The Healthcare Systems Bureau is part of the Health Resources and Services Administration (HRSA), of the United States Department of Health and Human Services .
59-515: HRSA oversees the nation's organ and tissue donation and transplantation systems, poison control and vaccine injury compensation programs, and a drug discount program for certain safety-net health care providers. The Healthcare Systems Bureau was formerly the Bureau of Health Resources Development, which was created at the end of the Public Health Service reorganizations of 1966–1973 by combining
118-462: A no-fault system for resolving vaccine injury claims. Compensation covers medical and legal expenses, loss of future earning capacity, and up to $ 250,000 for pain and suffering; a death benefit of up to $ 250,000 is available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims. Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award,
177-402: A causal relationship. In 2008, the federal government settled a case brought to the vaccine court by the family of Hannah Poling , a girl who developed autistic-like symptoms after receiving a series of vaccines in a single day. The vaccines given were DTaP , Hib , MMR , varicella , and inactivated polio . Poling was diagnosed months later with encephalopathy (brain disease) caused by
236-453: A claim with the Court of Federal Claims requires a $ 402.00 filing fee, which can be waived for those unable to pay. Medical records such as prenatal, birth, pre-vaccination, vaccination, and post-vaccination records are strongly suggested, as medical review and claim processing may be delayed without them. Because this is a legal process most people use a lawyer, though this is not required. By 1999
295-420: A claimant must have experienced an injury that is named as a vaccine injury in a table included in the law within the required time period or show a causal connection. The burden of proof is the civil law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare. The VICP covers all vaccines listed on
354-500: A different destination: The rapid shifts in organizational names and structures did not go unnoticed. One employee recalled that a common joke at the time was, "If my boss calls me while I'm gone, find out who it is." A 1969 publication about CPEHS contained the editor's note, "Another reorganization of the Food and Drug Administration has occurred since this paper was prepared. Even though these organizational details are no longer accurate,
413-612: A mitochondrial enzyme deficit, a mitochondrial disorder ; it is not unusual for children with such deficits to develop neurologic signs between their first and second years. There is little scientific research in the area: no scientific studies show whether childhood vaccines can cause or contribute to mitochondrial disease, and there is no scientific evidence that vaccinations damage the brains of children with mitochondrial disorders. Although many parents view this ruling as confirming that vaccines cause regressive autism, most children with autism do not seem to have mitochondrial disorders, and
472-464: A person's natural environment but also the products they consumed. Ultimately four discrete reorganization orders would occur during this period: Reorganization Plan No. 3 of 1966; HEW reorganization order of April 1, 1968; HEW reorganization order of July 1, 1968; and HSMHA reorganization of October 31, 1968. The collective effect of these reorganizations was to split BSS split three ways into an interim bureau structure, with each part having
531-525: A petitioner either establishes a "Tabled Injury" or proves "causation in fact" by proving three prongs: This ruling held that tetanus vaccine caused a particular case of optic neuritis , even though no scientific evidence supported the petitioner's claim. Other rulings have allowed petitioners to gain awards for claims that the MMR vaccine causes fibromyalgia , that the Hib vaccine causes transverse myelitis , and that
590-404: A related donor. Stem cells for transplant come from adult volunteer donors and umbilical cord blood units donated to public cord blood banks. The program recruits adult volunteer donors, helps member cord blood banks collect and list additional units, and supports research to improve the results of unrelated donor transplants. HRSA awards grants to the nation's 61 poison control centers and manages
649-553: A short time, as individual components were shifted between them. This was in contrast to the decades prior and afterwards, in which organizational changes were incremental and did not substantively change the overall organizational structure of PHS. PHS first created internal divisions in 1899, when it was still called the Marine Hospital Service . Its only major reorganization since then had occurred in 1943, which collected its several divisions into three operating agencies:
SECTION 10
#1732895298310708-554: A single autonomous regulatory body. During 1970–1971, most of the CPEHS was moved out of PHS and HEW to form the core of the newly created EPA. This was accomplished in two phases, with the HEW reorganization order of January 16, 1970 and Reorganization Plan No. 3 of 1970 . Some CPEHS components remained within PHS. The Food and Drug Administration had already become its own operating division within
767-615: A vaccine, so it does not fall under the provisions of the vaccine act. The claims that vaccines (or thimerosal in vaccines) caused autism eventually had to be filed in the vaccine court as part of the Omnibus Autism Proceeding . The scientific consensus , developed from substantial medical and scientific research, states that there is no evidence supporting these claims, and the rate of autism continues to climb despite elimination of thimerosal from most routine early childhood vaccines. Major scientific and medical bodies such as
826-652: The Agency for Toxic Substances and Disease Registry was created. The Health Resources Administration and Health Services Administration would merge in 1982 to form the Health Resources and Services Administration . Two new PHS operating agencies were then formed by promoting divisions out of other operating agencies. The Indian Health Service split from the Health Resources and Services Administration in 1988. The Agency for Health Care Policy and Research split from
885-600: The Bureau of Medical Services (BMS), Bureau of State Services (BSS), and National Institutes of Health (NIH), plus the administrative Office of the Surgeon General (OSG). This setup persisted unto 1966, although there were minor reorganizations of the individual divisions within the agencies. After 1960, BSS grouped its divisions into Community Health Divisions and Environmental Health Divisions . By 1966, predecessors of several current organizations were recognizable. NIH
944-551: The Bureau of Radiological Health , which moved into FDA; and the Bureau of Community Environmental Management, which was later absorbed by EPA and CDC in 1973. The Bureau of Solid Waste Management, Bureau of Water Hygiene, and the rest of the Bureau of Radiological Health were transferred to EPA in 1971. HSMHA was unpopular with many in PHS, as they felt that it shifted the focus from PHS physicians to department bureaucrats. In addition, National Communicable Disease Center Director David Sencer became acting HSMHA Administrator at
1003-526: The Health Services and Mental Health Administration (HSMHA) and the Consumer Protection and Environmental Health Service (CPEHS). The goal of the reorganizations was to coordinate the previously fragmented divisions to provide a holistic approach to large, overarching problems. However, the new agencies came to be seen as unwieldy and bureaucratic, and they would turn out to be short-lived. CPEHS
1062-573: The Institute of Medicine and World Health Organization , as well as governmental agencies such as the Food and Drug Administration and the CDC reject any role for thimerosal in autism or other neurodevelopmental disorders. As of May 2023, nearly $ 4.6 billion in compensation and $ 450 million in attorneys’ fees have been awarded. The following table shows the awards by main classes of vaccines made to victims in
1121-773: The Medicare prospective payment system . As reported in the Department of Health and Human Services 2014 Justification of Estimates for Appropriations Committees, the 340B program cuts drug costs for participants, saving them an estimated $ 6 billion in discounted prescription drugs. These savings enable them to purchase the drugs for a price that is "at least 23.1 percent below the average manufacturer price (AMP) for brand name drugs, 13 percent below AMP for generic drugs; and 17.1 percent below AMP for clotting and pediatric drugs". These savings enable participants to provide more direct health care services to underserved populations. In recent years
1180-493: The National Vaccine Injury Compensation Program provides compensation to people who are found to be injured or killed by certain vaccines, or who have experienced certain medical events within a certain time of receiving such vaccines, irrespective of proof of causation. Established by PREP Act , in the case of pandemic, epidemic, or other major security threat requiring a medical countermeasure ,
1239-602: The Office of the Assistant Secretary for Health in 1989. In 1992, the Alcohol, Drug Abuse, and Mental Health Administration was abolished, with its three institutes and their research programs moved into NIH, and their treatment functions split off to form the new Substance Abuse and Mental Health Services Administration . Key: National Vaccine Injury Compensation Program The Office of Special Masters of
SECTION 20
#17328952983101298-415: The U.S. Fifth Circuit Court of Appeals ruled that plaintiffs suing three manufacturers of thimerosal could bypass the vaccine court and litigate in either state or federal court using the ordinary channels for recovery in tort . This was the first instance where a federal appeals court has held that a suit of this nature may bypass the vaccine court. The argument was that thimerosal is a preservative, not
1357-435: The hepatitis B vaccine causes Guillain–Barré syndrome , chronic demyelinating polyneuropathy, and multiple sclerosis . In the most extreme of these cases, a 2006 petitioner successfully claimed that a hepatitis B vaccine caused her multiple sclerosis despite several studies showing that the vaccine neither causes nor worsens the disease, and despite a conclusion by the Institute of Medicine that evidence favors rejection of
1416-593: The CICP provides compensation to eligible individuals for serious physical injuries or death. Examples include: United States Public Health Service reorganizations of 1966%E2%80%931973 Between 1966 and 1973, a series of reorganizations occurred of the United States Public Health Service (PHS) within the Department of Health, Education and Welfare (HEW). The reorganization by 1968 replaced PHS's old bureau structure with two new operating agencies:
1475-618: The Communicable Disease Center became the National Communicable Disease Center, and several divisions relating to environmental and occupational health were merged into the National Center for Urban and Industrial Health. However, this system would be short-lived as a more radical reorganization was carried out in 1968. The purpose of the 1968 reorganization was to create agencies that could coordinate
1534-808: The Community Health Service and the Health Facilities Planning and Construction Service from the recently abolished Health Services and Mental Health Administration (HSMHA). It became the Office of Special Programs in 1997 and the Healthcare Systems Bureau in 2004. HRSA oversees the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients in addition to promoting national awareness of
1593-693: The MMR vaccine and autism. Many studies have failed to conclude that there is a causal link between autism spectrum disorders and vaccines, and the current scientific consensus is that routine childhood vaccines are not linked to the development of autism . Several claimants have attempted to bypass the VICP process with claims that thimerosal in vaccines had caused autism, but these were ultimately not successful. They have demanded medical monitoring for vaccinated children who do not show signs of autism and have filed class-action suits on behalf of parents. In March 2006,
1652-509: The National Institute of Mental Health as well as the recently created National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse . By the end of 1973, PHS had the following operating agencies: This overall organizational structure has not substantially changed as of 2021, although there have been a few new operating agencies and minor reorganizations, the most recent of which occurred in 1992. In 1980,
1711-561: The National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines. The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine. Several U.S. lawsuits against vaccine makers won substantial awards. Most makers ceased production, and the last remaining major manufacturer threatened to do so. The VICP uses
1770-848: The Office of Pharmacy Affairs, resulted from enactment of Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act . Section 340B limits the cost of covered outpatient drugs to more than 18,000 eligible entities including ten types of health care providers and programs funded by the Health Resources and Services Administration (HRSA) and hospitals that provide care to high volumes of patients that are either indigent or located in remote areas. These hospitals include disproportionate share hospitals , children's hospitals , sole community hospitals, rural referral centers, critical access hospitals, and cancer hospitals exempt from
1829-477: The PHS earlier in 1970, causing CPEHS to be briefly renamed simply the Environmental Health Service . On the other hand, the entire National Air Pollution Control Administration was moved to EPA. The Environmental Control Administration's five bureaus were spit between PHS and EPA. PHS retained the Bureau of Occupational Safety and Health, which moved into HSMHA and soon became NIOSH ; part of
Healthcare Systems Bureau - Misplaced Pages Continue
1888-455: The PHS, and absorbed NIOSH. The remaining functions of HSMHA were assigned to newly established Health Services Administration and Health Resources Administration, the latter of which also acquired the Bureau of Health Manpower from NIH. Finally, under the HEW reorganization order of September 25, 1973, a new operating agency, the Alcohol, Drug Abuse, and Mental Health Administration , incorporated
1947-408: The U.S. Court of Federal Claims , popularly known as " vaccine court ", administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims , sitting without a jury. The National Vaccine Injury Compensation Program ( VICP or NVICP )
2006-415: The VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury". Cases are settled to minimize the risk of loss for both parties, to minimize the time and expense of litigation, and to resolve petitions quickly. Of the remaining cases, in the vaccine court, as in civil tort cases,
2065-403: The VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury". Cases are settled to minimize the risk of loss for both parties, to minimize the time and expense of litigation, and to resolve petitions quickly. The U.S. Department of Health and Human Services set up
2124-545: The VICP. Of these claims, 925 (see previous rulings ), were compensated, with 1,158 non-autism and 350 autism claims dismissed, and one autism-like claim compensated; awards (including attorney's fees) totaled $ 847 million. The VICP also applies to claims for injuries suffered before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $ 903 million. As of October 2019, $ 4.2 billion in compensation (not including attorneys fees and costs) has been awarded. As of December 2020 , filing
2183-568: The Vaccine Injury Table maintained by the Secretary of Health and Human Services; in 2007 the list included vaccines against diphtheria , tetanus , pertussis (whooping cough), measles , mumps , rubella (German measles), polio , hepatitis B , varicella (chicken pox), Haemophilus influenzae type b , rotavirus , and pneumonia . From 1988 until January 8, 2008, 5,263 claims relating to autism, and 2,865 non-autism claims, were made to
2242-635: The agencies they were stationed in than to the Corps itself. By the end of 1968, PHS's operating divisions were the National Institutes of Health, HSMHA, and CPEHS, the last two of which were organized as follows: The breakup of CPEHS was largely a consequence of the formation of the Environmental Protection Agency (EPA) in 1970, as the result of a desire by the new Nixon administration to gather all federal environmental activities into
2301-415: The average claim took two years to resolve, and 42% of resolved claims were awarded compensation, as compared with 23% for medical malpractice claims through the tort system. There is a three-year statute of limitations for filing a claim, timed from the first manifestation of the medical problem. More than 5,300 petitions alleging autism caused by vaccines have been filed in the vaccine court. In 2002,
2360-495: The beginning of the Nixon Administration in 1969. HSMHA was reportedly referred to as "HSMA-ha-ha-ha" at NCDC headquarters, and Sencer was seeking to expand NCDC's scope by absorbing other components of HSMHA. As part of this, NCDC was renamed to Center for Disease Control in 1970. Under the HEW reorganization order of July 1, 1973, HSMHA was abolished. The Center for Disease Control became its own operating agency within
2419-525: The burden of proof is a preponderance of evidence , but while in tort cases this is met by expert testimony based on epidemiology or rigorous scientific studies showing both general and specific causation, in the vaccine court, the burden is met with a three prong test established in Althen , a 2005 United States Court of Appeals for the Federal Circuit ruling. Althen held that an award should be granted if
Healthcare Systems Bureau - Misplaced Pages Continue
2478-462: The case was settled without proof of causation. With the commencement of hearings in the case of Cedillo v. Secretary of Health and Human Services (Case #98-916V), the argument over whether autism is a vaccine injury moved into the vaccine court. A panel of three special masters began hearing the first cases of the historic Omnibus Autism Proceedings in June 2007. There were six test cases in all, and
2537-442: The court instituted the Omnibus Autism Proceeding in which plaintiffs were allowed to proceed with the three cases they considered to be the strongest before a panel of special masters. In each of the cases, the panel found that the plaintiffs had failed to demonstrate a causal effect between the MMR vaccine and autism. Following this determination, the vaccine court has routinely dismissed such suits, finding no causal effect between
2596-567: The critical need for organ and tissue donation. HRSA also provides staff and logistics support to the Advisory Committee on Organ Transplantation, which makes recommendations to the Secretary of the U.S. Department of Health and Human Services on issues concerning organ donation and transplantation. Under the C.W. Bill Young Cell Transplantation Program and National Cord Blood Inventory, HRSA helps make possible blood stem cell transplants for patients with life-threatening blood disorders who lack
2655-440: The entire record of the cases is publicly available. The lead petitioners, the parents of Michelle Cedillo, claimed that Michelle's autism was caused by a vaccine. Theresa and Michael Cedillo contended that thimerosal seriously weakened Michelle's immune system and prevented her body from clearing the measles virus after her vaccination at the age of fifteen months. At the outset Special Master George Hastings, Jr. said "Clearly
2714-459: The loss of herd immunity . Between its inception in 1986 and May 2023, it has awarded a total of $ 4.6 billion, with the average award amount between 2006 and 2020 being $ 450,000, and the award rate (which varies by vaccine) being 1.2 awards per million doses administered. The Health Resources and Services Administration reported in July 2022 that "approximately 60 percent of all compensation awarded by
2773-401: The national toll-free poison help line, 1-800-222-1222. 340B Drug Program is applicable to hospitals (mixed-use and outpatient clinics) and contract pharmacies. The 340B Program is often managed by software for maximizing the savings and for providing compliance. 340BSoftware.com is an example of such software. The Program is a federal program. The 340B Drug Pricing Program , administered by
2832-492: The operating divisions was accomplished during 1966–1968 in two waves. An initial reorganization into a five-bureau structure was accomplished in 1967. The new bureau system was oriented around "national centers", with larger divisions simply being renamed, and smaller divisions being combined as programs within the national centers. For example, the Division of Radiological Health became the National Center for Radiological Health,
2891-592: The paper is being published..." The resulting organizations came to be seen as large and unwieldy. Another effect of the reorganizations was the creation of the position of Assistant Secretary for Health , a political appointee who supplanted the Surgeon General as the head of the PHS. This was seen as undermining the chain of command of the PHS Commissioned Corps , beginning a long-term shift where Commissioned Corps officers were more responsible to
2950-423: The petitioner. This is "to ensure that vaccine claimants have readily available a competent bar to prosecute their claims". The Homeland Security Act of 2002 provides another exception to the exclusive jurisdiction of the vaccine court. If smallpox vaccine were to be widely administered by public health authorities in response to a terrorist or other biological warfare attack, persons administering or producing
3009-579: The program has seen a 3-4% annual growth rate. Pharmaceuticals purchased at 340B pricing account for 2% of drugs purchased in the U.S. annually. The Hill-Burton Program requires 200 obligated health care facilities to provide free or reduced cost health care to patients who are uninsured, unable to pay, and unqualified for Medicaid coverage. In exchange for such services, the program previously funded grants and loans for new construction and improvements to 6,800 facilities nationwide. But most of those locations have discharged their obligations and no longer are in
SECTION 50
#17328952983103068-532: The program. Since 1980, almost $ 6 billion in uncompensated Hill-Burton services have been provided. In FY 2008, HRSA monitored 940 projects worth $ 691 million for health care and health-related facilities to meet their design, construction and equipment needs. Congress designates each of the awardees on an individual basis. Most people who get vaccines have no serious problems. However, vaccines, like any medicines, can cause serious problems — such as severe allergic reactions — on certain rare occasions. In those cases,
3127-401: The relationships between divisions with similar focus, providing a holistic rather than fragmented approach. HSMHA in particular was created with the recognition that, with the recent creation of Medicare and Medicaid increasing financing of healthcare, increased demand was straining healthcare delivery resources. CPEHS stemmed from a belief that environmental health concerned not only
3186-480: The story of Michelle's life is a tragic one," while pledging to listen carefully to the evidence. On February 12, 2009, the court ruled in three test cases that the combination of the MMR vaccine and thimerosal-containing vaccines were not to blame for autism. Hastings concluded in his decision, "Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment." The ruling
3245-499: The vaccine would be deemed federal employees and claims would be subject to the Federal Tort Claims Act , in which case claimants would sue the U.S. Government in the U.S. district courts, and would have the burden of proving the defendants' negligence, a much more difficult standard. Notably, the Health Resources and Services Administration reported in July 2022 that "approximately 60 percent of all compensation awarded by
3304-482: The years 2006-2017. This shows that on average 1.2 awards were made per million vaccine doses. It also shows that multiple vaccines such as MMR do not have an abnormal award rate. * This covers the vaccinations known by the abbreviations DT, DTaP, DTaP-HIB, DTaP-IPV, DTap-IPV-HIB, Td, Tdap Self representation is permitted, although the NVICP also pays attorneys fees out of the fund, separate from any compensation given to
3363-654: Was already an operating agency; the Division of Indian Health and Division of Hospitals were part of BMS; the National Communicable Disease Center , Division of Occupational Health , and National Center for Radiological Health were all part of BSS's Environmental Health Divisions; and the National Center for Health Statistics was part of OSG. The Food and Drug Administration was part of HEW, but not yet part of PHS. The initial reorganizations of
3422-438: Was broken up in 1970, as most of it was transferred out of PHS to form the core of the new Environmental Protection Agency . HSMHA was broken up in 1973. This left PHS with six operating agencies, a configuration substantially similar to the current one as of 2021. In all, PHS had at least eight discrete reorganizations in as many years. The quick succession of reorganizations created several operating agencies that existed for
3481-531: Was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine . Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared
#309690