Alzheimer's, multiple sclerosis, epilepsy, Parkinson's disease, and traumatic brain injury. These diseases are challenging for the patients and for their loved ones, who often have intense caretaker burdens.

In addition, our men and women fighting overseas are suffering from these conditions in record numbers. The signature injuries of the current conflicts in Iraq and Afghanistan are brain and spinal cord injuries, such as traumatic brain injury, post-traumatic stress disorder, and paralysis. For example, it is estimated that as many as 12 percent to 20 percent of servicemembers who have served in Iraq suffer from PTSD alone.

The combined economic burden of these illnesses and disorders is estimated at $1 trillion annually--and this cost is rising quickly as our population ages and our military conflicts continue. Recent discoveries are revolutionizing our understanding of the human brain, and new uses for these discoveries are emerging almost every day. At the same time, researchers still have a limited understanding of the human brain and how best to diagnose, treat, and cure its diseases. The current research system for neurological diseases is disjointed and often limits this life altering research from reaching the patients in need. For example, compared to the average drug, it costs nearly $100 million more--and takes 2 years longer--to bring a drug that treats a neurological disease to the market.

We need a targeted, coordinated, national effort to support the development of neurotechnology. It is vitally important that public infrastructure be developed to ensure that today's neurotechnology discoveries quickly become tools to improve the human condition. This research has the potential to transform highly specialized areas of medicine, computing, and defense. It could dramatically change Americans' everyday lives.

The National Neurotechnology Initiative Act addresses each of these issues. I am proud to be an original cosponsor with my colleague from New Mexico. Under this proposal, the National Institutes of Health would receive funds to coordinate research and

move research into innovative companies developing the next generation of treatments.

This legislation will also accelerate research and treatment of neurological diseases by removing key bottlenecks in the system. It will coordinate neurological research across Federal agencies, create a coordinated blueprint for neuroscience at the NIH, and streamline the FDA approval process for life changing neuro drugs--without sacrificing safety. All of this will mean more treatments faster for millions of Americans.

This act is an investment in America's neurological health. Investigation into the mechanisms and functions of the brain will lead to vastly improved understanding of brain disease and injuries and human behavior. It will give us an unprecedented ability to treat and heal those in need. The act also will dramatically reduce healthcare costs while expanding the American neurotechnology industry and creating good American jobs. Finally, this bill will help us honor our debt to the brave men and women of America's armed forces.

Today, I am proud to introduce this legislation with Senator Domenici. I thank him for his leadership on this issue, and I look forward to working with him and my other colleagues to pass this important legislation.

Mr. President, I rise today to ask that the Senate support technical corrections to a few highway bill projects in Louisiana. Specifically,

a modified alignment to a project in Lake Charles, an expanded project area for Jefferson Parish and expanded use for a project in New Orleans.

These limited technical corrections will improve transportation in Louisiana and get the dollars previously directed toward this work into the economy. Notably, the corrections do not change the previously authorized level of spending, nor do they fundamentally alter the scope of the project.

I look forward to working with the Environment and Public Works Committee to address these technical corrections.