A LIFETIME OF SERVICE
Fighting for Quality, Affordable Health Care
Throughout his Senate career -- and especially during his service as Chairman of the Senate Health, Education, Labor and Pensions Committee -- Senator Kennedy championed the cause of quality, affordable health care for all Americans.
Throughout his Senate career, Senator Kennedy championed the cause of quality health care for all Americans. Among the many landmark laws enacted under his leadership and sponsorship are the Protection and Advocacy for Mentally Ill Individuals Act of 1986, the Nutrition Labeling and Education Act of 1990, the Americans with Disabilities Act of 1990, the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, the National Institutes of Health Revitalization Act of 1993, the Freedom of Access to Clinic Entrances Act of 1994, the Health Insurance Portability and Accountability Act of 1996, the Food and Drug Administration Modernization Act of 1997, the creation of the Children's Health Insurance Program (CHIP) in 1997 (HIPAA), the Children's Health Act of 2000, the Project BioShield Act of 2003, the Pandemic and All-Hazards Preparedness Act of 2005, the FDA Amendments Act of 2007, and the Genetic Information Nondiscrimination Act of 2008.
Pursuing Comprehensive Health Coverage
Throughout his career, Senator Kennedy fought to ensure that all Americans have access to high-quality, affordable health care. It was the cause of his life.
He began his work in 1966 in Boston, after visiting the Columbia Point Health Center -- a successful clinic bringing health care to low-income residents of the community. Kennedy came away impressed with the clinic's ability to provide treatment to low-income populations. He was aware of a similar clinic in Mound Bayou, Mississippi, and saw in the two clinics a model that could be replicated across the nation to provide more health care to people who needed it. He introduced an amendment to the Economic Opportunity Act that set aside $51 million to establish another 30 centers around the country. Today, as a direct result of Senator Kennedy's vision as a 34-year-old, first-term senator, 20 million low-income Americans receive access to quality primary care at 1,200 community health centers across all 50 states and U.S. territories.
This success was the very beginning of Senator Kennedy's long journey to make health care a right for all Americans, not a privilege of the few.
It was 1969 when Senator Kennedy, recognizing the success of Medicare for senior citizens, first called for universal health care for all Americans. "We must begin to move now to establish a comprehensive national health insurance program, capable of bringing the same amount and high quality of health care to every man, woman, and child in the United States," Kennedy said at Boston University Medical Center on December 16, 1969.
Senator Kennedy has spent his public life fighting for comprehensive health care for all Americans. Over the decades, tens of millions have benefited from his sustained efforts.
In 1985, he led the successful fight to enact the provisions in the Consolidated Omnibus Budget Reconciliation Act (COBRA), which today gives American workers the right to temporarily continue their employer health coverage when they lose their jobs and their insurance would otherwise end.
In 1996, Senator Kennedy and Senator Nancy Kassebaum sponsored the Health Insurance Portability and Accountability Act (HIPAA). The legislation ensures access to health care coverage for an estimated 25 million Americans who move from one job to another, are self-employed or have pre-existing medical conditions.
As part of the Balanced Budget Act of 1997, and through the persistent leadership of Senator Kennedy and his colleague, Senator Orrin Hatch, Congress established the bipartisan Children's Health Insurance Program (CHIP) to support state efforts to provide health insurance to uninsured children in low-income families. In combination with their own funds, states could use the federal funds to expand Medicaid coverage or establish a separate state child health insurance program.
After he shepherded the landmark measure through Congress, Senator Kennedy called it "the most far-reaching step that Congress has ever taken to help the nation's children and the most far-reaching advance in health care since the enactment of Medicare and Medicaid a generation ago."
A decade after enactment, over 7 million children were enrolled in Kennedy's program. It was reauthorized and expanded in 2009 to cover 4 million additional children, including legal immigrants who -- for the first time -- did not have to face a waiting period for access to health care coverage. More than 11 million children are expected to be enrolled annually in the coming years.
In early 2005, Senator Kennedy and 17 other senators introduced the Affordable Health Care Act. It sought to make prescription drugs more affordable by allowing importation; allow small business employers a refundable tax credit for a share of their employee health insurance costs; expand insurance coverage under Medicaid and the Children's Health Insurance programs to children, pregnant women, and legal immigrants; and utilize health information technology to improve the quality and efficiency of health care delivery for all Americans.
In 2006, Senator Kennedy and Senator Chuck Grassley passed the Family Opportunity Act, which provides states with the opportunity to expand Medicaid coverage to children with special needs, giving low- and middle-income families with disabled children the opportunity to purchase health coverage under Medicaid. The bipartisan law enables parents to work and earn above-poverty wages without fear of losing Medicaid coverage for their children. For many children with disabilities, Medicaid is the only health insurance program offering sufficient benefits to cover the required care, such as physical therapy and medical equipment. More than 250,000 children are expected to benefit from the Kennedy-Grassley provision.
From 1997 to 2008, Senator Kennedy was the central and driving force behind a sustained, bipartisan effort with historic results -- the expansion of quality and affordable health care to more than 750,000 previously uninsured Massachusetts residents.
This historic achievement was the result of four "Section 1115" Medicaid waivers given to the Commonwealth from the federal government: 1997, 2002, 2005 and 2008. The 1115 waiver allows states to vary from the otherwise strict rules governing state administration of Medicaid. Massachusetts used the waiver to greatly expand coverage to previously uninsured persons, especially through the 1997 and 2005 waivers. The 2002 and 2008 waivers were largely continuation waivers of the prior formulations.
Though Massachusetts had four governors during this 11-year period and all but one were Republicans, Senator Kennedy worked diligently, across party lines, and with state and national leaders to secure the waivers.
Moreover, Senator Kennedy's efforts regarding the 2005 waiver were particularly critical to the Commonwealth's passage of health reform in 2006. Under the 1997 and 2002 waivers, Massachusetts received substantial and extraordinary "supplemental payments" for Boston Medical Center and the Cambridge Health Alliance amounting to about $400 million a year by 2005. In 2004, looking ahead to the 2005 renewal, the Bush administration indicated their clear intent to end the supplemental payments. Senator Kennedy teamed with Republican Governor Mitt Romney to convince the Bush administration to continue the payments as long as they were used to subsidize insurance coverage for individuals and not used for subsidies to institutions. This became the essential, core formula embedded in the 2006 Massachusetts health reform law.
The Commonwealth's health reform law has been extraordinarily successful in meeting its intent. The proportion of uninsured individuals in the state dropped from about 10 percent in 2006 to about 2.6 percent in 2008. An estimated 420,000 persons have obtained quality, affordable coverage because of the 2006 law. The 1996-97 waiver led to an expansion in coverage for about 350,000 lower income individuals in the state, especially children. Senator Kennedy used the 1996-97 Massachusetts formulation as his initial model in devising what became the federal CHIP program in July 1997.
The Affordable Health Choices Act
Despite his cancer diagnosis in May 2008, Senator Kennedy provided extraordinary leadership that laid the groundwork for national health reform in 2009. Under his direction, in the summer of 2008 his staff held countless meetings with representatives from constituency groups and major stakeholders.
Balancing his work on health reform with his treatment, Kennedy stayed in constant communication with his staff and colleagues via phone and videoconferences.
And shortly after the presidential election, Kennedy divided his Committee into three working groups: Prevention and Wellness, led by Senator Tom Harkin; Delivery System Reform, led by Senator Barbara Mikulski; and Coverage led by Senator Jeff Bingaman. Together, Kennedy and the working group leaders held over a dozen hearings. Senator Christopher Dodd, the number two Democrat on the Committee and a close personal friend of Kennedy's, served as Chief Deputy for Reform.
In July of 2009, the Health, Education, Labor and Pensions (HELP) Committee passed The Affordable Health Choices Act, landmark legislation that will reduce health costs, protect individuals' choice in doctors and plans, and assure quality and affordable health care for all Americans -- the first committee in Congress to heed President Obama's call for comprehensive health reform.
The legislation builds on the existing employer-based system and strengthens it. If people like the health insurance they have, they can keep it. The bill provides better choices for those with no coverage, and for those for whom coverage is unaffordable. It also gives small businesses better options for high-value health coverage.
Under the insurance reforms in the bill, no American can be refused health coverage because of a preexisting medical condition, or be denied coverage when they need it most. No American will ever again be subject to annual or lifetime limits on their coverage, or see it terminated arbitrarily to avoid paying claims.
The bill reduces health care costs through stronger prevention, better quality of care, and use of information technology. It also roots out fraud and abuse, reduces unnecessary procedures, and creates a system that enables everyone to obtain insurance, thereby gaining access to doctors, medication and procedures essential for prevention and disease management. By sharing in this responsibility, our nearly 50 million uninsured fellow citizens will avoid eleventh-hour treatment in emergency rooms that drive up costs for everyone else.
Shared responsibility requires that everyone -- government, insurance companies, medical providers, individuals and employers -- has a part in solving America's health care crisis. The bill requires businesses that do not provide coverage for their workers to contribute to the cost of providing publicly sponsored coverage for those workers. It includes an exception for small businesses.
It also includes a strong public option that responds to the wishes of the American people to have a clear alternative to for-profit insurance companies. Like private insurance plans, the Community Health Insurance Option will be available through the American Health Benefit Gateway, a new mechanism to enable individuals and small employers in every state to find and purchase quality and affordable health insurance.
Securing Funding to Support HIV/AIDS Treatment and Care
Senator Kennedy sponsored legislation in 1986 to establish a network of education and outpatient services for individuals infected with the AIDS virus. Two years later, he successfully secured funding for the first substantial federal initiative related to AIDS treatment. Included in a catch-all health spending measure, Kennedy's provisions expanded home and community care of victims, made for easier access to experimental drugs, and created a new national commission to establish AIDS policy.
In 1990, Senator Kennedy and Senator Orrin Hatch introduced the groundbreaking Ryan White Comprehensive AIDS Resources Emergency Act, which created the single largest federal program for people with HIV/AIDS in the U.S. The law provided emergency relief to the 13 cities hardest hit by the AIDS epidemic as well as substantial assistance to all states to develop effective and cost-efficient AIDS care programs, aimed particularly at early diagnosis and home care. Other services included in the bill were drug treatment, dental care, substance abuse treatment, and outpatient mental health care. The program has been authorized by Congress three times since it was first created.
In 1991, Kennedy sponsored legislation to reorganize the Alcohol, Drug Abuse, and Mental Health Administration. Specifically, it separated the previously combined treatment and research branches of the department, which improved the capacity to effectively address both the prevention and treatment of substance abuse and mental health.
The Ryan White CARE Act reauthorization of 2000 reaffirmed Senator Kennedy's commitment to providing access for persons with HIV disease to life-sustaining medications, medical care and other essential services. The Act authorized nearly $9 billion in HIV/AIDS services over five years. According to the Centers for Disease Control and Prevention, at the time of the bill's passage AIDS had claimed over 425,000 lives in the United States, and the epidemic was infecting an additional 40,000 people each year. There is good reason to be encouraged by recent medical advances, but HIV/AIDS is hitting hardest among populations in which knowledge about the disease is limited and poverty is high. The disease continues to claim the most vulnerable Americans, especially women, youth and minorities.
In 2006, Senator Kennedy and Senator Mike Enzi led the last reauthorization of the Ryan White Act with a clear focus on bringing the legislation into the 21st century. The law now ensures that money follows the infection no matter where you live; that families are given the help they need to support a family member living with HIV; and that medical care, including drug therapy as well as support services, are a priority.
An estimated 800,000 to 900,000 Americans were living with HIV/AIDS in 2009. The federal government estimates that at least 500,000 persons rely in part or solely on CARE Act services in managing their HIV. The passage of this landmark legislation means hundreds of thousands of persons who would be unable to afford care otherwise will continue to have hope for quality care.
The law increases targeted resources to states, heavily affected metropolitan areas, community-based primary care centers, and programs that serve women, infants, youth, and families with HIV.
Creating a Federal Funding Stream to Feed the Elderly, Support Women and Children
In 1971, Kennedy introduced legislation to create a federal initiative patterned on volunteer programs in several states to feed the elderly, either with meals delivered to their homes or in group settings. Kennedy's bill established permanent federal subsidies for these programs (the first was $250 million over two years), and he fought the Nixon administration's attempts to completely eliminate funding. In 2007, 141 million meals were delivered to 916,000 individuals and 95 million meals were provided to 1.6 million seniors in community locations. It is estimated that over 6 billion meals have been served since Kennedy's bill was signed into law.
Said Kennedy on March 7, 1972: "A decade ago, elderly Americans comprised 15 percent of the nation's poor. Yet today, our senior citizens represent 20 percent of the nation's citizens who must exist on income below the poverty line. The restrictions placed on elderly Americans by their meager incomes makes it easy to understand why they have difficulty providing themselves with adequate diets.
"But more than adequate income plagues the nation's aged. The elderly, particularly the single elderly, lack the physical mobility to make weekly trips to the market. Many of them live in rented rooms with inadequate kitchen facilities. And most have little nutritional education which would permit them to prepare a balanced diet, even if there were no other obstacles," Kennedy said.
"Essentially, this measure, which I introduced early in the first session of this Congress with some 20 other senators as cosponsors, will provide a permanent nationwide nutrition program for the elderly, a program that will offer nutritious meals in a setting where the elderly can come together in social activities and in a setting where they will have access to other social services."
In 1972 Kennedy was also a prominent figure in establishing the Women, Infants, and Children Nutrition Program (WIC). The program offers food, nutrition counseling, and access to health services for low-income women, infants, and children. The first year WIC was authorized, 88,000 women and children participated. In 2008 alone, that number had grown to 8.7 million.
Enhancing Bioterrorism Preparedness
As the threat for bioterrorism increased during the last 10 years of Kennedy's Senate service, he worked aggressively to establish the governmental infrastructure necessary to protect the American public. In 2000, Senator Kennedy was the chief sponsor of bipartisan legislation called the Public Health Threats and Emergencies Act. By strengthening the nation's public health infrastructure and required planning for public health emergencies, the legislation laid the groundwork for essential improvements to our public health preparedness against bioterrorism. Senator Kennedy's planning proved invaluable when the nation faced anthrax attacks the following year.
Following the September 11, 2001 terrorist attacks and the subsequent mailing of anthrax to Capitol Hill offices, Senator Kennedy and Senator Bill Frist steered the Bioterrorism Preparedness Act into law in June of 2002. The bipartisan legislation made needed investments in the nation's stockpiles of antibiotics, helped upgrade federal capacities to prevent and detect bioterrorism, improved the state and local response efforts, and developed new treatments and diagnostics. The bill has been essential to improving America's response to infectious disease threats such as SARS and the new H1N1 flu strain.
Additionally, it provided the Food and Drug Administration increased authority to ensure the safety of the nation's food supply.
Not long thereafter, Kennedy sponsored and helped pass the Project BioShield Act, which created a federal funding stream to guide America's medical and biotechnology researchers in creating stronger defenses to bioterrorism. Universities and research institutions in Boston and across the country have capitalized on the initiative and are leading the way in developing several new biodefense countermeasures, including vaccines and immunizations. Additionally, the program accelerated research at the National Institutes for Health on biological and chemical weapons and authorized the FDA to allow the safe emergency use of unapproved medicines if needed to respond to an attack.
In 2006, Senator Kennedy worked to pass the Pandemic and All-Hazards Preparedness Act, which complements the activities of Project BioShield by streamlining the countermeasure procurement process and making funding decisions more transparent and predictable.
Providing Resources for Medical Research
As a longtime champion of biomedical research, Senator Kennedy was the sponsor of the National Institutes of Health Revitalization Act of 1993 and its reauthorization in 2003. The legislation included more than 20 titles directing the NIH to undertake research and conduct studies on various diseases and conditions, including AIDS, breast and ovarian cancer, osteoporosis and bone disorders, contraception and infertility, and prostate cancer. The law also provided legislative authority for various activities, such as the National Center for Human Genome Research, the Office of Minority Health, and the Office of Research on Women's Health. The bill permanently lifted the ban on federally funded fetal tissue transplantation research and authorized the NIH to conduct such research, created an Office of AIDS Research whose director would disburse all AIDS-related funding to the institutes, and required the NIH to convene an Interagency Coordinating Committee on the Use of Animals in Research.
Senator Kennedy consistently and aggressively fought for increased research funding through the NIH budget. His efforts paid off between fiscal years 1998 and 2003, when NIH's budget doubled from $13.6 billion to $27 billion.
Said Kennedy in 1993, "From a beginning as a one-room Laboratory of Hygiene in 1887, the National Institutes of Health have grown into one of the foremost biomedical and behavioral science research centers in the world. The research supported or conducted by NIH continues to offer the promise of improving the health, welfare and quality of life of all Americans well into the next century. With each year, the NIH discovers new scientific knowledge to improve the prevention and treatment of disease."
Two decades earlier, Kennedy was responsible for legislation that quadrupled the amount of funding for cancer research and prevention, financed with an independently-budgeted program within NIH. The day before passage in 1971, Kennedy said, "The conquest of cancer is a special problem of such enormous concern to all Americans. We can quote statistics, but I think every one of us in this body, and most families across the country, have been touched by this disease one way or another."
In 1992, amid serious concerns regarding the quality of mammography, Kennedy cosponsored and Congress passed the Mammography Quality Standards Act to ensure the safety and accuracy of mammograms as well as to promote the use of the procedure. Kennedy helped introduce the reauthorization of the bill in the 108th Congress. The reauthorization established appropriations for breast cancer screening surveillance grants, which are used to evaluate screening programs.
Senator Kennedy was a strong supporter of legislation to increase research and education on blood cancers, including leukemia, lymphoma, and multiple myeloma. While over 11 percent of all cancer deaths are attributed to these forms of cancer, less than 5 percent of federal funds for cancer research are dedicated to prevention and treatment. The Hematological Cancer Investment and Education Act authorized the NIH to expand and coordinate blood cancer research. It also directed the Department of Health and Human Services to provide information to patients and the general public to raise awareness of the disease.
On March 26, 2009, Senator Kennedy and Senator Kay Bailey Hutchison introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address cancer. The bill provides funding for promising research in early detection, and supply grants for screening and referrals for treatment. These measures will also ensure patient access to prevention and early detection, which is supplemented by increased access to clinical trials and information. The bill places an emphasis on strengthening cancer research and the urgent need for resources to both prevent and detect cancers at an early stage. The bill strives to give scientists the tools they need to fight cancer and to understand more thoroughly how the disease works.
Senator Kennedy also fought to improve screening rates for diseases such as colorectal cancer. As he worked to ensure provisions granting colorectal cancer screening to Medicare beneficiaries, Senator Kennedy in the 108th Congress introduced the "Eliminate Colorectal Cancer Act," which would have made colorectal cancer screenings available to many Americans.
Senator Kennedy has been a strong advocate of health services research, including research on what makes health care effective. He supported provisions in the American Recovery and Reinvestment Act of 2009 to put $1.1 billion toward comparative effectiveness research.
Working to Reduce Medical Errors and Preventable Death
After learning that preventable medical errors were the eighth leading cause of death in the United States, Senator Kennedy pursued legislation to improve patient safety.
In 2004, he sponsored a bill to provide legal protections to those willing to report medical errors. By calling for a patient safety research environment centered on reporting and analyzing as opposed to punitive action, the bill encouraged health care providers to report information on errors. The Senate and the House of Representatives both passed versions of Senator Kennedy's bill, but the legislation stalled in conference committee.
In 2005 and again in 2007, Senator Kennedy introduced bipartisan legislation to reduce medical costs and improve the delivery of health care by encouraging the use of health information technology. In 2009 Senator Kennedy championed provisions of the American Recovery and Reinvestment Act that included $19 billion in incentives for the adoption of health information technology and strong protections for patient medical information.
The Department of Health and Human Services predicts that health IT can save Americans $140 billion in health care costs each year. Nationally accessible computerized medical records can warn doctors when a prescription may be potentially harmful to a patient, regardless of where the patient is located in the country. In addition, health IT can issue reminders for screening tests that can prevent certain disorders, and enables doctors to look at a patient's entire medical record, and obtain the most complete representation of a patient's needs. Senator Kennedy's legislation will accelerate the development of standards for health IT, improve the effectiveness of this promising technology, and provide grants to hospitals to convert to the system.
Protecting Children and Consumers from the Deadly Effects of Tobacco Products
For over a decade Senator Kennedy led the battle to give the FDA power to regulate tobacco products, the most lethal of all consumer products. The legislative journey was long and arduous but, in the end, Kennedy's bill marked more than a victory for him and others who long championed the cause. It was a life saving act for the millions of children who will be spared a lifetime of addiction and premature death.
At the time of bill's enactment, smoking was the number one preventable cause of death in America. Smoking and smoking-related illness killed more people than automobile accidents, alcohol abuse, illegal drugs, AIDS, murder, and suicide combined. Yet prior to Kennedy's landmark legislation, the FDA -- the federal agency most responsible for protecting the public health -- was powerless to deal with the enormous risks of tobacco use.
His legislation was supported by the American Cancer Society, the American Heart Association, the American Lung Association, the American Medical Association, the Campaign for Tobacco-Free Kids and over 80 other national public health organizations.
Kennedy's bipartisan victory gave the FDA the authority to, among other provisions, make tobacco products less toxic and less addictive for those who continue to use them; provide for more explicit warning labels on the negative effects of cigarettes; prevent the tobacco industry from misleading the public about the dangers of smoking; and prohibit tobacco advertising specifically targeted to children. The entire cost for FDA's regulation is paid by the tobacco companies, apportioned among the companies based on their market share.
When the bill was signed into law, Kennedy said: "Today is a day for special celebration as President Obama signs into law this long-overdue authority for FDA to regulate tobacco products. Decade after decade, Big Tobacco has seduced millions of teenagers into lifetimes of addiction and premature death. Enactment of this legislation will finally put a stop to that. It is truly a life-saving act, and a welcome demonstration that this Congress is capable of enacting major health reform."
Protecting Consumers through Enhanced Drug and Device Safety
While Senator Kennedy is well known for his efforts to seek bipartisan consensus to bring about legislative success, he was never afraid to sail against the wind if the cause was right and the end was just.
In an effort to increase consumer protection, he was the author and sole Senate sponsor of the Medical Device Amendments of 1976, which provided comprehensive regulation of medical devices for the first time ever.
"The purpose of this legislation is to protect the health and safety of the American people. It involves the regulation of life-saving medical equipment such as heart valves, heart pacemakers, hear-lung machines, respirators, IUDs and comparable equipment," Kennedy said the year before his amendments were passed by Congress and signed into law. "It is understandable that in 1933, when the Food and Drug Act was first passed, that no regulatory authority was given for medical devices because at that time the device industry was small and did not play a central role in American medicine. In 1975 the absence of device legislation is not understandable and it is not defensible."
In 1990, Kennedy worked closely with Senator Chris Dodd to pass legislation giving the FDA greater authority over medical devices. The bill gave the FDA power over devices comparable to what it already had over drugs, requiring not only premarket testing, but also follow-ups and reports of later problems.
Kennedy was the major Senate advocate for medical device user fees to improve funding for the premarket review of medical devices. He first proposed a medical device user fee in 1994. User fees were first authorized in 2002 and reauthorized in 2007.
Enhancing Food Safety
Protecting consumers was a priority of Senator Kennedy's. In 2003, Congress passed his bill to require clear labeling of the major food allergens on packaged foods and better labeling of foods that are gluten-free. Under Senator Kennedy's Food Allergen Labeling and Consumer Protection Act, 7 million Americans with food allergies can now readily identify a product's ingredients more easily and avoid foods that may harm them.
His legislation also required the Centers for Disease Control and Prevention to monitor deaths related to food allergies and directs the NIH to develop a plan for research on food allergies.
Strengthening the Food and Drug Administration
Senator Kennedy has long been an advocate for strengthening FDA review and oversight of drugs and biologics. In 1978 and 1979 he proposed significant reforms to FDA's oversight of drugs, though the bill that passed the Senate never was taken up by the House. In 1992, he was a principal advocate for prescription drug user fees, which have dramatically increased the agency's capacity to review drug applications. In 1996 and 1997, Kennedy led the battle against changes in the FDA that would have stripped the agency of authority to oversee drugs and medical devices.
In 2007, with the fourth reauthorization of the prescription drug user fee program, Congress passed landmark legislation initially proposed by Senator Kennedy to strengthen the FDA's regulatory authority over drugs after they are approved. Experts cited this act as the most significant reform of the nation's drug safety laws in a century. Because of Kennedy's efforts, the FDA now has clear authority to require post-approval labeling changes as well as studies and clinical trials of safety issues. The legislation also required registration of most clinical trials of drugs and devices, and the posting of summaries of the results of most such trials.
In 2008, in response to concerns about contaminated heparin, Senator Kennedy introduced legislation to improve the safety of pharmaceutical ingredients and strengthen FDA's response to unsafe drugs. The legislation also improves FDA's ability to monitor the safety of imported drugs and devices.
Providing Quicker Access to Generic Drugs and Follow-on Biologics
In 2003, as part of the Medicare prescription drug legislation, Congress included revisions to the Hatch-Waxman generic drug provisions. These revisions, for which Senator Kennedy was the chief Senate advocate in the conference on the prescription drug coverage bill, closed loopholes used by brand drug companies to delay entry of generic competitors for their brand drugs.
In 2007, Senator Kennedy led negotiations that forged a Senate compromise on a regulatory pathway for the approval of follow-on biologics, which if enacted would provide for safe and effective versions of biological products that are less expensive than the brand versions of these drugs.
Enhancing Mental Health Care
For decades, Senator Kennedy was a national leader in the cause of mental health care. He understood the unique challenges faced by the 54 million Americans with mental disorders.
In 1996, Senator Kennedy joined Senators Pete Domenici and Paul Wellstone to enact Mental Health Parity legislation to help eliminate unjust annual and lifetime limits on mental health coverage which differ from those imposed on other covered illnesses.
In 2000, Kennedy along with Senators Domenici and Wellstone introduced the comprehensive Mental Health Early Intervention, Treatment and Prevention Act of 2000. The bipartisan legislation addressed a wide range of mental health issues, including an anti-stigma campaign, training for teachers and emergency services personnel to identify and respond to individuals with mental illness, continuing education on mental health care for primary care physicians, suicide prevention, centers for post-traumatic stress disorders, funding to develop integrated treatment of serious mental illness and co-occurring addiction, funding for community-based services for adults and children at high risk of adverse outcomes, and jail diversion initiatives.
In 2001, Senators Domenici, Wellstone and Kennedy introduced the Mental Health Equitable Treatment Act to strengthen and make permanent the mental health insurance parity protections passed five years earlier. Congress enacted a one-year extension of the existing law, but Senator Kennedy continued to fight for lasting legislation with the Paul Wellstone Mental Health Equitable Treatment Act Amendment of 2006, which would eliminate the discriminatory treatment of mental illness by requiring insurers provide parity between mental health benefits and medical and surgical benefits.
In 2008, after more than 10 years of effort, Senator Kennedy championed historic legislation to reform the inequities in the way mental health and substance use disorders are treated by the insurance industry. This legislation, co-sponsored by Senator Domenici, assured individuals living with mental health and substance abuse issues that their mental health benefit would be treated equally with the medical-surgical benefit regarding treatment limitations and financial requirements. This meant that co-pays, out of pocket expenses, and deductibles could not be treated differently than the way medical and surgical coverage is provided. The legislation assured equity for 113 million Americans.
Better treatments and potential cures for mental illnesses were also of great interest to Senator Kennedy, who championed increased mental health research funding. Funding in this area increased from $35 million to over $70 million between 2004 and 2009.
Senator Kennedy's commitment to the citizens of Massachusetts affected by September 11th, particularly the families of victims of the terrorist attacks, was critical to the success of the Commonwealth's mental health response to the tragedy.
Soon after September 11th, the senator called together disaster relief and mental health organizations to plan a coordinated response to September 11th for the families of victims of the tragedy. His leadership provided immediate avenues for collaboration between disaster response agencies and ensured a timely and comprehensive response.
Senator Kennedy made his Massachusetts staff completely available to assist with the Department Of Mental Health's FEMA-funded crisis counseling program. His staff were in almost daily contact with DMH as well as the Massachusetts Office for Victim Assistance in order to facilitate referrals of families to counselors, assist with entitlement and relief fund issues, and help to coordinate with other state and federal agencies. His office prepared services and referral guides for families of victims, developed a comprehensive website, and assisted DMH and MOVA in providing training to counselors.
In 2005, Senator Kennedy sought to extend the period for COBRA coverage for spouses and children of victims of the terrorist attacks for an additional four months.
Supporting Massachusetts Hospitals and Health Providers
Senator Kennedy worked closely and diligently with Massachusetts hospitals and health providers to sustain their unparalleled achievements in quality health care. No state has a greater commitment and as impressive a record of success in training quality health care professionals as Massachusetts.
Senator Kennedy fought hard for the Balanced Budget Refinement Act of 1999, which restored many of the excessive cuts made by the Balanced Budget Act of 1997. As a result of the 1999 law and Senator Kennedy's efforts, Massachusetts hospitals received over $250 million over five years in payment increases under Medicare. Home health agencies in the Commonwealth received approximately $15 million over five years.
Senator Kennedy also pushed for passage of the Benefits Improvement Protection Act of 2000, under which $212 million over five years was intended for Massachusetts hospitals, $33 million for Massachusetts home health agencies and $54 million for nursing homes in the Commonwealth.
Addressing Disparities in Minority Health
Senator Kennedy has led countless efforts to address the unnecessary, yet growing disparities in health outcomes in the United States. He and Senator Bill Frist introduced The Minority Health and Health Disparities Research and Education Act in response to continued evidence showing that minority populations had significantly higher rates of death from cancer and heart disease as well as higher rates of HIV/AIDS, diabetes, and other severe health problems.
The Act was signed into law and provided over $150 million to increase research and education efforts aimed at improving overall health care for minority and underserved communities.
It specifically authorized $100 million for FY 2001 to create a new center at the National Institutes of Health to address health disparities and establish a grant program to further biomedical and behavioral research, education and training. The bill would also support minority health research at medical institutions and establish a loan repayment program to encourage more members of minority or other health disparity populations to become biomedical research professionals.
To further support research efforts, the bill also authorized $50 million in fiscal year 2001 for the Agency for Healthcare Research and Quality to identify populations with significant health disparities, examine why barriers exist, develop strategies to reduce disparities and improve access to care, and assess ways to ensure the quality and effectiveness of our health care services. It established new training and demonstration projects through the Health Resources and Services Administration for the training and education of health professionals in reducing health disparities and providing culturally competent care.
In 2006 Senator Kennedy introduced the Minority Health Improvement and Health Disparity Elimination Act, which reaffirmed his commitment to the fundamental principle that equal opportunity for all must apply to health care and a healthy life. The bill addressed health disparities through education and training, health care quality and access, research, data collection, and leadership and collaboration.
Supporting Pediatricians and Children's Hospitals
Until Senator Kennedy changed the law, the federal government paid hospital physician costs out of Medicare, the popular health program for America's elderly. As a result, children's hospitals -- which train a third of the nation's pediatricians and pediatric specialists -- were neglected. In 1999, Congress enacted the Healthcare Research and Quality Act, which established the Children's Hospitals Graduate Medical Education Program. The program provides federal funding to support graduate medical education at children's teaching hospitals, comparable to the funding that adult teaching hospitals receive through Medicare.
Since the program's inception, children's teaching hospitals have reversed the decline in the number of pediatric residents trained. CHGME enables these hospitals to provide programs that increase diversity and promote practice in underserved areas. For example, Children's Hospital Boston has a Minority Physician Training Project that supports the development of residents from underrepresented racial and ethnic minority groups. In general, CHGME provides vital support to children's teaching hospitals, which serve as a critical health care safety net: almost 50 percent of the patient care that these hospitals provide is for low-income children, including those covered by Medicaid and those who are uninsured.
In fiscal year 2009, Congress appropriated $310 million for CHGME. Since the program was established, it has provided more than $1.1 billion to children's teaching hospitals.
It supports about 60 freestanding children's teaching hospitals that train about 30 percent of all pediatricians and about half of all pediatric subspecialists.
Fighting for Increased Funding for Vaccinations
Vaccines are among the most effective public health interventions, preventing deaths and injuries from diseases such as diphtheria, tetanus and hepatitis. For decades, Senator Kennedy fought to increase funding and resources to increase childhood immunization rates in the United States. He enacted laws strengthening the National Immunization Program and championed federal funding of the Vaccines for Children Program, which purchases pediatric vaccines for all Medicaid-eligible, uninsured, under-insured and Native American children. The National Immunization Program and the Vaccines for Children program provide over $1.3 billion in vaccines to children in Massachusetts and across the country each year.
Despite these advances, approximately 19 percent of preschool-age children in Massachusetts have not received the childhood vaccines recommended by the government and the American Academy of Pediatrics. Moreover, an average of 40,000 Americans die every year from flu-related illnesses, making pneumonia and influenza together the fifth leading cause of death among older Americans. Yet influenza vaccine can prevent up to 50 percent to 60 percent of hospitalizations and 80 percent of deaths from influenza-related complications among the elderly.
In response, Senator Kennedy and Representative Henry Waxman introduced legislation to improve adult immunization rates and promote more efficient distribution of influenza vaccine to the elderly and other populations at greatest risk.
