Healthcare Systems Bureau

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The Healthcare Systems Bureau is part of the Health Resources and Services Administration (HRSA), of the United States Department of Health and Human Services.

Contents

Overview

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.

Key facts

History

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 the Community Health Service and the Health Facilities Planning and Construction Service from the recently abolished Health Services and Mental Health Administration (HSMHA). [1] It became the Office of Special Programs in 1997 [2] and the Healthcare Systems Bureau in 2004. [3]

Activities

Transplantation

HRSA oversees the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients in addition to promoting national awareness of 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 a related donor. [4] 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.

Poison Control Program

HRSA awards grants to the nation's 61 poison control centers and manages the national toll-free poison help line, 1-800-222-1222.

340B Drug Pricing Program

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 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 the Medicare prospective payment system. [5]

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. [6] 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". [7] These savings enable participants to provide more direct health care services to underserved populations. In recent years the program has seen a 3-4% annual growth rate. [6]

Pharmaceuticals purchased at 340B pricing account for 2% of drugs purchased in the U.S. annually. [6]

Hill-Burton Program

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 the program. Since 1980, almost $6 billion in uncompensated Hill-Burton services have been provided.

Healthcare and other facilities

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.

Compensation programs

National Vaccine Injury Compensation Program (VICP)

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, 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.

Countermeasures Injury Compensation Program

Established by PREP Act, [8] in the case of pandemic, epidemic, or other major security threat requiring a medical countermeasure, the CICP provides compensation to eligible individuals for serious physical injuries or death. [9] Examples include: [10] [11] [12]

Related Research Articles

The Bureau of Primary Health Care (BPHC) is a part of the Health Resources and Services Administration (HRSA), of the United States Department of Health and Human Services. HRSA helps fund, staff and support a national network of health clinics for people who otherwise would have little or no access to care. BPHC funds health centers in underserved communities, providing access to high quality, family oriented, comprehensive primary and preventive health care for people who are low-income, uninsured or face other obstacles to getting health care.

A cord blood bank is a facility which stores umbilical cord blood for future use. Both private and public cord blood banks have developed in response to the potential for cord blood in treating diseases of the blood and immune systems. Public cord blood banks accept donations to be used for anyone in need, and as such function like public blood banks. Traditionally, public cord blood banking has been more widely accepted by the medical community. Private cord blood banks store cord blood solely for potential use by the donor or donor's family. Private banks typically charge around $2,000 for the collection and around $200 a year for storage.

<span class="mw-page-title-main">Health Resources and Services Administration</span> United States government agency

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<span class="mw-page-title-main">Canadian Blood Services</span>

Canadian Blood Services is a non-profit charitable organization that is independent from the Canadian government. The Canadian Blood Services was established as Canada's blood authority in all provinces and territories except for Quebec in 1998. The federal, provincial and territorial governments created the Canadian Blood Services through a memorandum of understanding. Canadian Blood Services is funded mainly through the provincial and territorial governments.

Eye banks recover, prepare and deliver donated eyes for cornea transplants and research. The first successful cornea transplant was performed in 1905 and the first eye bank was founded in 1944. Currently, in the United States, eye banks provide tissue for over 80,000 cornea transplants each year to treat conditions such as keratoconus and corneal scarring. In some cases, the white of the eye (sclera) is used to surgically repair recipient eyes. Unlike other organs and tissues, corneas are in adequate supply for transplants in the United States, and excess tissue is exported internationally, where there are shortages in many countries, due to greater demand and a less-developed eye banking infrastructure.

<span class="mw-page-title-main">National Childhood Vaccine Injury Act</span> US law

The National Childhood Vaccine Injury Act (NCVIA) of 1986 was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. The World Health Organization (WHO) knows VAEs as Adverse Events Following Immunization (AEFI).

<span class="mw-page-title-main">M Health Fairview University of Minnesota Medical Center</span> Hospital in Minneapolis, Minnesota, US

M Health Fairview University of Minnesota Medical Center (UMMC) previously known as University of Minnesota Medical Center, is a 1700-bed non-profit, tertiary, research and academic medical center located in Minneapolis, Minnesota, servicing the entire region. UMMC is the region's only university-level academic medical center. The hospital is operated by the M Health Fairview Health System and the largest hospital in the system. UMMC is affiliated with the University of Minnesota Medical School. UMMC is also an ACS designated level II trauma center and has a rooftop helipad to handle medevac patients. Attached to the medical center is the Masonic Children's Hospital that treats infants, children, adolescents, and young adults up to the age of 21.

<span class="mw-page-title-main">United Network for Organ Sharing</span>

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<span class="mw-page-title-main">National Organ Transplant Act of 1984</span>

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<span class="mw-page-title-main">NYU Langone Health</span> Hospital in New York, United States

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<span class="mw-page-title-main">Gift of Life Marrow Registry</span> Public bone marrow and blood stem cell registry

The Gift of Life Marrow Registry is a public bone marrow and blood stem cell registry headquartered in Boca Raton, Florida. Gift of Life facilitates transplants for children and adults suffering from life-threatening illnesses, including leukemia, lymphoma, other cancers and genetic diseases.

The FDA Adverse Event Reporting System is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery. The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012.

The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The intent of the program is to allow covered entities to "stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services." Maintaining services and lowering medication costs for patients is consistent with the purpose of the program, which is named for the section authorizing it in the Public Health Service Act (PHSA) It was enacted by Congress as part of a larger bill signed into law by President George H. W. Bush.

References

  1. "Records of the Health Resources and Services Administration [HRSA]". National Archives. 2016-08-15. Section 512.3. Retrieved 2020-08-29.
  2. 62 FR 43173
  3. 69 FR 56433
  4. science of biogenetics (11 February 2017). "What you must know about umbilical cord stem cells".
  5. U.S. Government Accountability Office, Report to Committees: Drug Pricing (GAO-11-836), September 2011.
  6. 1 2 3 U.S. Department of Health and Human Services, Health Resources and Services Administration, Fiscal Year 2014 Justifications for Estimates for Appropriation Committees.
  7. U.S. Department of Health and Human Services, Health Resources and Services Administration, Fiscal Year 2014 Justifications for Estimates for Appropriation Committees, page 310.
  8. "Public Readiness and Emergency Preparedness (PREP) Act". Archived from the original on December 21, 2021.
  9. "About CICP". Archived from the original on December 26, 2021.
  10. "Examples of covered public health threats" (PDF). Archived from the original (PDF) on December 21, 2021.
  11. "Covered Countermeasures". Archived from the original on December 26, 2021.
  12. "Covered Countermeasures". Archived from the original on September 25, 2020.