Physician Workforce Diversity by Race and Ethnicity

Published: Jul 22, 2025

Introduction

Racial and ethnic disparities in health outcomes remain persistent in the United States, driven by inequitable access to and utilization of health care services and broader social and economic factors that reflect historical and ongoing racism. One factor that can mitigate these disparities is racial concordance between physicians and patients, that is, when providers and patients share the same racial or ethnic background. Research suggests that patient and provider racial concordance may be linked to increased visits for preventative care, greater treatment adherence, and lower emergency department use. One study found that greater representation of Black primary care physicians was associated with increased life expectancy and lower mortality among Black people. KFF 2023 survey data show Black, Hispanic, and Asian adults who have more health care visits with providers who share their racial and ethnic background more frequently report having positive and respectful interactions. Despite these benefits, many people of color face challenges accessing racially concordant providers. KFF survey data show that most Hispanic, Black, Asian, and American Indian and Alaska Native (AIAN) adults say that fewer than half of their health care visits in the past three years were with a provider who shared their racial or ethnic background. While data show that adults of color are more likely than White adults to prefer a provider of the same race or ethnicity, they are significantly less likely to have one and are more likely to have difficulty finding one.

Recent policy changes may exacerbate challenges to obtaining racially concordant care for those who value it most. In 2023, the U.S. Supreme Court effectively ended race-conscious admissions in higher education, overturning decades of precedent supporting affirmative action. Additionally, as one of his initial actions in office, President Trump issued executive orders eliminating federal diversity, equity, inclusion, and accessibility (DEIA) related programs and actions in the federal government and among federal contractors and grantees. These actions may reduce matriculation rates for students of color and reverse progress in diversifying the health care workforce to reflect the population it serves. For instance, research indicates that the Supreme Court’s 2023 ruling has already led to a decline in the number of Black, Hispanic, and AIAN students entering medical school. Among Black, Hispanic, AIAN, and Native Hawaiian and Pacific Islander (NHPI) medical school enrollees, there was a decline in matriculants between 2023 and 2024. Despite there being more Black and Hispanic applicants in 2024 compared to the previous year, the number of matriculants from historically underrepresented groups declined. It’s unclear how much impact the Supreme Court ruling has already had on medical school matriculation. However, the ruling has the potential to further decrease the diversity of the future physician workforce.

This brief provides an overview of the racial and ethnic composition of physicians compared to the total population at the national and state level based on KFF analysis of 2023 Association of American Medical Colleges (AAMC) Physician Workforce data and American Community Survey data. This analysis shows that Hispanic, Black, AIAN, and NHPI people were underrepresented among physicians relative to their share of the population, with the widest gap observed among Hispanic people who comprised 20% of the total population but only 7% of the total physician workforce. The pattern of underrepresentation held true across most states for Hispanic and Black people, with particularly large gaps for Hispanic people. Asian people accounted for a higher share of physicians than their share of the total population nationally and in all states; in most states, the share of White physicians was similar to or higher than their share of the total population. Data were not available for AIAN and NHPI populations in many states due to small numbers.

Racial and Ethnic Distribution of Physicians

Nationally, Hispanic, Black, AIAN, and NHPI people were underrepresented among physicians relative to their share of the population with the widest gap observed among Hispanic people. While one in five people in the U.S. population was Hispanic, they accounted for just 7% of the physician workforce (Figure 1). Similarly, 12% of the population was Black compared to 6% of the physician workforce. AIAN and NHPI individuals were also underrepresented among physicians compared to their share of the overall population. However, the absolute differences were small, as both groups make up less than one percent of the total population and the physician workforce. In contrast, White people accounted for similar shares of the total population and physician workforce, and Asian people accounted for a larger share of physicians (19%) than their share of the population (6%).

Distribution of People by Race and Ethnicity in the Total Population and Physician Workforce

Across most states, Hispanic and Black people made up a smaller share of physicians compared to their share of the total population, with particularly large gaps for Hispanic people. In 45 states and DC, Hispanic people accounted for a smaller share of providers than their share of the population, as measured by a more than one percentage point difference (Figure 2). In seven states, the difference between the share of the population and providers who are Hispanic was over 15 percentage points. These tended to be states with the highest shares of Hispanic people, including New Mexico, California, and Texas. In New Mexico, Hispanic people made up nearly half (48%) the population but accounted for 17% of providers (a difference of 31 percentage points). In California and Texas, about 40% of the population was Hispanic compared to 7% and 13% of physicians, respectively. In only five states (West Virginia, Vermont, Maine, Mississippi, and Ohio) did Hispanic people account for a similar share of the population and the physician workforce, with a difference of less than one percentage point.

The Hispanic Population Was Most Underrepresented Among Physicians in the West and Southwest

Similarly, in 35 of 50 states and DC, Black people made up a smaller share of physicians compared to their share of the population. In five states and DC, the difference between the share of the population and providers who are Black was 15 percentage points or higher, with the largest gap of 26 percentage points in DC and Mississippi (Figure 3). In DC, 17% of providers were Black compared with 43% of the population, and in Mississippi, Black people made up 11% of physicians compared with 37% of the population.

The Black Population Was Most Underrepresented Among Physicians in the Southeast

Data were insufficient for comparisons for AIAN and NHPI people in most states, but where data were available, AIAN and NHPI people were underrepresented among physicians relative to their share of the population. This pattern was most prominent in states where the majority of AIAN and NHPI people live. For example, In Alaska, AIAN people accounted for 14% of the population, seven times higher than their share of physicians (2%). Additionally, in New Mexico, AIAN people made up 9% of the population compared to 2% of providers, and in South Dakota they comprised 7% of the population compared with 1% of providers. Similarly, in Hawaii, NHPI people made up 10% of the population compared to 2% of physicians. In most remaining states, AIAN and NHPI people accounted for both a small share of the population and providers, so absolute differences in their shares were small.

Asian people accounted for a higher share of physicians than their share of the total population in all states. The largest differences were in Illinois, California, Delaware, and Texas. In Illinois, Asian people made up more than one in four physicians but accounted for only about 5% of the population (Figure 4). There were sizeable differences in the states with the highest shares of Asian people. In Hawaii, 37% of the population was Asian compared with 43% of providers, and in California, 15% of the population was Asian versus 32% of providers. The differences were smaller in other states, like Alaska, Montana, and Vermont, where Asian people accounted for a small share of both providers and the population.

The Asian Population Was Broadly Overrepresented Among Physicians in All States

In most states, the share of White physicians was similar to or higher than their share of the total population. States where White people were most underrepresented among physicians compared to their share of the population included West Virginia (67% vs. 90%), North Dakota (67% vs. 83%), and Michigan (58% vs. 73%) (Figure 5). The pattern in these states reflected higher representation of Asian people among physicians. States where White people were most overrepresented among physicians compared to their share of the population included New Mexico (56% vs. 37%), Alaska (77% vs. 58%), and Mississippi (70% vs. 55%).

The White Population Was Most Overrepresented Among Physicians in the Midwest

A similar pattern was observed across medical specialties, with Hispanic and Black individuals underrepresented in more specialties than other racial and ethnic groups. Specialties providing primary care—such as family medicine, pediatrics, and obstetrics/gynecology—tended to better reflect the racial and ethnic distribution of the population. Among all specialties, providers in nephrology and interventional cardiology had the least racial and ethnic representation compared to the national population. The Hispanic population was the most underrepresented group in more than half of the specialties analyzed (27 out of 51 specialties). The Black population was the most underrepresented group in 9 out of 51 specialties.

Methods

KFF collected U.S. Physician Workforce data from the Association of American Medical Colleges (AAMC) from the dashboard for 2023, aggregated by specialty and location. Although race/ethnicity data were provided as “alone or in combination,” categories were treated as exclusive in the analysis since a “multiracial” option was provided. Respondents with unknown race/ethnicity were proportionally distributed within each state to all other categories. Due to values being masked due to small cell sizes, only the Asian, Black, Hispanic, and White categories were used in the provider specialty analysis, where only specialties with more than 5,000 active physicians were included. For comparison to the population at large, 5-year estimates from the 2023 American Community Survey were used to determine the racial and ethnic distribution of the total population for each state, using single-response values for not Hispanic or Latino, and any response for Hispanic or Latino. To determine how well the active physician population matches the national population for each specialty, an index of dissimilarity was used, proportional to the total percentage point difference in the race/ethnicity share of providers and the country overall. To assess the robustness of this method, Kullback–Leibler divergence was calculated for each specialty, a measure of statistical distance between the race/ethnicity distribution among physicians and that of the national population. Rank order among the specialties was similar for both methods.

News Release

Victoria DeFrancesco Soto Joins KFF Board of Trustees

Published: Jul 21, 2025

San Francisco – KFF announced today that Dr. Victoria DeFrancesco Soto has joined KFF’s Board of Trustees. DeFrancesco Soto is the Dean of the Clinton School of Public Service at the University of Arkansas and previously served as Assistant Dean at the LBJ School of Public Affairs at the University of Texas at Austin. She has served as a trusted voice of political analysis for NBC News and Telemundo.

“It is my honor to serve on the KFF board,” said DeFrancesco Soto. “As an educator I am passionate about making research tangible to our day-to-day lives. KFF is a national model for translating the power of data and research into action. I am excited to roll up my sleeves and deeply engage in the impactful work of KFF.”

“Victoria’s deep knowledge of politics, policy, and media is a perfect fit for KFF, and we will benefit tremendously from her expertise and experience as we continue to expand our role as health care’s independent source of policy analysis, polling, and journalism,” said Dr. Drew Altman, President and CEO.

Dr. DeFrancesco Soto is the first Latina Dean at a presidential institution and is a fellow of the National Academy of Public Administration. She previously taught at Northwestern University and Rutgers and received her Ph.D. in political science from Duke University.

Her areas of expertise include civic engagement, women, immigration, Latinos and political psychology. Underlying all of her research interests is the applicability of high-quality, rigorous research to on-the-ground policy realities. 

KFF’s Board of Trustees is chaired by former U.S. Senator Olympia Snowe and its members have deep backgrounds in public service, academia, nonprofit organizations, health care, and the media.

Board members serve up to two, five-year terms. Additional information about KFF’s board can be found at https://www.kff.org/board-of-trustees/.

New Policy Bars Many Lawfully Present and Undocumented Immigrants from a Broad Range of Federal Health and Social Supports

Published: Jul 21, 2025

Editorial Note

This content was updated on September 9, 2025, to include changes to the implementation date of the policy following court orders.

On July 14, 2025, the U.S. Department of Health and Human Services (HHS) issued a notice of a policy change to update the definition of “federal public benefits” as outlined in the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) to add an additional 13 programs to the 31 programs considered “federal public benefits” that are restricted to individuals with a “qualified” immigration status. The notice further indicates that the updated list of federal benefits is not exhaustive, and additional programs may be added in the future. This change bars many groups of lawfully present immigrants as well as undocumented immigrants from accessing many health care, educational, and other social services and will likely have negative impacts on the health and well-being of immigrant families due to more limited access to services as well as confusion and fear about using services. It also may create new challenges and complexities for service providers. Many implementation questions remain unclear and subject to future guidance, including how verification of immigration status may occur and how the policy will be reconciled with existing conflicting statutory and regulatory requirements, which supersede the guidance. This policy change was expected to take effect immediately upon publication of the notice in the federal register on July 14, 2025, although it provided for a 30-day comment period. However, the HHS has agreed to delay implementation until September 11, 2025, following court orders.

Prior Policy under PRWORA

When enacted in 1996, PRWORA established federal requirements that limited eligibility for “federal public benefits” to groups who are “qualified immigrants.” The groups defined as “qualified immigrants” are more limited than groups who are considered lawfully present in the U.S. and exclude undocumented immigrants. Notably, qualified immigrants do not include people with Temporary Protected Status and people with deferred action, including Deferred Action for Childhood Arrivals recipients, among other lawfully present groups (Box 1).

Box 1: Lawfully Present Immigrants by Qualified Status

Qualified Immigrants

Other Lawfully Present Immigrants

  • Lawful permanent resident (LPR or green card holder)
  • Refugee
  • Asylee
  • Cuban/Haitian entrant
  • Paroled into the U.S. for at least one year
  • Conditional entrant granted before 1980
  • Granted withholding of deportation
  • Battered noncitizen, spouse, child, or parent
  • Victims of trafficking and their spouse, child, sibling, or parent or individuals with pending application for a victim of trafficking visa
  • Member of a federally recognized Indian tribe or American Indian born in Canada
  • Citizens of the Marshall Islands, Micronesia, and Palau who are living in one of the U.S. states or territories (referred to as Compact of Free Association or COFA migrants)
  • Granted Withholding of Deportation or Withholding of Removal, under the immigration laws or under the Convention against Torture (CAT)
  • Individual with Non-Immigrant Status, includes workers visas, student visas, U-visa, and other visas, and citizens of Micronesia, the Marshall Islands, and Palau
  • Temporary Protected Status (TPS)
  • Deferred Enforced Departure (DED)
  • Deferred Action Status
  • Lawful Temporary Resident
  • Administrative order staying removal issued by the Department of Homeland Security
  • Resident of American Samoa
  • Applicants for certain statuses
  • People with certain statuses who have employment authorization

The PROWRA legislation provided discretion to federal agencies to determine which benefits and programs are “federal public benefits,” while also identifying specific exemptions such as treatment for emergency medical conditions, certain disaster relief, immunizations, and testing and treatment for communicable diseases. It also clarified that non-profit organizations were not required to verify the immigration status of individuals receiving benefits or services. Under policy established in 1998, HHS identified 31 health and social programs considered to be “federal public benefits” restricted to “qualified immigrants,” including major health coverage programs such as Medicaid (excluding emergency Medicaid), Medicare, and the Children’s Health Insurance Program (CHIP).

Changes under the 2025 Policy

The 2025 policy expands the list of programs considered “federal public benefits” by adding 13 additional programs, including Head Start, the health center program, the Title X family planning program, among others (Box 2). The notice further indicates that the list is not exhaustive, and additional programs may be added to in the future.

Box 2: New Programs Considered “Federal Public Benefits” Under the 2025 Policy Change

  • Certified Community Behavioral Health Clinics
  • Community Mental Health Services Block Grant
  • Community Services Block Grant (CSBG)
  • Head Start
  • Health Center Program
  • Health Workforce Programs not otherwise previously covered (including grants, loans, scholarships, payments, and loan repayments)
  • Mental Health and Substance Use Disorder Treatment, Prevention, and Recovery Support Services Programs administered by the Substance Abuse and Mental Health Services Administration
  • Projects for Assistance in Transition from Homelessness Grant Program
  • Substance Use Prevention, Treatment, and Recovery Services Block Grant
  • Title IV-E Educational and Training Voucher Program
  • Title IV-E Kinship Guardianship Assistance Program
  • Title IV-E Prevention Services Program
  • Title X Family Planning Program
  • List is not exhaustive and may be added to in the future

Source: U.S. Department of Health and Human Services (July 2025), “HHS Bans Illegal Aliens from Accessing its Taxpayer-Funded Programs

Implications of the Policy Change

The policy change bars many lawfully present and undocumented immigrants from services that are important for their health and well-being. These programs include certain programs that are particularly important for immigrant families, such as the federal Health Center program, which funds a network of Community Health Centers (CHCs). Community health centers are a national network of over 1,300 safety-net primary care providers located in medically underserved communities and serve all patients regardless of their ability to pay, providing a range of medical, behavioral, and supportive services. Data from the 2023 KFF/LA Times Survey of Immigrants show that three in ten immigrant adults say a CHC is their usual source of care, with this share rising to about four in ten among likely undocumented immigrant adults (42%) and those with limited English proficiency (39%) (Figure 1). The policy also bars immigrants without a “qualified” immigration status from accessing federally funded mental and behavioral health services at a time when many immigrant families are experiencing heightened stress and anxiety due to immigration-related fears and financial uncertainty, as well as from Title X services, which provide comprehensive family planning services to low-income and uninsured individuals.

Three in Ten Immigrant Adults Say That  Community Health Centers are Their Usual Source of Care

Beyond health care, the policy also limits access to services that support education, including the Head Start Program. Research shows that adults with higher educational attainment tend to have longer lifespans and be healthier than their counterparts with lower educational attainment. High educational attainment also is associated with better jobs that are more likely to provide employer-sponsored health coverage and higher incomes which, in turn, improve access to health care and resources to support health.

The new policy also will affect service providers who may need to update their policies and procedures to comply with the changes. Under PRWORA, program benefit providers are prohibited from providing “federal public benefits” to people who are not citizens or qualified immigrants and are required to verify that an applicant is a qualified immigrant eligible for services. The notice confirms an existing exemption in the law that non-profit charitable organizations are not required to verify immigration status. However, many implementation questions currently remain unclear and subject to future guidance, including how verification of immigration status may occur. Moreover, the policy does not supersede existing statutory and regulatory requirements. For example, although the notice limits the health center program to “qualified immigrants,” it does not change the underlying statutory requirements for CHCs to serve patients regardless of immigration status. While federal law supersedes guidance, this conflict creates challenges for CHCs in how they will apply this guidance, and it remains to be seen how enforcement of the guidance will affect CHCs’ ability to provide care. Additionally, as noted, the notice indicates that the list of programs affected by the change is not exhaustive, so additional programs may be added in the future.

The notice estimates that the policy change will result in savings from reduced use of programs by certain immigrants as well as new administrative costs. Savings are estimated to derive from excluding certain immigrants from HHS programs with a corresponding increase in benefits for U.S. citizens and qualified immigrants. There also are estimated to be new administrative costs associated with individuals being required to document their eligibility, for immigration status to be verified, and for changes in program eligibility and operating policies and procedures.

The policy change occurs against a backdrop of other policy changes restricting immigrant access to health and other programs and increased immigration enforcement activity. These changes include new restrictions established under budget reconciliation that limit Medicaid, Medicare, and subsidized Affordable Care Act (ACA) Marketplace coverage to lawful permanent residents, certain Cuban and Haitian entrants, and citizens of the Freely Associated States (COFA migrants). Together, these changes will likely have broad chilling effects on immigrant families, resulting in increased reluctance to access services and programs due to fear and confusion. More limited access to programs and services may lead to negative impacts on their health and well-being. These effects may extend across immigrant families, who often include citizen children—with one in four children in the U.S. living with at least one immigrant parent—and have broader impacts on communities, given immigrants’ role in the workforce.

News Release

Insurers’ Preliminary Rate Filings Anticipate Biggest Increases in ACA Marketplace Plan Premiums Since 2018

Scheduled Expiration of Enhanced Tax Credits and Impact of Tariffs Among Factors Pushing Premiums Higher

Published: Jul 18, 2025

Note: For updated data on proposed ACA Marketplace premiums from more than 300 insurers in all 50 states and DC, read our updated analysis.

ACA Marketplace insurers are proposing a median premium increase of 15% for 2026, according to a new analysis of preliminary rate filings. Based on the early indications, individual market insurers will introduce the largest hike in premiums since 2018, the last time policy uncertainty contributed to sharp premium growth.

Across the 105 ACA Marketplace insurers in 19 states and DC that have submitted rate filings so far, most are requesting premium increases of 10% to 20% for 2026, and more than a quarter are proposing premium increases of 20% or more.

In addition to the anticipated growth in the cost of health care services, insurers have cited several policy changes that they expect to drive up rates next year, including the following:

  • The expiration of the enhanced premium tax credits at the end of this year, which have made coverage more affordable and contributed to record-high enrollment in the ACA Marketplaces, is expected to drive up out-of-pocket premium payments by more than 75% on average and cause many healthier enrollees to drop their coverage.
  • The impact of tariffs on some drugs, medical equipment, and supplies. Some insurers estimate that they could increase premiums by an average of 3% more than they otherwise would have.

Other factors could also affect premium changes, including the budget reconciliation legislation and Marketplace Integrity and Affordability rule, both of which were enacted and finalized after many of these insurers submitted their preliminary rate filings. Finalized 2026 rate changes are expected to be published in late summer.Subsidized enrollees are generally shielded from annual rate increases as their tax credits keep premium payments capped at a portion of their income.

However, with enhanced tax credits set to expire later this year if Congress takes no action to extend them, subsidized enrollees will pay more because they have less financial assistance. Middle income people with incomes above four times the poverty level would no longer be eligible for assistance and would have to shoulder the full premium.

The full analysis and other data on health costs are available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.

Individual Market Insurers Requesting Largest Premium Increases in More Than 5 Years

Published: Jul 18, 2025

Note: For updated data on ACA Marketplace premiums from more than 300 insurers in all 50 states and DC, read our updated analysis.

This analysis of preliminary rate filings submitted by 105 ACA Marketplace insurers in 19 states and DC finds that ACA Marketplace insurers are requesting a median premium increase of 15% for 2026, which would represent the largest hike in premiums since 2018, the last time policy uncertainty contributed to sharp premium growth.

In addition to the anticipated growth in the cost of health care services, insurers have cited several policy changes that they expect to drive up rates next year, including the expiration of the enhanced premium tax credits at the end of this year and the impact of tariffs on some drugs, medical equipment, and supplies.

The full analysis and other data on health costs are available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.

Impacts of Federal Actions on Extreme Heat and Health

Published: Jul 17, 2025

Introduction

Extreme heat continues to be a pressing issue as 2024 was recognized as the hottest year ever experienced, and 2025 is slated to be one of the five warmest years on record, with experts predicting more extreme heat records over the next five years. Warm seasons have lengthened, become more frequent, and increased in intensity due to climate change. In early July 2025, communities in Texas, New Mexico, and North Carolina experienced deadly flash floods, with over 100 people dying in the Texas floods. Flash floods are primarily a summertime weather event, the combination of high humidity levels, drought, and heat create favorable conditions for torrential downpours and flash flood events. More flash floods are expected to occur in the U.S. during summer 2025 and research finds that the risk of future flash flood events will increase as the climate warms.

In recent years, there have been rising incidents of extreme heat, poor air quality, drought, and wildfire events both globally and across the country. Exposure to extreme heat poses major health risks that disproportionately affect those with limited resources. Research shows that between 1999 and 2023, the number of heat-related deaths in the U.S. increased by 117%, from 1,069 heat-related deaths in 1999 to 2,325 in 2023. Moreover, KFF analysis of data from the Centers for Disease Control and Prevention shows that American Indian or Alaska Native and Black people are at higher risk of experiencing a heat-related death compared to their White counterparts. Estimates suggest that heat events in the U.S result in approximately $1 billion in excess health care costs each year. If left unaddressed, climate change could cost the U.S. economy approximately $14.5 trillion over the next fifty years.

Prior administrations and state and local governments increased efforts to address climate change, extreme heat, and their impacts on human health in recent decades. However, more recent efforts by the Trump administration have reversed some of these prior actions. Rollbacks in federal actions to address climate change-related inequities broadly and the impacts of extreme heat specifically, may contribute to worse health outcomes, disproportionately impacting many populations that already face disparities in health, including lower income populations, people of color, and immigrants. The elimination of key offices, programs, and data tools makes it more difficult to assess and mitigate the health risks associated with environmental hazards, including extreme heat. Beyond the federal administrative actions already taken, cuts to federal funding may further erode efforts to reduce heat exposure and its health-related impacts. Some states have taken steps to mitigate exposure to extreme heat and its health impacts. However, without broader federal actions and standards, protections will vary across states. As climate change accelerates and intensifies extreme heat, the impacts of the rollbacks of environmental protections and equity initiatives will likely widen existing health disparities, reduce community resilience, and weaken the federal government’s ability to respond to extreme climate events.

This brief provides an overview of the federal and state landscape of recent policies addressing extreme heat and health equity.

Prior administrations implemented efforts to address climate change, extreme heat, and their impacts on human health in recent decades. In 1990, President George H.W. Bush implemented the Global Change Research Act of 1990, which created the U.S. Global Change Research Program (USGCRP) and required the release of the National Climate Assessment (NCA) every four years. The USGCRP has advanced climate change research over the past 35 years, and the NCA continues to report scientific research on climate change and its impacts on the U.S., helping to inform community responses to climate-related challenges. The Clinton administration implemented an Executive Order on “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations”, which required federal agencies to make identifying and addressing environmental justice a key part of their missions. Federal agencies were tasked with determining whether their programs had disproportionate detrimental effects on underserved populations through exposure to environmental hazards, including heat. The Executive Order also directed the creation of an Interagency Working Group on Environmental Justice to identify the disproportionate effects of environmental hazards exposure on communities of color and low income groups, and developing an environmental justice strategy. President George W. Bush’s administration was characterized by a withdrawal from leadership in federal regulation of climate change, including the U.S.’ withdrawal from the Kyoto protocol, an international agreement to lower greenhouse emissions that contribute to global warming and climate change. The Obama administration implemented the Memorandum of Understanding on Environmental Justice, highlighting the disproportionate burden of pollution and environmental hazards on communities of color and low income groups. The Obama administration also created the National Integrated Heat and Health Information System (NIHHIS), which sought to increase community preparedness for extreme heat events. NIHHIS integrated heat and health information across the federal government to support on-the-ground efforts to reduce the impacts of extreme heat on human health.

The Biden administration took additional steps to address the impacts of climate change, extreme heat, and exposure to environmental hazards on human health. These actions included the Executive Order, “Revitalizing Our Nation’s Commitment to Environmental Justice for All”, which created the Office of Environmental Justice and External Civil Rights to identify gaps in data and the cumulative impacts of environmental justice on underserved groups. The Biden administration also implemented Executive Order, “Tackling the Climate Crisis at Home and Abroad”, to elevate climate change as a national security priority. Among other actions, it established the Office of Climate Change and Health Equity (OCCHE) within the Department of Health and Human Services, which aimed to address the impact of climate change on health and developed tools to help track heat-related illnesses. Additionally, the U.S. Department of Housing and Urban Development implemented measures, including increasing utility allowances to help mitigate the effects of extreme heat in public housing.

The Biden administration also implemented policies to specifically address the impacts of extreme heat on workers. In 2022, the Occupational Safety and Health Administration (OSHA) launched the National Emphasis Program for Outdoor and Indoor Heat-Related Hazards, an enforcement program that sought to identify and eliminate or reduce worker exposures to occupational heat-related illnesses and injuries. The program was an expansion of the agency’s heat-related illness prevention initiative. In 2021, OSHA began engaging with stakeholders to develop regulations to protect workers from heat-related hazards and established a Heat Injury and Illness Prevention Work Group, which made recommendations for heat injury and illness prevention standards. In 2024, OSHA issued a proposed rule on Heat Injury and Illness Prevention in Outdoor and Indoor Work Settings. The proposed rule would require employers to have written heat injury and illness prevention plans, heat injury precautions, trainings, and evaluations. Specifically, it would require employers to provide workers with cool drinking water, shade, and more rest breaks once the heat index reached 90 degrees. The public comment period on the rule has closed, but OSHA conducted public hearings through July 2, 2025. Beyond the proposed rule, the administration launched its heat.gov website as a source of information on heat and health. Moreover in 2024, the U.S. Department of Health and Human Services released its National Heat Strategy, a plan to coordinate federal action to address extreme heat and its impacts.

On the first day of its second term, the Trump administration began implementing policies and regulations that reverse efforts to mitigate the impacts of extreme heat on health. President Trump signed Executive Order “Initial Recissions of Harmful Executive Orders and Action” and Executive Order “Ending Illegal Discrimination and Restoring Merit-Based Opportunity”, which revoked key climate change and environmental justice policies implemented by prior administrations. As part of efforts to eliminate diversity and disparities-related initiatives, the Trump administration eliminated environmental justice programs. These actions included eliminating the Low Income Home Energy Assistance Program, which helps low income Americans, many of whom are people of color, pay their energy bills and stay cool during the summer, and terminating grants from the U.S. Department of Agriculture’s urban forestry program, which sought to increase tree canopy cover in low income communities around the country, addressing tree inequity and exposure to extreme heat. The Department of Health and Human Services also eliminated OCCHE, which had developed tools to track heat-related illnesses. The Trump administration also cut more than 90% of the National Institute for Occupational Safety and Health, including the entire heat team involved in efforts to address heat-related illnesses and deaths among workers in the farming and construction industries. In April, the Centers for Disease Control and Prevention (CDC) also fired staff from its Division of Environmental Health and Science Practice (DEHSP) who sought to protect communities from exposure to heat waves, wildfires, and other environmental hazards as well as provided grants to local and state officials to create heat wave plans and build community cooling centers. However, as of June 11th, 2025, at least 150 staff from the National Center for Environmental Health and nearly all workers from the DEHSP were reinstated.

The Trump administration has also taken actions that block or weaken state level climate measures, including heat protection rules. On April 8th, President Trump issued Executive Order “Protecting American Energy from State Overreach,” which directs the Attorney General to identify and block state and local laws that address climate change, environmental, social, and governance initiatives, and environmental justice. CDC’s Climate and Health Program’s Climate-Ready States and Cities Initiative, which helped state and local health departments prepare for and respond to climate-related health outcomes was among the programs cut from CDC’s DEHSP. Thirteen jurisdictions (AR, CA, CT, FL, ME, NY, NC, OR, PR, San Francisco, VT, WI, County of Santa Clara) were recipients of grants from the program. North Carolina’s Department of Health and Human Services reports that the state’s Heat Health Alert System and Heat-Related Illness Surveillance System may be at risk due to these cuts. The alert systems help monitor and identify unhealthy heat levels and heat-related illnesses.

In recent years, many states have enacted climate change legislation related to extreme heat and its impact on human health. Some states, including Maryland, Massachusetts, New York, Vermont, and California, have introduced Climate Superfund Bills that seek to hold fossil fuel producers and refiners responsible for their impacts on climate change, strengthen infrastructure, increase community environmental resilience, and mitigate the impacts of climate change. For example, New York’s Climate Superfund Bill, the “Polluter Pays Bill” is expected to collect $75 billion over 25 years to fund infrastructure and other projects, including the building of cooling centers to help residents stay cool during heat waves. Additionally, some states, including New Jersey, New York, North Carolina, and Arizona, have released Extreme Heat Action Plans that seek to build community resilience through coordinated government action, educating the public on extreme heat, and developing heat-ready infrastructure. The plans also direct and coordinate investments in historically disadvantaged communities that are disproportionately vulnerable to extreme heat. In North Carolina, the Heat Action Toolkit includes steps for health care providers and other leaders to care for disproportionately affected communities during heat waves. Some states are also engaging in programs to mitigate the impact of extreme heat on Medicaid enrollees. As of July 2024, 13 states have used Section 1115 Medicaid waivers to facilitate access to air conditioning. Oregon was the first state to implement this program to support vulnerable residents during extreme heat events.

California, Colorado, Maryland, MinnesotaNevada, Washington, and Oregon are addressing the health impacts of extreme heat on workers through comprehensive heat protection standards (Figure 1). These standards aim to protect workers who are at greater risk of heat-related illnesses. For example, California’s Heat Illness Prevention Standard mandates access to shade, cool water, and training for outdoor workers. Washington’s Outdoor Heat Exposure Rules implement specific temperature thresholds that trigger safety measures for workers. Thirteen additional states are in the process of developing their own occupational heat safety standards, including New Mexico, which has a Heat Illness and Injury Prevention Rule under public comment.

In contrast, Texas and Florida implemented legislation that limit their county- and municipal-level governments’ abilities to provide certain heat protections for outdoor workers. In 2023, Texas enacted House Bill 2127, also known as the “Death Star Bill,” which preempts local laws, including heat protection standards for outdoor workers. In 2024, Florida enacted House Bill 433, which prevents city and county governments from requiring that employers, including government contractors, provide heat protections for outdoor workers outside of those required under state or federal law. These protections include requiring water breaks and other cooling measures for outdoor workers.

Seven States Have Implemented Occupational Heat Safety Standards

Health Care Access and Financial Barriers Among LGBT People Amidst Looming Health Care Cuts

Published: Jul 17, 2025

On July 4, 2025, President Trump signed the recent reconciliation bill into law which is expected to leave millions of low- and moderate-income people uninsured as they lose access to Medicaid. Additionally, questions remain about whether Congress will preserve enhanced Affordable Care Act (ACA) premium tax credits for those with marketplace coverage, without which millions more could find premiums unaffordable, disenroll, and become uninsured. Given LGBT adults have lower incomes and higher rates of Medicaid coverage than non-LGBT adults, these changes could disproportionately impact this community. Additionally, as LGBT people experience a wide range of health disparities, cost barriers may serve to exacerbate these differences.

This brief reviews new data from the May 2025 KFF Health Tracking Poll on LGBT adult’s experiences and concerns related to health care affordability. Overall, the survey findings show that LGBT adults face more widespread problems and concerns with health care affordability compared to non-LGBT adults. While this may reflect the lower average incomes of LGBT adults, many of these concerns cut across income, with similar shares of LGBT adults reporting concerns regardless of whether they have lower- or more moderate- income.

Findings

U.S. adults face challenges affording a range of common expenses, including those related to health care. Half (51%) of LGBT adults say that in the past year, they or a family member living with them has had problems paying for food, housing, transportation, or other necessities. This compares to three in ten non-LGBT adults. Over one-third (36%) of LGBT adults say they or a family member living with them has had problems paying for health care, compared to one in five (21%) non-LGBT adults. The differences between these groups may be due in part to LGBT adults generally being younger and having lower household incomes than non-LGBT adults. However, even when looking only at those under 35 years old, LGBT adults are still more likely than non-LGBT adults to say they or a household member had problems paying for necessities (62% vs. 38%) and health care (46% vs. 24%).

More than One-Third of LGBT People Say They or a Household Member Face Problems Paying for Health Care, More Than Half Face Challenges Paying for Other Necessities

LGBT adults with household incomes under $40,000 are more likely than LGBT adults with higher incomes to say they or a household member have experienced problems paying for food, housing and other basic necessities in the past year (63% vs. 36%). Issues with health care affordability cut across income levels among LGBT adults, as 40% of lower-income LGBT adults report problems paying for health care in the past 12 months, statistically similar to the share of higher-income LGBT adults who say the same (32%).

Similar Shares of LGBT Adults Across Income Groups Say They Face Problems Paying for Health Care

Paying for health care can be a burden for individuals and families, including for LGBT adults who tend to have lower incomes. About half (52%) of LGBT adults say it is difficult for them to afford their health care costs, including about one in five (18%) who say it is very difficult. This experience is more common among LGBT adults than non-LGBT adults and is driven by those finding affordability very difficult.

About Half of LGBT Adults Face Difficulties Affording Health Care, with About One in Five Saying it is Very Difficult

These challenges with affordability can have an impact on access to and willingness to seek care. Half (51%) of LGBT adults report that they have skipped or postponed getting the health care they needed in the past year because of the cost compared to one-third (34%) of non-LGBT adults. About half of LGBT adults with incomes under $40,000 (50%) and about half of those with incomes of $40,000 or more (53%) say they have skipped getting needed health care because of the cost. Additionally, one in four (25%) LGBT adults say their health got worse because they skipped or postponed care because of the cost, compared to 18% of non-LGBT adults who say the same.

Half of LGBT Adults Report Skipping or Postponing Care Due to Cost and One in Four Say Their Health Got Worse as a Result

Similarly, costs related to prescription drugs also lead some LGBT adults to take actions to reduce their expenses in this area. About one-third (32%) have taken an over-the-counter drug instead of getting a prescription filled, a quarter (26%) have not filled a prescription because of the cost, and almost as many (23%) have cut pills in half or skipped doses. More than four in ten LGBT adults (44%) report taking at least one of these actions, compared to about a third (32%) of non-LGBT adults. Notably, similar shares of LGBT adults with incomes under $40,000 and those with incomes of $40,000 or more report taking at least one of these cost saving actions with their prescription medications (43% and 46% respectively).

More than Four in Ten LGBT Adults Report Taking Cost-Saving Actions Related to Prescription Medication Cost, Including Not Filling it and Skipping Doses

Not surprisingly, these experiences translate to worry. Over half of LGBT adults express worry about being able to afford each of the following for themselves and their family: health costs, unexpected medical bills, rent/mortgage, food, gas/transportation, and utilities. Worry about affording health costs and unexpected medical bills are among the expenses of greatest concern to LGBT adults, with about two-thirds reporting they are worried about these expenses (68% and 66%, respectively). LGBT adults are more likely than non-LGBT adults to report affordability concerns related to rent/mortgage, food, and gas/transportation and similarly likely to report such concerns related to health care costs.

Worry About Affording Health Services Costs is Widespread Among LGBT People

ACA Preventive Services Are Back at the Supreme Court: Kennedy v. Braidwood

Authors: Laurie Sobel, Alina Salganicoff, and Mabel Felix
Published: Jul 17, 2025

On June 27, 2025, the U.S. Supreme Court issued the opinion for Kennedy v. Braidwood Management, finding that the ACA requirement that most private insurers and Medicaid expansion programs cover preventive services recommended by the United States Preventive Services Preventive Task Force (USPSTF) with no cost-sharing is constitutional. In its decision, the Court affirmed that USPSTF members are appointed constitutionally, and the Secretary of Health and Human Services can remove USPSTF members at-will and directly review and block Task Force recommendations before they take effect.

In this case, the Supreme Court narrowly considered whether the structure of USPSTF violates the Appointments Clause, but did not review the litigants’ other claims about the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA). The federal district court will now resume briefing on the consideration of the plaintiffs’ claim that the Secretary of Health and Human Services’ ratification of HRSA and ACIP recommendations violates the Administrative Procedure Act. For more analysis of the Court’s decision please see Kennedy v. Braidwood: The Supreme Court Upheld ACA Preventive Services but That’s Not the End of the Story.

On April 21, 2025, the Supreme Court is hearing oral arguments in Kennedy v. Braidwood Management. In this case, Braidwood Management, Christian owned businesses and six individuals in Texas, have challenged the Affordable Care Act’s (ACA) requirement to cover preventive services. The Supreme Court is narrowly considering whether the structure of the US Preventive Services Task Force (USPSTF) — an independent entity convened by the federal government that makes recommendations for preventive services that nearly all private insurances must cover without cost-sharing — violates the U.S. Constitution’s Appointments Clause. That provision states that “officers of the United States” may only be appointed by the president, subject to the advice and consent of the Senate and the litigants are claiming that the USPSTF does not have the authority to set coverage requirements. The Supreme Court is not considering the litigants’ other claims including those that the recommendations violate the Religious Freedom Restoration Act (RFRA), or their Appointment’s Clause claims about the Advisory Committee on Immunization Practices (ACIP), or the Health Resources and Services Administration (HRSA).

Even though President Trump had supported ACA repeal in his first term, his administration is  defending the lawsuit. On its face this may seem unexpected, but the outcome of the case could give the administration broader latitude to shape the recommendations issued by the entities that were originally established with the goal of providing independent analysis and review. This brief provides an overview of the most recent ACA case under review at the Supreme Court and discusses the implications of the potential rulings by the high court.

The ACA and Preventive Services

Section 2713 of the ACA requires most private health insurance plans and Medicaid expansion programs to cover a range of recommended preventive services without any patient cost-sharing. Preventive services include a range of services such as screening tests, immunizations, behavioral counseling, and medications that can prevent the development or worsening of diseases and health conditions. Preventive services that must be covered are those receiving an A or B grade by the U.S. Preventive Services Task Force (USPSTF), vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) recommendations issued by the Women’s Preventive Services Initiative and the Bright Futures for Children program. All of these entities review new recommendations and conduct periodic updates of existing recommendations.

What Is the Case?

In the original case, filed in 2022, the respondents claimed that the preventive services requirements for private health insurance are unconstitutional and also that the requirement to cover pre-exposure prophylaxis treatment (PrEP) (medication to prevent getting HIV from sex or injection drug use for those at risk) violates the Religious Freedom Restoration Act (RFRA). The respondents are six individuals and Christian-owned businesses. Braidwood Management, a for-profit closely held organization, owned by a trust, with Dr. Steven F. Hotze, as the sole trustee and beneficiary. Braidwood is self-insured and provides health insurance to its 70 employees. The other respondent is Kelley Orthodontics, who identify themselves as a “Christian professional association” owned by respondent, John Kelley. The respondents assert both economic harm for having to pay more money for a health plan that includes services they do not want or need, and religious harm for having to include services they object to.

In 2022, the District Court, agreeing with Braidwood’s arguments, ruled that the appointment of members to USPSTF violated the Appointments Clause and that the requirement to cover PrEP violates RFRA. However, the Court also found that the ACA’s delegation to ACIP and HRSA is not in violation of the Appointments Clause since the Secretary of HHS effectively has the authority to ratify or not the ACIP and HRSA recommendations. In 2023, the District Court issued a ruling striking down the ACA’s requirement for no cost coverage of preventive services recommended or updated by USPSTF on or after March 23, 2010. This ruling, however, was subsequently paused as the case made its way through the appeals process

In June 2024, the 5th Circuit Court of Appeals affirmed the district court’s ruling that the ACA’s requirement to cover without cost-sharing services recommended by United States Preventive Services Task Force (USPSTF) is unconstitutional. However, they ruled that a nationwide remedy was not proper and that only the plaintiffs are permitted to exclude USPSTF recommended services from their plans. The Appeals Court sent back to the district court the plaintiffs’ claim that the Secretary of Health and Human Services’ ratification of HRSA and ACIP recommendations violates the Administrative Procedure Act for further briefing and a judgment. The Supreme Court is considering only the arguments regarding whether the structure of USPSTF violates the Appointment’s Clause, not the other bodies that make preventive services recommendations, nor the religious harm included in the original case. However, a separate set of claims regarding HRSA and ACIP are still being considered by the district court and could be before the Supreme Court at a future date.

What Is the Supreme Court Considering?

The current case before the Supreme Court is reviewing the 5th Circuit Court of Appeals decision holding that appointments of individuals to the USPSTF and the recommendations made by the USPSTF after the enactment of the Affordable Care Act in 2010 (see Table 1) violate the Appointments Clause of the U.S. Constitution since they were not appointed by the President and confirmed by the Senate.

Braidwood et al. contend that the requirement for health plans to cover preventive services recommended or amended by USPSTF since the enactment of the ACA in March 2010 violates the Appointments Clause of the Constitution. They argue this is unconstitutional since the ACA does not allow the Secretary of HHS to reject the recommendations made by the Task Force or require it to make specific recommendations, meaning that USPSTF members have the capacity to unilaterally determine the preventive care that private insurers must cover and act as officers of the United States. Additionally, they contend the Secretary lacks the authority to remove USPSTF members at will. They argue that for USPSTF’s structure and recommendations to be constitutional, members would have to be appointed by the president and Senate.

The federal government argues that the HHS Secretary has constitutionally appropriate oversight over USPSTF because they may remove members at will and determine when health insurance issuers must start providing coverage for new recommendations. HHS additionally argues that if the Court holds that capacity to remove members at will is not sufficient oversight, it can remedy this by construing federal law to allow the Secretary to review USPSTF recommendations directly, which would address any remaining questions of oversight. This degree of supervision by the Secretary of HHS, the agency argues, would mean that members of the Task Force are “inferior officers,” who may be appointed or removed by the Secretary and would not require appointment by the president and Senate.

Major Additions and Revisions to USPSTF Recommendations Made Since March 23, 2010

Potential Impact on Coverage

If the Court rules in favor of Braidwood, private health insurers would no longer be required to cover, without cost sharing, preventive services recommended by USPSTF after 2010 when the ACA was enacted. Any new service that was recommended or updated by USPSTF after March 2010 (and is not also recommended by HRSA or ACIP) would no longer be required to be covered without out-of-pocket costs. For example, services and medications like statins to prevent heart disease, lung cancer screening, and PrEP to prevent HIV could be subject to copays, deductibles, or coinsurance, potentially deterring access to these services. This essentially means that the standards and recommendations that the federal government would be able to enforce would not reflect current or future standards and evidence, locking required preventive services in place as of the state of the science in 2010.

Although many of the friend of the court briefs presented to the Supreme Court for this case focus on the impact of coverage of USPSTF recommendations with no cost-sharing, a ruling in favor of the federal government does not guarantee that coverage will be required for these preventive services. As the federal government argues, HHS Secretary Robert F. Kennedy Jr. has the power to remove USPSTF members at will and to review the recommendations they issue. This means that the Trump administration could change the membership of the USPSTF in ways that may significantly alter the recommendations it issues. Additionally, in their briefs, the Trump Administration’s HHS contends the Secretary can direct that the implementation of recommendations issued by USPSTF can be delayed indefinitely and that the Secretary may have additional authority to supervise and veto Task Force recommendations. In their brief they state, “In addition to removing Task Force members at will, the Secretary may supervise and review their recommendations directly.”

The Supreme Court is expected to issue its ruling in June. Regardless of how the Court rules in this specific case, it will likely not be the final word on the ACA required coverage of preventive services recommended by USPSTF, ACIP and HRSA.

Explaining Litigation Challenging the ACA’s Preventive Services Requirements: Braidwood Management Inc. v. Becerra

Published: Jul 17, 2025

On June 27,2025, the U.S. Supreme Court issued the opinion for Kennedy v. Braidwood Management, finding that the ACA requirement that most private insurers and Medicaid expansion programs cover preventive services recommended by the United States Preventive Services Preventive Task Force (USPSTF) with no cost-sharing is constitutional. In its decision, the Court affirmed that USPSTF members are appointed constitutionally, and the Secretary of Health and Human Services can remove USPSTF members at-will and directly review and block Task Force recommendations before they take effect.

In this case, the Supreme Court narrowly considered whether the structure of USPSTF violates the Appointments Clause, but did not review the litigants’ other claims about the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA). The federal district court will now resume briefing on the consideration of the plaintiffs’ claim that the Secretary of Health and Human Services’ ratification of HRSA and ACIP recommendations violates the Administrative Procedure Act. For more analysis of the Court’s decision please see Kennedy v. Braidwood: The Supreme Court Upheld ACA Preventive Services but That’s Not the End of the Story.

Since the enactment of the Affordable Care Act (ACA) in 2010, more than 2,000 legal challenges have been filed in state and federal courts contesting part or all of the ACA. The most recent challenge involves the ACA requirement that most private insurance plans cover recommended preventive care services without cost sharing. In this case, Braidwood Management v. Becerra, Christian owned businesses and six individuals in Texas assert that (1) the requirements in the law for specific expert committees and a federal government agency to recommend covered preventive services is unconstitutional, and that (2) the requirement to cover preexposure prophylaxis (PrEP), medication for HIV prevention, violates their religious rights. If the plaintiffs prevail on either the constitutional or the religious claims, the government’s ability to require insurance plans to cover evidence-based preventive services without cost-sharing may be limited.

On September 7, 2022, Judge Reed O’Connor at the US District Court in the Northern District of Texas ruled partly in favor of the plaintiffs and partly in favor of the Department of Health and Human Services (HHS), which is defending the ACA. On March 30, 2023, Judge O’Connor issued a ruling for the remedy in this case, Braidwood Management v. Becerra, striking down part of the ACA’s requirement for no cost coverage of preventive services recommended or updated by the U.S. Preventive Services Task Force (USPSTF) on or after March 23, 2010 and finding that the requirement to cover PrEP medications for HIV prevention violates the rights of the plaintiffs who have religious objections to PrEP. The federal government appealed this decision and on May 15, 2023 the 5th Circuit Court of Appeals issued an administrative stay of the district court’s ruling. This means that the federal government can continue enforcing the preventive services requirement while the 5th Circuit considers the Department of Justice’s motion for a stay pending appeal. This brief explains the preventive services coverage requirements, the basis of the lawsuit, next steps in the litigation, and the potential implications.

Preventive Services Provision

The ACA requires most private health insurance plans to cover a range of recommended preventive services without any patient cost-sharing. Preventive services include a range of services including screening tests, immunizations, behavioral counseling, and medications that can prevent the development or worsening of diseases and health conditions. The preventive services that private plans and Medicaid expansion programs must cover are based on those receiving an A or B level recommendation by the U.S. Preventive Services Task Force (USPSTF), vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Women’s Preventive Services Initiative and issued by the Bright Futures for Children program. As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date.

Judge Reed O’Connor has heard multiple challenges to the ACA

U.S District Judge Reed O’Connor, an appointee of President George W. Bush, has been the “go-to” judge for plaintiffs challenging the ACA. In 2018, he ruled that the entire ACA was unconstitutional because Congress zeroed out the tax penalty. The Supreme Court ultimately ruled the other way and upheld the ACA. In June 2019, Judge O’Connor issued a permanent injunction against the ACA’s contraceptive coverage requirement, blocking the federal government from enforcing it against employers and individuals who object to contraceptive coverage. Judge O’Connor has also ruled in favor of the plaintiffs in challenges to the ACA Section 1557.

Preventive Services Litigation

In the current case, Braidwood Management Inc. v. Becerra, the plaintiffs claim that the preventive services requirements for private health insurance are unconstitutional and the requirement to cover PrEP-specific coverage requirement violates the Religious Freedom Restoration Act (RFRA) (Table 2). The plaintiffs are six individuals and Christian owned businesses. Braidwood Management, a for-profit closely held organization, owned by a trust, with Dr. Steven F. Hotze, a religious Christian, as the sole trustee and beneficiary. Braidwood is self-insured and provides health insurance to its 70 employees. The other plaintiff is Kelley Orthodontics, a Christian professional association owned by plaintiff John Kelley. The plaintiffs are asserting both economic harm for having to pay more money for a health plan that includes services they do not want or need, and religious harm for having to include services they object to.

Plaintiff Claims

Position 1: The Preventive Services Provision violates the Appointments Clause

The plaintiffs contend that the ACA provisions violate the Appointments Clause of the US Constitution, which provides that “officers of the United States” may only be appointed by the president, subject to the advice and consent of the Senate. They claim that the members of USPSTF, ACIP and HRSA are “officers of the United States” who have not been appointed in conformity with the Appointments Clause because they were not nominated by the President and approved by the Senate. Rather, members of these bodies are appointed by the heads of agencies within HHS (Table 1). The plaintiffs are asking the court to declare all preventive-care mandates based on recommendations or guidelines issued by USPSTF, ACIP or HRSA after March 23, 2010 (the day the ACA was signed into law) as unconstitutional. The plaintiffs contend that the ACA does not allow the Secretary of HHS or the directors of the agencies within HHS to reject the recommendations made by the committees and is thus insufficient oversight.

Conversely, HHS contends that “there are numerous statutes that incorporate by reference independent recommendation without creating any requirements that the heads of the recommending bodies be appointed as officers of the United States.” They cite examples such as a public health regulation related to water standards for consumer products that outsources the development of those standards to a non-governmental organization. Similarly, they cite a law requiring states and designated database providers to use a format for an electronic database approved by an expert panel that is not subject to approval by the head of a federal agency.

Table 1: Committees Issuing Recommendations for Preventive Services
Recommending EntityRole of the AgencyProcess for Appointments and Oversight
United States Preventive Services Task Force (USPSTF)The U.S. Preventive Services Task Force is an independent, volunteer panel of national experts in disease prevention and evidence-based medicine. The Task Force works to improve the health of people nationwide by making evidence-based recommendations about clinical preventive services.USPSTF members appointed by the Director of AHRQ to serve 4-year terms.

USPSTF recommendations are not subject to AHRQ oversight or approval.
Advisory Committee on Immunization Practices (ACIP)The ACIP shall provide advice and guidance to the Director of the CDC regarding use of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population of the United States.The Secretary of the U.S. Department of Health and Human Services selects the members following an application and nomination process.

Recommendations made by the ACIP are reviewed by the CDC Director, and if adopted, are published as official CDC/HHS recommendations which determines insurance coverage policy.
Health Resources and Services Administration (HRSA) – Women’s Preventive Services InitiativeHRSA is an agency of the U.S. Department of Health and Human Services that operates programs intended to provide equitable health care to people who are geographically isolated and economically or medically vulnerable.HRSA contracts with an external organization, currently ACOG, to convene a panel of experts, the Women’s Preventive Services Initiative (WPSI) to make and update recommendations for women’s preventive services.

HRSA can accept or reject recommendations which determines insurance coverage requirements.
HRSA — Bright Futures for ChildrenHRSA (see above)HRSA uses the guidelines developed by The Bright Futures Program to identify evidence-informed guidelines for preventive care screenings and routine visits for newborns through adolescents up to age 21. The American Academy of Pediatrics (AAP) convenes experts in pediatric care with support from HRSA to review scientific evidence and recommend updates.

Plaintiff Position 2: The Preventive Services Provision violates the Nondelegation Doctrine

The plaintiffs contend the ACA’s preventive services provisions violate the nondelegation doctrine – based on the theory that since Article I of the Constitution vests legislative power in Congress, there are limits to the authority that Congress can delegate to federal administrative agencies. The current caselaw precedent requires statutes that delegate authority to agencies to supply an “intelligible principle” to guide and provide a boundary or limit on the agency’s discretion. The plaintiffs contend that an “intelligible principle” is lacking: “Yet there is nothing in the text of section 300gg-13(a) that purports to guide the discretion of [US]PSTF, ACIP or HRSA when choosing the preventive care that private insurance must cover.” The plaintiffs contend that this constitutional nondelegation problem can be averted if the phrase “current recommendations is construed to refer to the recommendations that existed when the ACA was signed into law.”

The plaintiffs point to comments in the Supreme Court’s opinion in Little Sisters of the Poor, as evidence that the current majority believes there could be a constitutional issue with delegation to HRSA for preventive services for women, including contraception: “On its face, then, the provision grants sweeping authority to HRSA to craft a set of standards defining the preventive care that applicable health plans must cover. But the statute is completely silent as to what those “comprehensive guidelines” must contain, or how HRSA must go about creating them. The statute does not, as Congress has done in other statutes, provide an exhaustive or illustrative list of the preventive care and screenings that must be included.” While the Little Sisters case, challenging the contraceptive coverage regulations, was not decided based on the nondelegation doctrine, there is growing speculation that the Supreme Court is poised to revisit the nondelegation doctrine to make it more difficult for Congress to delegate authority to federal agencies to address major policy details.

Plaintiff Position 3: The Preventive Services Provision violates the Religious Freedom Restoration Act

The plaintiffs assert the requirements to cover PrEP violates the Religious Freedom Restoration Act. Relying on the Supreme Court’s ruling in Burwell v. Hobby Lobby, the plaintiffs contend that employers are left with a “Hobson Choice” to provide health insurance that covers these medications and services that violate their religious beliefs or refuse to offer any health insurance to its employees. Notably, the plaintiffs state the requirement to cover PrEP “imposes a substantial burden on the religious freedom of those who oppose homosexual behavior on religious grounds” claiming further that PrEP drugs “facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use.” The plaintiffs also contend the provision violates individuals who have religious objections and wish to purchase health insurance without PrEP coverage.

District Court’s Decision

Finding that Braidwood has standing to pursue its claims, on September 7, 2022, Judge O’Connor ruled that that the ACA’s delegation to U.S. Preventive Services Task Force violates the Appointments Clause because the Secretary cannot direct USPSTF to give a specific preventive service an “A” or “B” rating . The Court finds that the Secretary does not have any authority to direct which services are covered under § 300gg-13(a)(1) and concludes that USPSTF members are officers of the United States and that their selection does not comply with the Appointments Clause procedures. However, the Court also found that the ACA’s delegation to ACIP and HRSA are not in violation of the Appointments Clause since the Secretary of HHS effectively has the authority to ratify or not the ACIP and HRSA recommendations.

The court rejected the plaintiff’s nondelegation doctrine claims stating that the preventive care law met the criteria set out in prior Fifth Circuit cases on when Congress has properly provided an “intelligible principle” to guide agency discretion. Judge O’Connor noted that the Supreme Court might soon “reexamine or revive” the nondelegation doctrine, but it’s too early to predict a change in the nondelegation criteria from comments made in the Little Sisters case.

Relying on the reasoning in the Supreme Court’s decision in Hobby Lobby, the District Court also found that the requirement to cover PrEP violates Braidwood’s religious rights under the Religious Freedom Restoration Act (RFRA).

On March 30, 2023, District Court Judge O’Connor issued a ruling for the remedy in the case, Braidwood Management v. Becerra, striking down part of the ACA’s coverage requirement for preventive services. Effective immediately nationwide, the ruling blocks the federal government from requiring health plans to cover services recommended or updated by the U.S. Preventive Services Task Force (USPSTF) on or after March 23, 2010. The ruling did not affect coverage requirements for USPSTF services recommended prior to that date and also did not affect the requirement for plans to cover Women’s Preventive Services recommended by Health Resources and Services Administration (HRSA) or vaccines recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP). Additionally, the judge ruled that the requirement to cover PrEP medications for HIV prevention violates the rights of the plaintiffs who have religious objections to PrEP. The federal government has appealed this decision to the United States Court of Appeals for the 5th Circuit. On May 15, 2023 the 5th Circuit Court of Appeals issued an administrative stay of the district court’s ruling. This means that federal government can continue enforcing the preventive services requirement while the 5th Circuit considers the Department of Justice’s motion for a stay pending appeal.

Implications for Coverage and Access to Preventive Services in Private Health Insurance

Even if the Court’s ruling upholds the authority of HRSA and ACIP, USPSTF recommendations include a broad range of services across multiple populations and health conditions. This includes cancer screenings, preventive medications for chronic conditions such as cardiovascular disease, counseling on health behaviors related to nutrition and weight management, alcohol and drug use, tobacco cessation services, screening for depression, and prenatal services, Elimination of the coverage requirements for USPSTF recommendations would invalidate the requirement to cover all of these services without cost sharing.

Religious Objections to PrEP Coverage

The ACA’s contraceptive coverage provision has been one of the most litigated parts of the law, with three cases brought by employers who object to the coverage on religious grounds reaching the Supreme Court. The Court’s ruling on the PrEP coverage requirement is the first time a court has ruled in favor of plaintiffs challenging another preventive service based on religious objections.

If employers who object to including coverage for PrEP in their plans are allowed to exclude the coverage, employees could lose coverage for a medication that could prevent the transmission of HIV and HIV related morbidity and mortality. PrEP reduces the risk of acquiring HIV by approximately 99% through sex and 74% through injection drug. Given that over 80% of PrEP users are covered by commercial insurers, this could have significant ramifications for cost and access should the ruling be applied broadly. The cash price for generic PrEP (Emtricitabine / Tenofovir), which is about 99% effective at preventing HIV through sex, is approximately $30 per month. This compares to an estimated lifetime HIV treatment cost of $420,285 ($1,079,999 undiscounted).

In addition, allowing employers to exclude PrEP because of religious objections has the potential to open the door to employers objecting to other services, such as vaccines.

Implications for Access to Preventive Services in Medicaid & Medicare

While the plaintiffs in Braidwood are only challenging the preventive services required in private health insurance plans, Medicaid and Medicare also have requirements for coverage of preventive services. States that have expanded Medicaid eligibility under the ACA must cover Essential Health Benefits (EHBs) as defined by the ACA. One of the categories of EHBs is preventive services, which CMS has defined to include the same services as required for private insurance plans. As a result, all states must cover the preventive services recommended by USPSTF, ACIP and HRSA for enrollees who qualify through the Medicaid expansion pathway. If this litigation is successful in challenging any of the preventive services required in private health insurance plans, the requirement for preventive services for enrollees who qualify through the Medicaid expansion pathway would be left to individual states to determine based on their state private insurance benchmark plan, which may not include all the services currently required.

While Medicaid relies on the same agencies to determine the recommended services as private insurance plans must cover, the process is slightly different under Medicare. In that case, under the national coverage determination process, the Secretary of HHS has the authority to determine coverage for preventive services for Medicare beneficiaries. The ACA eliminated Medicare cost sharing, including coinsurance and deductibles, for most preventive benefits that are rated A or B by the USPSTF, beginning in 2011, and authorized the Secretary of HHS to add coverage for new preventive services, using the national coverage determination process, if they are: reasonable and necessary for prevention or detection of illness; rated A or B by the USPSTF; and appropriate for Medicare beneficiaries. Coverage under Medicare for several preventive services, including some rated A or B by the USPSTF, predated the ACA and is specified in statute, and therefore would not be affected by any ruling on the current litigation.

The current litigation is brought by employers and individuals who allege economic and religious harm from the preventive services requirements in private health insurance. Any litigation challenging the preventive services requirements under Medicaid or Medicare would need to be brought by plaintiffs who suffer a tangible harm to establish legal standing.

Broader Implications

Overturning the preventive services requirement broadly would have significant implications for coverage of a broad range of clinical preventive services. Should the final decision for this case be found in favor of the plaintiffs, and applied nationwide, then millions of people may be vulnerable to loss of guaranteed coverage of preventive services without cost sharing. It will again be at the discretion of plans and employers to determine what preventive services will be covered and whether they will charge cost-sharing, lowering premiums in some cases, but likely creating a patchwork of coverage for these services. This could widen access barriers for groups that already face increased barriers dure to cost, including low-income people and people of color.

Should this case reach the US Supreme Court, the broader implications of a final decision in favor of the plaintiffs will depend on the basis for the ruling. The Court could rule in favor of the plaintiffs based on the Appointments Clause argument, similar to Judge O’Connor’s decision, finding that USPSTF members are officers of the United States who have not been properly appointed.

The potential implications are much broader, however, if the Supreme Court revisits and revises the nondelegation doctrine and restricts Congress’ ability to delegate the development of very precise standards to federal agencies. Without allowing the agencies to update the recommended preventive services, Congress would have to pass a new law every time the USPSTF recommends a new preventive service in order for it to be covered without cost-sharing. Any decision that changes the standard for Congress’ delegation could limit agency discretion to address a broad range of health and other issues through regulation.

Beyond preventive care, much of health policy and law has been developed through the delegation of authority to federal agencies to develop standards to address complex public policy and technical requirements—from the prescription drug approval process of the FDA to the apparatus set up to review and annually update the Medicare fee schedule. The ACA itself specifically left it up to the Secretary of HHS to define the essential health benefits that insurers must cover in the individual and small group insurance markets within the framework of the ten categories of items and services that Congress set out. The authority Congress gave to HHS to temporarily waive certain healthcare requirements during the COVID public health emergency is probably the best example of how delegated authority has functioned to benefit public health as well as access to public and private health insurance coverage. Any movement by the Court to restrict Congress’ authority to delegate in these areas could have a profound effect on the daily lives of Americans.

We do not know how quickly the United States Court of Appeals for the 5th Circuit will rule on this case. Ultimately, the parties are likely to appeal to the Supreme Court.

Table 2: Braidwood v. Becerra: Litigation Challenging the ACA’s Preventive Services Provision: Summary of the Plaintiffs’ and Government’s Position
Claim: The ACA preventive services provisions (42 U.S.C. § 300gg-13(a)(1)–(4)) Violate The Appointments Clause because the members of the committees act as “officers of the United States” and have not be properly appointed

The Appointments Clause provides: [The President] shall have Power, by and with the Advice and Consent of the Senate, to . . . appoint Ambassadors, other public Ministers and Consuls, Judges of the supreme Court, and all other Officers of the United States, whose Appointments are not herein otherwise provided for, and which shall be established by Law: but the Congress may by Law vest the Appointment of such inferior Officers, as they think proper, in the President alone, in the Courts of Law, or in the Heads of Departments.

U.S. Const. art. II § 2. Y
Plaintiffs’ Position:
42 U.S.C. § 300gg-13(a)(1) – (4) allow the members of the U.S. Preventive Services Task Force, the Advisory Committee on Immunization Practices, and the Health Resources and Services Administration to unilaterally determine the preventive care that private insurers must cover.

These individuals are “officers of the United States,” because they “occupy a continuing position established by law” and exercise “significant authority pursuant to the laws of the United States.” Yet none of these officers have been appointed in conformity with the Appointments Clause.
Government’s Position:
The secretary’s ratification of the current preventive services coverage requirements defeats plaintiffs’ appointments clause claim

HRSA and the CDC (which ACIP Advises) are components of the HHS that exercise the secretary’s power and are under the secretary’s control.

The USPSTF is an independent body that does not exercise Executive Power. Its independent recommendations about the quality of evidence backing the effectiveness of certain preventive services is separate from any judgment about what should or should not be covered by health insurance, which latter judgment was made by Congress.
Claim: The ACA preventive services provisions (42 U.S.C. § 300gg-13(a)(1)–(4)) violate the nondelegation doctrine because Congress did not provide any details to guide the recommendations for preventive services
Plaintiffs’ Position:
There is nothing in the text of section 300gg-13(a) that purports to guide the discretion of USPSTF, ACIP or HRSA when choosing the preventive care that private insurance must cover.
Government’s Position:
“Delegations are constitutional so long as Congress ‘lay[s] down by legislative act an intelligible principle to which the person or body authorized [to exercise the authority] is directed to conform.”

The grants of authority under 42 U.S.C. § 300gg-13(a) fall well within the wide range of delegations approved by the Supreme Court and the Fifth Circuit and are consistent with established limits on Congress’s power to delegate.

Congress did not “delegate” power to PSTF at all but instead incorporates its work.
Claim: Certain provisions of the ACA’s preventive services coverage requirements violate the Religious Freedom Restoration Act: requires the government to show the law in question, in this case the requirement that plans include coverage of PrEP without cost sharing, furthers a “compelling interest” in the “least restrictive means” when it “substantially burdens a person’s exercise of religion.”
Plaintiffs’ Position:
The compulsory coverage of PrEP drugs, the HPV vaccine and the screenings and behavioral counseling for STDS and drug use violate the Religious Freedom Restoration Act (RFRA).

Plaintiffs are opposed for religious reasons to sexual activity outside of marriage between one man and one woman.

Requiring for providing Coverage of PrEP drugs facilitates and encourages homosexual behavior, intravenous drug use and sexual activity outside of marriage between one man and one woman.
Government’s Position:
The plaintiffs have failed to demonstrate the PrEP coverage requirement substantially burdens their religious beliefs.

The plaintiffs cannot identify any impact on their health insurance premiums arising from the requirement to cover PrEP drugs.

Even if the plaintiffs could show a substantial burden, the government has a compelling interest in countering the spread of HIV infections, and the plaintiffs have not argued that there is a less restrictive way of meeting this compelling interest (requiring private health insurance to cover PrEP without cost sharing).

How Does the Federal Government Monitor Vaccine Safety?

Published: Jul 16, 2025

Introduction

Vaccines are essential tools for public health that help prevent millions of hospitalizations and deaths each year in the U.S. alone. Vaccines are also overwhelmingly safe, with serious negative side effects from vaccinations being very rare. Even so, side effects and adverse events do happen, which makes it important to continually monitor vaccine safety and to investigate and respond to serious events that are detected, and to assess whether they are linked to vaccination. For this reason, the federal government has multiple systems in place that track vaccine safety. At the same time, the issue of vaccine safety in the U.S. has been increasingly contested, and is currently facing growing scrutiny, including from Trump administration officials. For example, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. has raised questions about vaccine safety, saying he believes the federal government is not doing enough to monitor adverse events and has not been transparent about the data on vaccine safety that it does have. Prior to becoming HHS Secretary, Kennedy said that the federal government had failed to conduct comprehensive studies on vaccine safety and said he believes the federal vaccine safety system captures only a tiny fraction of adverse events from vaccinations. As Secretary, Kennedy has also said he wishes to overhaul the federal government’s approach to vaccine safety monitoring, including by creating a division at the Centers for Disease Control and Prevention (CDC) to focus on vaccine-related injuries and implementing an automated system to track such injuries. In addition, members of the Advisory Committee on Immunization Practices (ACIP), a key vaccine advisory committee for the federal government that was newly constituted by Kennedy in June 2025, have echoed some of these same concerns about vaccine safety and have pledged to revisit vaccine safety issues through ACIP. Further, the safety of COVID-19 vaccines and the ability of the federal government to detect adverse events from vaccination has been questioned by the newly appointed chief medical and scientific officer at the Food and Drug Administration (FDA).

Experts within and outside the government have disputed claims about the lack of sufficient federal vaccine safety monitoring, saying the federal government does in fact have systems in place that can track the safety of vaccines, and that these systems are collectively able to identify important safety signals or significant adverse events from vaccinations. These systems include reviews of data collected during the regulatory review process both before and after vaccines are approved for use, analysis of self-reported vaccine injuries from the public, and ongoing surveillance and analysis of data from patient records at a national level. In most cases, these systems have been in place for decades and have been able to identify past vaccine safety issues.

To provide background and help inform current discussions, this brief provides an overview of the main federal systems and databases that monitor vaccine safety.

Background

Safety monitoring of vaccine products has been subject to federal regulatory oversight for over a century. Federal regulation of vaccine safety began formally with the passage of the “Biologics Control Act of 1902”, which authorized federal review of pharmaceutical products in development and which was created in response to a number of deaths caused by the unregulated use of a diphtheria anti-toxin vaccine in 1901. Subsequent laws expanded and clarified the federal role in protecting the public’s health and regulating the safety of drugs and vaccines, spurred on in some cases by safety events. For example, the Federal Food, Drug, and Cosmetic Act passed in 1938 following a number of deaths caused by sulfanilamide (a drug developed to treat streptococcal infections) expanded federal regulatory oversight of the manufacturing, testing, promotion, and distribution of pharmaceuticals. In 1944, the Public Health Service Act (PHSA) was enacted to consolidate and affirm the roles of federal agencies in protecting the public’s health, including review and regulation of pharmaceutical products, and has served as a foundation for continued federal public health efforts.

For many decades, vaccines were regulated primarily by the National Institutes of Health (NIH), but in 1972 Congress moved much of the responsibility for regulatory review of vaccine research and development to the U.S. Food and Drug Administration (FDA). CDC established an early vaccine adverse event tracking system in 1978, called the Monitoring System for Adverse Events Following Immunizations (MSAEFI), which collected reports of adverse events from parents receiving publicly funded vaccines. A major expansion of the vaccine safety monitoring infrastructure took place with the passage of the National Childhood Vaccine Injury Act in 1986, which was passed in response to a growing number of lawsuits filed against vaccine manufacturers claiming serious adverse events linked to administration of the diphtheria-tetanus-pertussis (DPT) vaccine (links not established by epidemiological studies). The law created a requirement for vaccine safety reporting to HHS and led to many of the systems for post-licensure vaccine safety monitoring still in place today and described further below. For example, in 1990, the more robust VAERS system replaced CDC’s MSAEFI system, and the same year the Vaccine Safety Datalink program at CDC was established. In subsequent years, the federal government has expanded these programs and added more, including the 2007 FDA Amendments Act (FDAAA) which required FDA to establish more robust pharmaceutical safety tracking systems. In response, the FDA established several programs drawing information from large administrative insurance databases to identify and analyze safety issues, including the PRISM and BEST initiatives described below, with the latter initially scaled up to track the safety of 2009 H1N1 pandemic influenza vaccines. During the COVID-19 pandemic, the federal government added additional vaccine safety tracking tools, including V-Safe.

Current Federal Vaccine Safety Monitoring Systems

Safety Data from Clinical Trials – FDA

Before being approved and licensed for use in the U.S., all new vaccines must be tested in clinical trials by vaccine developers, and the data from these trials must be submitted to the FDA for regulatory review. (Updates to already licensed vaccines do not necessarily go through the same set of clinical trials, though updated vaccine formulations are still subject to regulatory review and must be approved by FDA). In its clinical trial review, which covers multiple stages of the research and development process, the FDA’s primary considerations are determining that candidate vaccines are safe and effective. As such, reports of adverse reactions or other safety issues are closely monitored and any adverse safety signals are investigated. During later-stage, larger clinical trials, monitoring and evaluation of safety is a key component of data collection and review. Review of vaccine clinical trial data includes internal, confidential review by experts on staff at FDA, as well as external, public review provided typically through the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Based on the conclusions and recommendations from these internal and external experts, the FDA Commissioner decides whether to approve candidate vaccines.

The 2007 FDAA required information from all clinical trials supported with public funds to be recorded in a public database (ClinicalTrials.gov) and set up requirements that trial results also be included in the public database, although raw data from trials is not typically made public as it is considered proprietary under FDA regulations. In addition, data hosted on the ClinicalTrials.gov database relies on investigators and sponsors choosing to submit such information and some, but not all submissions, include study results.

While the clinical trial system has a long history of ensuring that pharmaceutical products licensed for use in the U.S. are safe and effective, and major safety issues are able to be identified before a vaccine is licensed for use, clinical trials are performed in relatively small numbers of people compared to a whole population that might receive a vaccine. Therefore, very rare safety events might be harder to identify during the trials process. This is one reason post-licensure surveillance has been expanded, as required by the FDAA (see below).

Post-licensure Rapid Immunization Safety Monitoring (PRISM) / Biologics Effectiveness and Safety (BEST) – FDA

FDA also monitors safety of medical devices, drugs, and vaccines after they become available on the market. For many of the products it regulates, including vaccines, FDA has often required manufacturers to perform post-licensure safety reviews and submit that information to FDA for review. The 2007 FDAAA law required FDA to expand its post-licensure surveillance capabilities and develop a robust system that used health care data from clinical sites to track safety. In response, FDA created the Sentinel Initiative in 2008, which over time, has grown into a electronic surveillance system that is capable of tracking safety data for over 100 million individual members served by a broad set of health care organizations and clinical sites nationwide. In 2009, HHS initiated the Post-licensure Rapid Immunization Safety Monitoring (PRISM) to help monitor the safety of the H1N1 pandemic influenza vaccine; in 2010, PRISM became an immunization safety component within the Sentinel system and has expanded to include other vaccines. The FDA’s Center for Biologics Evaluation and Research (CBER) oversees another post-licensure vaccine safety program called Biologics Effectiveness and Safety (BEST), which was also created in response to the 2007 FDAAA requirements and launched in 2017. As part of its vaccine safety monitoring efforts, FDA also partners with the Centers for Medicare and Medicaid Services (CMS) to analyze Medicare claims data in order to track safety events among persons aged 65 or older. Using CMS data, FDA is able to perform regular, ongoing analyses looking for pre-specified adverse events following vaccination, as well as perform more specific analyses as needed.

PRISM, BEST, and FDA-CMS have access to large datasets, with hundreds of millions of patients covered by participating systems. These larger study populations allow for more specificity when trying to identify vaccine safety issues but can present challenges when studying longer-term safety issues because individuals may move in and out of different insurance plans over time. It may also take time for data in some of these systems to be made available for analysis (FDA reports a three month average data lag time for the BEST system, for example). To protect confidentiality, FDA does not have direct access to identifying information on patients, with private clinical sites and health insurers that partner with PRISM and BEST retaining their data locally behind firewalls.

Vaccine Adverse Events Reporting System (VAERS) – FDA and CDC

VAERS is a national vaccine safety surveillance program which allows the federal government to collect, analyze, and report on adverse reactions or other safety issues related to vaccines. It was created after the passage of the 1986 National Childhood Vaccine Injury Act and formally established in 1990. VAERS is jointly administered by the FDA and CDC.

VAERS is a “passive” surveillance system, as it depends on individuals submitting voluntary reports of issues that arise after vaccination. Anyone can submit reports to VAERS including healthcare providers, representatives from vaccine manufacturers, and the public. Since 1990, there have been over 2 million reports submitted to VAERS. Prior to 2020, there were on average about 40,000 to 50,000 reports submitted annually, and after COVID-19 vaccinations became available, the number of reports increased significantly, with over 1 million reports submitted in 2021 alone. FDA and CDC scientists monitor the VAERS database for possible signals of problems with vaccines. Most submissions report mild side effects after vaccinations, such as fever. Very rarely, more serious adverse events are reported and identified through VAERS. When staff at these agencies determine there may be a serious concern about a specific report or set of reports, additional information may be requested of the individual(s) that submitted the information such as clinical records or other evidence to corroborate the information in the report.

While anyone can submit to VAERS, which makes it easier and more convenient to report through this system, initial reports are not verified and, as with all passive surveillance, the population submitting reports to VAERS may not be representative of the population of people receiving vaccinations. Further, in some cases health issues reported by individuals following vaccination could be coincidental rather than causal. This is one reason additional information may be requested and further investigation triggered by serious VAERS reports. As a result, analyzing and interpreting VAERS data requires care and an understanding of its limitations. VAERS can be useful to generate hypotheses and indicate possible concerns but may not be suitable for determining definitive causal relationships between vaccines and safety issues. Because of these inherent weaknesses and difficulties working with VAERS data, some have used the data to draw misleading conclusions, or even actively misinform about links between vaccinations and adverse events. Regarding transparency, almost all data in VAERS is made public on the CDC website, including all initial and subsequent reports from the public. However, more sensitive follow-up information collected through VAERS during further review by federal officials is not made available due to privacy considerations.

Systems related to or similar to VAERS have been maintained at other federal agencies as well, including the Indian Health Service, the Department of Veteran’s Affairs, and the Department of Defense.

Vaccine Injury Compensation Data – HRSA

The Health Resources and Services Administration (HRSA) oversees the National Vaccine Injury Compensation Program (VICP). This program was one of several vaccine safety systems created by the 1986 National Childhood Vaccine Injury Act, and was designed to be a “no-fault alternative to the traditional tort system” for vaccine injury claims. Congress passed the 1986 law following a series of lawsuits against vaccine manufacturers and healthcare providers that had threatened the supply of vaccines in country. The system removes the liability burden from manufacturers for vaccine-related injuries, and allows for the government to compensate individuals and families affected by adverse reactions to childhood vaccinations. HRSA hosts the VICP, conducts medical reviews of submitted petitions, and makes any Court-ordered compensation payments to petitioners. The U.S. Court of Federal Claims is responsible for final decisions regarding whether compensation is warranted, and the amount and type of compensation from the government. Payments are funded through an excise tax on each dose of a childhood vaccine. To be included in VICP a vaccine must be: 1) recommended by the CDC for routine administration to children or pregnant women, 2) subject to the excise tax that funds VICP, and 3) must have been added to the official VICP Vaccine Injury Table by the Secretary of HHS. Each month, HRSA publishes an updated summary of claims and payouts, per covered vaccine, processed through the VICP. A total of 28,673 petitions have been filed with VICP between 1988 and 2025, and 12,019 (42%) were found to be compensable under the program. HRSA reports that over the period from 2006 to 2023, CDC estimates over 5 billion doses of VICP covered vaccines were distributed, and over the same time period 9,675 individuals were compensated for vaccine injuries, or about 1 compensable petition per 1 million doses distributed.

HRSA also oversees another injury compensation program, the Countermeasures Injury Compensation Program (CICP), initially created through the 2005 PREP Act. Like the VICP, the CICP provides compensation for adverse events following the administration or use of certain vaccines (along with diagnostics or other countermeasures). However, CICP differs from VICP in a number of important ways, such as: CICP only covers vaccines administered in the context of a public health emergency or security threat; CICP claims are adjudicated via an administrative process rather than a judicial process, and; there is no judicial appeals allowed under CICP (while VICP allows court-based appeals). Currently, COVID-19 vaccine injury compensation cases are evaluated and compensated under CICP rather than VICP, at least through December 2029 as presently authorized by Congress. HRSA provides monthly updates on CICP-related vaccine compensation cases and compensated amounts. According to this data, between fiscal years 2010 and 2025 CICP has received 14,413 claims and has reached a decision on 4,979 of those claims. 4,864 claims were denied, while 115 claims (or less than 1% of petitions) have been found to be eligible for compensation through June 2025.

While VICP and CICP compensation data do not constitute a traditional database or surveillance system for tracking vaccine safety, they can serve as an indicator of sorts for the scale and scope of vaccine injuries. However, not all vaccine injuries will be adjudicated through these systems, and there have been issues with delays in reaching decisions and settlements. In particular, the CICP’s more limited scope, administrative review process, and surge of claims related to COVID-19 vaccines since 2021 has led to long case review times. CICP also has a rejection rate that appears much higher than that of the VICP. Also, a re-organization of several HHS offices and agencies, including HRSA, has been announced by Secretary Kennedy, raising some questions about where these two compensation programs will reside and what support they will receive as part of the proposed “Administration for Health America” (AHA).

The Vaccine Safety Datalink (VSD) is an “active” vaccine adverse event surveillance program, created after the passage of the 1986 National Childhood Vaccine Injury Act and formally established by CDC in 1990. VSD is a collaboration between the CDC Immunization Safety Office and several health care system sites spread across various regions of the U.S. At its start, VSD worked with four sites, but the number of sites has expanded; CDC reports that there are presently 11 participating clinical sites (and two additional sites providing subject matter expertise), covering an estimated population of about 15 million health plan participants annually across all age groups, with an annual birth cohort of approximately 115,000 births.

VSD is designed to allow investigators to perform vaccine safety studies and investigate vaccine adverse events, drawing on data from the electronic health records (EHRs) of patients at participating sites. VSD investigators may include CDC and other federal government employees, as well as external experts. VSD data is used for active surveillance of vaccine safety issues through weekly analyses comparing rates of predefined adverse events following specific vaccines to rates in a comparison group. The data is also used to test hypotheses and perform more specific analyses or look further into potential vaccine-related adverse events identified in VSD or elsewhere. For data security and privacy reasons, since 2001 VSD EHR data is not centrally hosted by the federal government but rather decentralized across participating sites and held in secure servers. When needed, de-identified data from these sites can be shared with CDC for analysis.

VSD provides an ability to perform close to “real-time” surveillance of vaccine injuries drawing from a large national dataset, and also allows for deeper analyses on specific topics using historical data in VSD. Even so, VSD data may be limited when identifying or investigating extremely rare safety events. Because the data is decentralized across multiple institutions, coordinating and accessing a complete dataset for analysis is more cumbersome, but the structure also maintains privacy more effectively. As with other data sources relying on information from commercial insurers, it can be challenging to study medium- or long-term safety issues because patients frequently change insurance plans and health care providers.

Over the past several years, VSD has been a target of some criticism from anti-vaccine groups, which have raised concerns about supposed misuse of its data and a lack of transparency. During Senate hearings in May, HHS Secretary Kennedy said there have been “allegations of fraud” and “so much information that’s disappeared from [VSD].” However, there is no evidence this is the case, and current and former federal health officials familiar with VSD have pushed back on these statements. Recently, Kennedy appointed a controversial researcher to analyze VSD data to identify links between childhood vaccines and autism – even though that is a link disproven through many other studies across many years, including through published studies using VSD data.

V-Safe – CDC

V-safe is a vaccine safety monitoring system originally launched in December 2020 to help monitor the safety of COVID-19 vaccines. Subsequently, the system has also been used to track safety of mpox (starting in November 2022) and RSV vaccines (starting in May 2023). Currently, the system monitors for events following COVID-19 and RSV vaccinations across the U.S. (mpox monitoring has been discontinued). V-safe is a passive, voluntary system where recipients of monitored vaccines can report to CDC how they feel after being vaccinated. Individuals may choose to sign up with V-safe after their vaccination, and the system will send text or email messages asking questions about symptoms or side effects they may or may not be experiencing. The reported data is collected and kept confidential at CDC. If participants report experiencing serious side effects or adverse events following a vaccination, they may be prompted to complete a VAERS report as well.

V-safe data has been used in multiple studies of adverse events following COVID-19, mpox, and RSV vaccinations. De-identified data from V-safe is made public by CDC on its data download website.

While V-safe can provide CDC with timely snapshots of vaccine safety issues through its text/email-based reporting approach, it is a voluntary, opt-in system so the population reporting through V-safe may not be representative of the population receiving a particular vaccines. In addition, initial reports through V-safe are self-reported and not verified. Therefore, analyzing and interpreting V-safe data requires care and an understanding of its limitations. The data can be useful to generate hypotheses and indicate possible concerns, but may not be suitable for determining definitive causal relationships between vaccines and safety issues.

Clinical Immunization Safety Assessment (CISA) – CDC

The Clinical Immunization Safety Assessment (CISA) Project was established in 2001 by CDC. It is a national-level network of vaccine safety experts drawn from CDC, medical research centers, and other partners. Providers who have questions or concerns about vaccine safety can submit information to CISA and request a consultation with its experts, which is provided free of charge. For example, CISA experts can provide clinical case consultations that help answer complex vaccine safety questions regarding individual patients, conduct research on vaccine safety issues, and help providers and organization with responses to vaccine safety issues. CISA participants have authored many published articles on vaccine safety, drawing on this expertise and the inquiries submitted to CISA.

CISA is not a vaccine safety surveillance system per se, but rather, serves as a resource for clinicians and others around the country to draw on when complex or unfamiliar issues come up when evaluating vaccine injuries in patients. This resource can help speed the identification of issues that do arise, and provide expert context to investigations and analyses of vaccine safety. CISA does not provide a systematic database of analyses and results, but has a record of academic articles published that address a broad set of vaccine safety concerns.

Conclusion

Federal vaccine safety monitoring spans regulatory oversight during clinical trials, through to post-licensure surveillance systems that include tracking of population-level outcomes at a broad scale. It includes passive systems that rely on individuals to report vaccine adverse reactions and active systems that can tap into data in almost real-time to identify issues. No single system can comprehensively address all vaccine safety monitoring needs, but this combination of systems provides a foundation for tracking and understanding vaccine safety issues.

Even so, concerns have been raised about whether these systems are sufficiently robust, and recent statements from Trump Administration officials reflect a broader debate about whether and how these systems could be improved and whether additional steps need to be taken to assure the public about the safety of current vaccines. Already, we’ve seen concerns about safety used to justify changes to vaccine recommendations at FDA and CDC, even without new evidence that vaccines are unsafe. The extent to which such concerns will lead to changes in federal tracking and reporting on vaccine safety is unknown.

Key Characteristics of Federal Vaccine Safety Monitoring Systems