News Release

As State Medicaid Programs Prepare to Resume Disenrollments, Many States Are Using a Range of Strategies to Make it Easier for People Who Remain Eligible to Retain Coverage, But in Others it Will be More Difficult

Annual 50-State Survey Looks at Medicaid Eligibility, Enrollment, and Renewal Policies

Published: Mar 16, 2023

With pandemic-era protections for Medicaid enrollees set to expire this month, state Medicaid programs are gearing up to resume eligibility checks and disenrollments. But how the unwinding of the federal continuous enrollment provision affects enrollees and state budgets will vary according to states’ differing approaches and administrative capabilities, a new KFF survey finds.

The 21st annual KFF survey of state Medicaid and Children’s Health Insurance (CHIP) Program officials finds that many states are using an array of strategies to promote continuity of coverage, while other states have adopted policies that may make it harder for people who are still eligible to retain coverage. Staffing shortages and systems limitations could also affect whether eligible enrollees are able to remain enrolled.

The survey, conducted by KFF in collaboration with the Georgetown University Center for Children and Families, presents a snapshot of actions that states are taking to prepare for the unwinding of the provision that has paused Medicaid disenrollments since February 2020. It also highlights states’ Medicaid eligibility, enrollment, and renewal policies and procedures in place as of January 2023.

KFF has estimated that enrollment in Medicaid and CHIP will have grown by 23.3 million enrollees, to nearly 95 million, by the end of March when the continuous enrollment provision expires. Millions of beneficiaries are expected to be disenrolled over the next year, including some who are no longer eligible for Medicaid and others who still qualify but lose coverage due to administrative paperwork problems.

In the new survey, the one-third of states that were able to report projected coverage losses estimate that about 18 percent of Medicaid enrollees will be disenrolled after the continuous enrollment provision ends. The estimates range from seven percent to 33 percent of total enrollees and are consistent with other estimates that about 15 million people may lose Medicaid coverage over the coming year.

There is variation in the strategies states are adopting that could affect the amount of coverage losses, including:

  • Taking 12-14 months to complete renewals following the end of the continuous enrollment provision (43 states). Taking more time can help prevent inappropriate terminations of those who are still eligible but could maintain enrollment of ineligible people for longer.
  • Improving rates of renewals using ex parte processes that use reliable data sources — such as the Federal Data Services Hub and Supplemental Nutrition Assistance Program (SNAP) information — to verify ongoing eligibility, reducing the administrative burden on both states and enrollees (30 states).
  • Contacting enrollees when renewal action is needed and following up with those who don’t respond (36 states). About half of the states (27) have been flagging individuals who may no longer be eligible or who did not respond to renewal requests.
  • Adopting continuous eligibility policies for children, postpartum and for some adults that will help more people retain coverage during the unwinding. A total of 37 states have extended postpartum coverage to 12 months and 26 states provide 12-month continuous eligibility to some or all children in Medicaid and CHIP.

At the same time, some states have not adopted these strategies. Several states lack fully automated systems, processing some or most renewals manually (12 states) and others have ex parte renewal rates below 25 percent (11 states), which will increase the administrative burden on staff and enrollees. Even among states that adopt policies to promote continuity of coverage, implementation of policies and systems capacity will be key in how enrollees fare during the unwinding.

The challenge of processing an unprecedented volume of eligibility renewals and disenrollments comes at a time when most state Medicaid programs face significant staffing challenges. The survey finds that more than half of reporting states have staff vacancy rates greater than 10 percent for eligibility workers (16 of 26 reporting states) and slightly less than half for call center staff (13 of 28 reporting states).

These and other findings from the survey will be discussed today at a public web briefing. An archived video recording of the briefing will be available on kff.org later today.

The full survey report, “Medicaid and CHIP Eligibility and Enrollment Policies as States Prepare for the Unwinding of the Pandemic-Era Continuous Enrollment Provision,” includes state-level data about Medicaid and CHIP eligibility in every state. Also available are other recent KFF analyses related to the end of the continuous enrollment provision, including “Unwinding the Continuous Enrollment Provision: Perspectives from Current Medicaid Enrollees” and “Medicaid Enrollment Growth: Estimates by State and Eligibility Group Show Who may be at Risk as Continuous Enrollment Ends.

News Release

Annual Update of Key Health Data Collection by Race and Ethnicity, Now Including Mental Health Measures

Published: Mar 15, 2023

The annual update of KFF’s collection of wide-ranging data on health and health care by race and ethnicity is now available, and this year includes measures on mental health care access, mental illness, substance use disorder, suicide rates, and drug overdose death rates.

The handy reference, “Key Data on Health and Health Care by Race and Ethnicity,” has nearly 50 charts and up to 70 data measures that highlight the scale and scope of disparities among six racial and ethnic groups in three broad categories: health coverage and access to and use of care; health status, outcomes, and behaviors; and social determinants of health.

When the measures are examined collectively to see how Asian, Hispanic, Black, American Indian and Alaska Native (AIAN), and Native Hawaiian and Other Pacific Islander (NHOPI) people fare compared to White people, readers can see the extent of disparities experienced by specific groups. For example, Black people fared worse than White people in 55 measures of health and health care and Hispanic people fared worse than White people in 44 of them. However, the data may mask disparities faced by subgroups within these broad racial and ethnic categories. For example, while Asian people fare the same or better than White people on many measures, certain ethnic subgroups of Asian people may fare worse. Further, ongoing data gaps and limitations hinder the ability to have a comprehensive understanding of the experiences of smaller groups, such as AIAN and NHOPI people.

The overview of how specific racial/ethnic groups fared compared to White people is a gateway to explore the detailed findings, some of which have received attention or policy action recently:

  • Among adults with any mental illness, Black (39%), Hispanic (36%), and Asian (25%) adults were less likely than White (52%) adults to receive mental health services as of 2021.
  • 2020 data reflect that AIAN people had the highest rates of drug overdose deaths compared with all other racial and ethnic groups. Drug overdose death rates among Black people exceeded rates for White people as of 2020, reflecting larger increases among Black people in recent years.
  • Although Black people did not have higher cancer incidence rates than White people overall and across most types of cancer that were examined, they were more likely to die from cancer.
  • At birth, AIAN and Black people had a shorter life expectancy compared to White people as of 2021, and AIAN, Hispanic, and Black people experienced larger declines in life expectancy than White people between 2019 and 2021. These life expectancy trends may matter in any discussion of increasing the age of eligibility for Medicare.
  • Black infants were more than two times as likely to die as White infants, and AIAN infants were nearly twice as likely to die as White infants as of 2021. Black and AIAN women also had the highest rates of pregnancy-related mortality.

The Estimated Value of Tax Exemption for Nonprofit Hospitals Was About $28 Billion in 2020

Published: Mar 14, 2023

Editor’s note: This analysis was revised on March 27, 2023 to account for data anomalies and incorporate corrections, including to our estimate of the value of property tax exemption. These corrections result in a modest increase in the total estimated value of tax exemption, from $27.6 to $28.1 billion.

Over the years, some policymakers have questioned whether nonprofit hospitals—which account for nearly three-fifths (58%) of community hospitals—provide sufficient benefit to their communities to justify their exemption from federal, state, and local taxes. This issue has been the subject of renewed interest in light of reports of nonprofit hospitals taking aggressive steps to collect unpaid medical bills, including suing patients over unpaid medical debt, including patients who are likely eligible for financial assistance. Further, recent research indicates that nonprofit hospitals devote a similar or smaller share of their operating expenses to charity care in comparison to for-profit hospitals. In light of these concerns, several policy ideas have been floated to better align the level of community benefits provided by nonprofit hospitals with the value of their tax exemption.

This data note provides an estimate of the value of tax exemption for nonprofit facilities based on hospital cost reports, filings with the Internal Revenue Service (IRS), and American Hospital Association (AHA) survey data (see Methods for additional details). We define the value of tax exemption as the benefit of not having to pay federal and state corporate income taxes, typically not having to pay state and local sales taxes and local property taxes, and any increases in charitable contributions and decreases in bond interest rate payments that might arise due to receiving tax-exempt status. (For additional information, see Methods.)

Results

The total estimated value of tax exemption for nonprofit hospitals was about $28 billion in 2020 (Figure 1). This represented over two-fifths (44%) of net income (i.e., revenues minus expenses) earned by nonprofit facilities in that year. To put the value of tax exemption in perspective, our estimate is similar to the total value of Medicare and Medicaid disproportionate share hospital (DSH) payments in the same year ($31.9 billion in fiscal year 2020) (i.e., supplemental payments to hospitals that care for a disproportionate share of low-income patients which are intended, in part, to offset the costs of charity care and other uncompensated care).

The total estimated value of tax exemption for nonprofit hospitals was about $28 billion in 2020

The estimated value of federal tax-exempt status was $14.4 billion in 2020, which represents about half (51%) of the total value of tax exemption. This is primarily due to the estimated value of not having to pay federal corporate income taxes ($10.3 billion). In addition, we assumed that individuals contribute more to tax-exempt hospitals because they can deduct donations from their income tax base ($2.5 billion) and issue bonds at lower interest rates because the interest is not taxed ($1.6 billion). Our estimates of changes in charitable contributions and interest rates on bonds only account for federal tax rates for simplicity and may therefore understate the total value of tax exemption because they do not account for the effects of state taxes.

The total estimated value of state and local tax-exempt status was $13.7 billion in 2020, which represents about half (49%) of the total value of tax exemption. This amount includes the estimated value of not having to pay state or local sales taxes ($5.7 billion), local property taxes ($5.0 billion) or state corporate income taxes ($3.0 billion).

The total estimated value of tax exemption (about $28 billion) exceeded total estimated charity care costs ($16 billion) among nonprofit hospitals in 2020 (Figure 2), though charity care represents only a portion of the community benefits reported by these facilities. Hospital charity care programs provide free or discounted services to eligible patients who are unable to afford their care and represent one of several different types of community benefits reported by hospitals. TheInternal Revenue Service (IRS) also defines community benefits to include unreimbursed Medicaid expenses, unreimbursed health professions education, and subsidized health services that are not means-tested, among other activities. One study estimated that the value of tax exemption exceeded the value of community benefits broadly for about one-fifth (19%) of nonprofit hospitals during 2011-2018 or about two-fifths (39%) when considering the incremental value of community benefits provided relative to for-profit facilities. Other research suggests that nonprofit hospitals devote a similar or smaller share of their operating expenses to charity care and unreimbursed Medicaid costs—which accounted for most of the value of community benefits in 2017—when compared to for-profit hospitals.

The total estimated value of tax exemption (about $28 billion) exceeded total estimated charity care costs ($16 billion) among nonprofit hospitals in 2020, though charity care represents only a portion of the community benefits reported by these facilities

The value of tax exemption grew from about $19 billion in 2011 to about $28 billion in 2020, representing a 45 percent increase (Figure 3). The value of tax exemption increased in most of the years (7 out of 9) in our analysis, though there was a notable decrease of $5.8 billion in 2018. The largest single-year increase was $4.1 billion in 2020. The large decrease in the value of tax exemption in 2018 coincided with the implementation of the Tax Cuts and Jobs Act of 2017, which permanently reduced the federal corporate income tax rate from 35 to 21 percent and therefore decreased the value of being exempt from federal income taxes.

The value of tax exemption grew from about $19 billion in 2011 to about $28 billion in 2020, representing a 45 percent increase

The large increase in the value of tax exemption in 2020 overlapped with the start of the COVID-19 pandemic. This increase primarily reflects a large increase in aggregate net income for nonprofit hospitals in 2020. Although there were disruptions in hospital operations in 2020, hospitals received substantial amounts of government relief, and it is possible that other sources of revenue, such as from investment income, may have also increased. Increases in net income in turn increased the value of not having to pay federal and state income taxes.

Increases in the estimated value of tax exemption over time also reflect net income growth that preceded the pandemic as well as increases in estimated property values, supply expenses, and charitable contributions, each of which would carry tax implications if hospitals lost their tax-exempt status (e.g., with some supply expenses being subject to sales taxes). Even when setting aside the strong financial performance of nonprofit hospitals in 2020 as a potential outlier, total net income among nonprofit facilities increased substantially in the preceding years, before increasing further in 2020. Although we are not able to directly observe the value of the real estate owned by hospitals, the estimated value of exemption from local property taxes—which is based on our analysis of property taxes paid by for-profit hospitals—increased by 63 percent from 2011 to 2019. Finally, the supply expenses in our analysis increased by 44 percent and charitable contributions increased by 49 percent from 2011 to 2019.

Discussion

The estimated value of tax exemption for nonprofit hospitals increased from about $19 billion in 2011 to about $28 billion in 2020. The rising value of tax exemption means that federal, state, and local governments have been forgoing increasing amounts of revenue over time to provide tax benefits to nonprofit hospitals, crowding out other uses of those funds. This has raised questions about whether nonprofit facilities provide sufficient benefit to their communities to justify this tax benefit. Federal regulations require, among other things, that nonprofit hospitals provide some level of charity care and other community benefits as a condition of receiving tax-exempt status. However, a 2020 Government Accountability Office (GAO) report raised questions about whether the government has adequately enforced this requirement. Further, some argue that the federal definition of “community benefits” is too broad—e.g., by including medical training and research that could benefit hospitals directly—though others believe that the definition is too narrow. Most states have additional community benefit requirements for nonprofit or broader groups of hospitals—such as providing charity care to patients below a specified income threshold—though there is little information about the effectiveness of these regulations or the extent to which they are enforced.

Several policy ideas have been floated at the federal and state level that would increase the regulation of community benefits spending among nonprofit hospitals or among hospitals more generally. These include proposals to create or expand state requirements that hospitals provide charity care to patients below a specified income threshold, mandate that nonprofit hospitals provide a minimum amount of community benefits, establish a floor-and-trade system where hospitals would be required to either provide a minimum amount of charity care or subsidize other hospitals that do so, create mechanisms to increase the uptake of charity care, expand oversight and enforcement of community benefit requirements, replace current tax benefits with a subsidy that is tied to the value of community benefits provided, and introduce reforms intended to better align community benefits with local or regional needs. These policy options would inevitably involve tradeoffs. While they may expand the provision of certain community benefits, hospitals would incur new costs as a result, which could in turn have implications for what services they offer, how much they charge commercially insured patients, and how much they invest in the quality of care.

Methods

Our analysis defined the value of tax exemption as the benefit of not having to pay federal or state corporate income taxes, typically not having to pay state and local sales taxes and local property taxes, and any increases in charitable contributions and decreases in bond interest rate payments that might arise due to receiving tax-exempt status. To estimate the value of these benefits, we drew on methods from three studies and a report commissioned by the American Hospital Association (AHA). As is the case with prior work, we assumed that nonprofit hospitals and health systems would take various allowed deductions if they were required to pay taxes, but we do not capture all nuances of the tax code, nor do we model any other actions that hospitals take to reduce their tax burden, such as by changing how they operate or changing how they account for revenues and expenses. Two of the studies that we draw from estimated the total value of tax exemption or of federal tax exemption. Our estimates are smaller than these amounts, which likely reflects aspects of our approach that are more conservative than these papers. We detail our specific approach for each component below.

As a starting point, we relied on RAND Hospital Data, which applies cleaning and processing steps to annual cost report data submitted by hospitals to the Healthcare Cost Report Information System (HCRIS). Every Medicare-certified hospital must submit a cost report to a Medicare Administrative Contractor (MAC) under contract with the Centers for Medicare & Medicaid Services (CMS), meaning that HCRIS pulls data from all US hospitals except federal hospitals and some children’s hospitals. We used the calendar year version of RAND Hospital Data, which apportions data from different cost reports for hospitals that do not use a calendar year reporting period. For example, 2019 data reflect the weighted average of hospital finances during various periods from 2018 through 2020 (i.e., both before and during the COVID-19 pandemic) for a subset of hospitals. We excluded hospitals in the U.S. Territories and hospitals that did not report positive operating expenses in a given year (about 0.3% of remaining hospitals). We also relied on the AHA Annual Survey Database and IRS Form 990 data, focusing on hospitals and systems that we were able to match to RAND Hospital Data. We imputed values for supply expenses, charitable contributions, and tax-exempt bonds in instances where data were missing or unavailable for a given hospital or health system or year. We did not attempt to impute net income when missing (about 1.0% of remaining hospitals).

Federal corporate income tax. We estimated the federal corporate income tax that a given nonprofit hospital or health system would have to pay without the tax exemption by multiplying an estimate of taxable income by the federal corporate income tax rate, which was 35 percent from 2011 through 2017 but decreased to 21 percent in 2018. Our estimate of taxable income reflects the difference between revenues and expenses, accounting for deductions allowed under the federal tax code for interest rate payments, state corporate income taxes, state and local sales taxes, and local property taxes and adjusting for estimated changes in charitable contributions and bond interest rate payments. Hospitals may report unrealized gains or losses on financial instruments, which do not affect their tax base, as part of their net income. We aggregated hospital level data to the system level, as applicable, before estimating tax benefits. Aggregate estimates of tax benefits are lower when calculated at the system versus hospital level, as systems may be able to offset taxable profits from one system member with losses from another. We also modeled options for businesses to offset taxable income with losses in earlier and later years. Other studies have used an alternative approach that multiplies net income by estimates of effective tax rates based on tax filings from for-profit hospitals, nursing homes, and residential care facilities. Using this approach would have increased our estimates by $3.6 billion. We chose our approach because it is more closely tied to financial data from nonprofit hospitals.

State corporate income tax. We estimated the state corporate income tax that a given nonprofit hospital or health system would have to pay without tax exemption by multiplying an estimate of their taxable income in a given state by the state corporate income tax rate. We used a similar approach to estimating taxable income as above, except that we did not deduct the state corporate income tax (by definition) and we did not allow entities to offset taxable income with losses from later years, in line with state law. We obtained state corporate income tax rates by year from the Tax Foundation.

State and local sales taxes. We estimated the state and local sales taxes that a given nonprofit hospital or health system would have to pay without tax exemption by multiplying their total non-pharmaceutical supply expenses (or, for a system, the total supply expenses among member hospitals in a given state) by the average state and local sales tax rate in that state. We obtained total non-pharmaceutical supply expenses from the AHA Annual Survey Database. We obtained average state and local tax rates by state and year from the Tax Foundation.

Property taxes. We estimated the local property taxes that a given nonprofit hospital would have to pay without the tax exemption based on the amount paid by for-profit hospitals that reported this information. In the small number of states with five or more for-profit hospitals, we calculated the median ratio of property taxes to operating expenses among for-profit hospitals for a given state and year and then multiplied this amount by the operating expenses for a given nonprofit hospital. In states with fewer than five for-profit hospitals, we instead relied on the national median ratio among for-profit hospitals.

Charitable contributions. If nonprofit hospitals were no longer tax-exempt, donors who take itemized deductions for income taxes would no longer be able to deduct their contributions. We assumed that donors would decrease their contributions by an amount equal to their tax increase. We estimated this amount by multiplying charitable contributions by the estimated average household marginal tax rate of donors to health care organizations (32% from 2011 to 2017 and 23% from 2018 to 2020). Our 2011 to 2017 estimate of the marginal tax rate comes from a previous study. We updated this amount for 2018 to 2020 based on a Tax Policy Center estimate of the decrease in the average effective marginal tax rate for all donors in 2018 as a result of changes to the tax code. We estimated charitable contributions from Internal Service Revenue (IRS) Form 990 data by subtracting government grants and in-kind contributions from total contributions, gifts, grants, and other related amounts.

Bond interest rate payments. We assumed that, if interest rate payments from hospitals to bondholders were taxed, issuers would increase interest rates accordingly. We estimated the difference between taxable and non-taxable interest rates by: (1) estimating the average taxable interest rate using a rolling average of the Moody’s Seasoned Aaa and Baa index over the previous 10 years, (2) assuming a marginal tax rate for investors of 24 percent (based on a Capital Group post suggesting that municipal bonds are a better investment than taxable bonds for individuals with a marginal tax rate of 24% or higher), (3) assuming that average bond interest rates for nonprofit hospitals are equal to the after-tax bond interest rates among for-profit hospitals (so that investors are indifferent between the two), and (4) taking the difference. To estimate the value to a given hospital of paying lower interest rates, we multiplied the difference by the total value of tax-exempt bonds issued, which we obtained from IRS Form 990 data.

We used RAND Hospital Data to estimate charity care costs in 2020 based on amounts reported by the hospitals in our tax exemption analysis. HCRIS instructions indicate that hospitals should report amounts related to both their charity care and uninsured discounts as part of their charity care costs. After cleaning these data, we imputed values in instances where data were missing.

This work was supported in part by Arnold Ventures. KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities.

News Release

Nonprofit Hospitals’ Tax-Exempt Status Worth About $28 Billion, New KFF Analysis Finds

Published: Mar 14, 2023

Editor’s Note: The press release was updated on March 27, 2023, to reflect corrections in the underlying analysis, resulting in a modest increase in the total estimated value of tax exemption, from $27.6 to $28.1 billion.

The tax-exempt status of the nation’s nonprofit hospitals collectively was worth about $28 billion in 2020, a new KFF analysis of hospital financial data estimates.

The total reflects the estimated federal, state and local taxes that nonprofit hospitals do not have to pay. It also includes estimated increases in charitable contributions and decreases in bond interest rate payments due to hospitals having tax-exempt status.

Nearly three-fifths of the nation’s community hospitals are nonprofits, an Internal Revenue Service designation that requires hospitals to provide charity care and other benefits to their communities in exchange for federal tax-exempt status.

The $28 billion total is much higher than the $16 billion in free or discounted services provided by nonprofit hospitals in 2020 through their charity care programs, though charity care is just one element of the community benefits nonprofit hospitals provide. Other community benefits include unreimbursed expenses related to Medicaid and health professional education, and certain subsidized health services.

The Estimated Value of Tax Exemption for Nonprofit Hospitals Was About $28 Billion in 2020” is available as part of KFF’s expanding work examining the business practices of hospitals and other providers, and their impact on costs and affordability.

News Release

Challenges to the FDA’s Approval of Medication Abortion Pills Could Curtail Access Throughout the United States

Published: Mar 14, 2023

In anticipation of a ruling in a case with enormous implications for access to medication abortion in the United States, a new KFF brief explains the impact of this case, and others filed in federal courts, involving the FDA’s regulation of medication abortion. The case that has gotten the most attention recently is Alliance for Hippocratic Medicine (AHM) v. FDA, filed in November 2022, a challenge to the FDA’s decision to approve mifepristone (the first medication taken as part of the medication abortion drug regimen) and to include misoprostol in the medication abortion regimen. The outcome of AHM v. FDA, along with the other challenges, could have ramifications for access to medication abortion throughout the country, including in states where abortion is legal and protected. The outcome could also potentially have broader implications for the FDA’s authority in regulating drugs.

Read the brief, “Legal Challenges to the FDA Approval of Medication Abortion Pills,” which focuses on the major claims in the AHM case. Many of the issues raised in the brief will also be relevant to the other abortion cases involving the FDA and its role in approving and regulating mifepristone.

News Release

As Congress Considers Reauthorizing PEPFAR, A New Policy Watch Asks and Answers Fundamental Questions

Published: Mar 13, 2023

As Congress considers reauthorizing the President’s Emergency Plan for AIDS Relief (PEPFAR) for a fourth time, a new KFF Policy Watch details key facts about the program and top issues related to its authorization and funding. Created in 2003 as the U.S. government’s signature global health effort in the fight against HIV, PEPFAR is broadly regarded as one of the most successful programs in global health history, with the U.S. government reporting tens of millions of lives saved over the past 20 years. However, the reauthorization comes in a period of heightened debate over the federal budget in a divided Congress.

The Policy Watch asks and answers frequently asked, fundamental questions about PEPFAR’s reauthorization, including:

•    Will PEPFAR end without reauthorization?

•    Are there any provisions of the program that would end without reauthorization?

•    Is PEPFAR reauthorization required for the program to receive continued funding?

•    What are some issues to consider for PEPFAR’s future, and are these affected by reauthorization?

Read “PEPFAR Reauthorization 2023: Key Issues” and access a variety of resources about the program in our PEPFAR Policy Resource Hub

Legal Challenges to the FDA Approval of Medication Abortion Pills

Authors: Laurie Sobel, Alina Salganicoff, and Mabel Felix
Published: Mar 13, 2023

Key Findings

On June 13, 2024, the Supreme Court of the United States ruled in Alliance for Hippocratic Medicine (AHM) v. FDA that the AHM does not have standing to sue the FDA for injury. However, three state Attorneys’ Generals have intervened in this case in district court, and it is unclear how this action will shape the case when it goes back to the 5th Circuit Court of Appeals and then back to the originating federal district court.

Medication abortion has emerged as a major legal front in the battle over abortion access across the nation. Since the Supreme Court’s Dobbs ruling on June 24, 2022, four new cases have been filed in federal courts specifically regarding aspects of the FDA’s regulation of medication abortion. These challenges, some in the early stages, could affect the availability of abortion medications in the short and long term. At the heart of these cases is the FDA’s authority to approve drugs, whether courts can reverse the FDA’s decisions, and if states can impose additional restrictions beyond what the FDA requires. The case that has gotten the most attention recently is Alliance for Hippocratic Medicine (AHM) v. FDA, filed in November 2022, a challenge to the FDA’s decision to approve mifepristone, the first medication taken as part of the medication abortion drug regimen and to include misoprostol in the medication abortion regimen. The plaintiffs in this case contend the FDA did not act within its authority and that an 1873 anti-obscenity law, the Comstock Act, prohibits the mailing of any medication used for abortion.

The outcome of this case could have ramifications for access to medication abortion throughout the country, including in states where abortion is legal and protected. For the first time, the court is being asked to essentially overturn the approval of a drug, in this case one that has been safely used by more than 5.6 million people since it was approved in 2000 with a long record of safety and effectiveness. This issue brief focuses on the major claims in the AHM case, as a decision is expected soon, but many of the issues raised will also be relevant to the other abortion cases involving the FDA and its role in approving and regulating mifepristone.

Background on the FDA’s approval of Mifepristone

Mifepristone, often referred to as medication abortion pills, RU-486, or the abortion pill, was approved by the FDA over 20 years ago as a medication that can safely and effectively end pregnancy. A regimen of mifepristone, followed by misoprostol, a drug that is also used to treat ulcers, manage miscarriages, induce labor, and assist with IUD insertions, is an FDA approved protocol for abortion during the first 70 days, or up to 10 weeks, after the first day of the pregnant person’s last menstrual period. It is estimated that in 2020, medication abortions accounted for just over half of all abortions in the US. The drug regimen terminates pregnancies successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%). The FDA initially approved mifepristone with some conditions on who and how it can be dispensed in 2000, and over the years the FDA has amended these restrictions. (Appendix Table 1). The plaintiffs in the AHM case are challenging the FDA’s initial approval of mifepristone on procedural grounds, as well as the 2016, 2019 and 2021 changes to the drug’s safety program as being beyond the FDA’s authority.

Subpart H

When the FDA initially approved mifepristone, it did so under a provision called “Subpart H,” a set of regulations implemented to expedite the approval of “new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses,” like those to used treat HIV. The FDA approval process for mifepristone, however, was not expedited, as it was approved more than four years after the original application was filed. In the case of mifepristone, Subpart H was originally used to restrict the dispensing to prescribers who agreed to dispense it in certain health care settings, by or under the supervision of a qualified physician who attested to the ability to accurately date pregnancies and diagnose ectopic pregnancies. The drug was not available for distribution at retail pharmacies.

Risk Evaluation and Mitigation Strategy

The FDA Amendments Act of 2007 (FDAAA) added a new section (Section 505-1) to the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizing the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) for a drug if the FDA deems it is necessary to ensure that the drug’s benefits outweigh its risks; it also revises the terminology for eligibility for the drug from treating a “serious or life threatening illness” to permitting the FDA to require a REMS for drugs intended to be used for a “disease or “condition.”

Congress also deemed all drugs with existing restricted-distribution programs (Section 909 of the FDAAA), including mifepristone, to require a REMS. Congress required sponsors of such “deemed” drugs to submit a proposed REMS to the FDA — which mifepristone’s sponsor did. The FDA approved the initial REMS for mifepristone in 2011, which required in-person dispensing by or under supervision of a certified physician, the dispensing of misoprostol at the provider’s office or clinic, and a follow-up visit 14 days later. In 2016, the FDA updated and approved a new evidence-based regimen and drug label for mifepristone. This updated regimen expanded the use of the mifepristone/misoprostol regimen from 49 days to up to 70 days (10 weeks) of pregnancy. In addition, the provider certification requirement was broadened from being limited to physicians only to include other advanced practice clinicians (e.g., nurse practitioners and physician assistants) who can meet the REMS requirements. The FDA approved the generic version of mifepristone in 2019 and issued a unified REMS for both the generic and the brand-name medication. In April 2021, the FDA decided to exercise enforcement discretion for the in-person dispensing requirement during the public health emergency. In December 2021, when the FDA rejected the plaintiffs’ citizen petition, the FDA removed the in-person dispensing requirement for mifepristone and expanded the distribution to include certified pharmacies in addition to certified clinicians. On January 3, 2023, the FDA updated the REMS approving the protocol for certification of pharmacies, allowing those that have been certified by the manufacturers to dispense mifepristone directly to patients (eliminating the requirement that it can only be dispensed directly to the patient by the certified provider).

In the case, Alliance for Hippocratic Medicine v. FDA, (filed November 18, 2022 in the US District Court for The Northern District of Texas Amarillo Division presided over by a Trump Administration appointed judge), the plaintiffs are challenging the FDA’s approval of mifepristone on many grounds. (Table 1) The plaintiffs are the Alliance for Hippocratic Medicine (a newly formed anti-abortion advocacy coalition); the American Association of Pro-Life Obstetricians and Gynecologists; the American College of Pediatricians; and the Christian Medical and Dental Associations, as well as three individual doctors (Shaun Jester, D.O., Regina Frost-Clark, M.D., Tyler Johnson, D.O., and George Delgado, M.D.)

As with any lawsuit, the plaintiffs first need to show they have legal standing by demonstrating they have an injury, and that they have filed this action within six years of the FDA’s action, the statute of limitations.

Do the plaintiffs have standing?

The plaintiffs, the Alliance for Hippocratic Medicine, the AAPLOG, the American College of Pediatricians and the Christian Medical & Dental Associations, contend that they have members in Texas and around the country who have treated and will continue to treat women and girls who have experienced a complication from medication abortion. In addition, the associations assert that they have suffered organizational harms from the FDA’s approval of mifepristone because they have spent time and resources to conduct their own studies and analysis, and to educate their members about the dangers of medication abortion. Anyone challenging the actions of a federal agency must demonstrate that they are within the “zone of interests” protected or regulated by the statute in question. The plaintiffs contend that they are within the FDCA’s zone of interests, meaning their interests are protected by the statute. The plaintiffs who are individual doctors are suing on their own behalf and on behalf of their patients, citing that the Supreme Court has held that medical providers have third-party standing to invoke the rights on their patients. Interestingly, in his dissenting opinion for June Medical Services v. Russo, Justice Alito called into question the precedent that allowed abortion providers to challenge abortion restrictions on behalf of their patients.

The Government argues that none of the plaintiffs have established an injury-in-fact or that they are within the “zones of interest,” which is necessary to establish standing. While the plaintiffs are not regulated by the FDA and do not prescribe mifepristone, the plaintiffs claim they will have to treat patients who suffer from complications from mifepristone and therefore have less time and resources to treat other patients. The Government argues this reasoning is speculative. Furthermore, they claim this approach to standing could open the door for any doctor to challenge the FDA’s approval of any drug that causes adverse events.

Have the plaintiffs filed this lawsuit within the statute of limitations?

There is a six-year statute of limitation to challenge any federal agency action. Anyone challenging an agency action is also required to exhaust their administrative remedies before initiating litigation seeking judicial review. FDA regulations specifically require challengers to file a “citizen petition” before any legal action can be filed in a court. In 2019 the plaintiffs filed a citizen petition asking the FDA to undo a 2016 revision of the REMS for mifepristone, which had changed the gestational limit for taking the drugs from 49 days to 70 days (10 weeks), expanded the provider certification requirement beyond physicians to include advance practice clinicians (e.g. nurse practitioners and physician assistants), and eliminated the requirements for in-person administration of misoprostol and for an in-person follow-up examination. The Government’s position is that the statute of limitations bars the plaintiffs from raising any issues not included in their 2019 citizen petition. This petition did not contest the underlying approval of mifepristone established in 2000. The plaintiffs maintain that the statute of limitations resets every time the FDA has modified the restrictions for mifepristone.

WHAT ARE THE PLAINTIFFS’ CLAIMS?

If the plaintiffs make it through these two hurdles, they are challenging the FDA’s approval and subsequent modifications of the dispensing requirements for mifepristone as being beyond the FDA’s authority based on the FFDCA statute. The plaintiffs are asking the court to find the FDA acted beyond its authority to initially approve mifepristone using Subpart H and that the FDA’s initial approval and subsequent actions to regulate mifepristone were not supported by sufficient evidence of safety and efficacy. The plaintiffs have cited their own studies to reach their conclusion that mifepristone is not safe. It is an unprecedented request to ask a court to block the FDA’s prior determination that a drug is safe and effective (Table 1).

Table 1: Summary of the Plaintiffs’ and the Government’s Positions

Alliance for Hippocratic Medicine v. FDA

Claim: FDA’s approval of mifepristone in 2000 violated the Administrative Procedures Act (APA) because the FDA Lacked the authority to use subpart H
Plaintiffs’ Position:
  • The FDA fast tracked the initial approval of mifepristone.
  • The use of Subpart H was not proper because pregnancy is not an illness.
Government’s Position:
  • FDA’s original approval of mifepristone, which occurred more than four years after the new drug application was submitted to the agency did not involve an ‘’accelerated review.”
  • The preamble to Sub-part H regulation makes clear that it was intended to be used for “conditions” as well as illnesses.
  • FDA extensively reviewed the scientific evidence and determined the benefits of mifepristone outweigh any risks.
  • FDA relied on Subpart H to place certain restrictions on the manufacturer’s distribution of the drug product to assure its safe use.
Claim: The FDA’s approval of and subsequent actions to regulate mifepristone were not supported by sufficient evidence of safety and efficacy and did not meet federal pediatric assessment requirements, violating the APA and Federal Food, Drug and Cosmetic Act
Plaintiffs’ Position:
  • The FDA’s initial approval and subsequent actions to regulate were not supported by sufficient evidence.
  • The FDA did not consider the impact on the pediatric population.
  • The FDA’s denials of two citizen petitions were unreasonable and not supported by the administrative record.
Government’s Position:
  • FDA extensively reviewed the scientific evidence and determined the benefits of mifepristone outweigh any risks.
  • The FDA’s conclusion that studies in pediatric patients were not needed is consistent with the pediatric rule regulations.
  • The FDA’s determinations are entitled to significant deference.
  • The FDA denied the citizen petitions based on its scientific review of the evidence clearly demonstrating mifepristone’s safety and efficacy.
Claim: The FDA’s approval of mifepristone and subsequent modifications violated the Comstock Act.
Plaintiffs’ Position:
  • This act should be read literally to prohibit the mailing of any drug used to terminate an abortion.
Government’s Position:
  • The plaintiffs are barred from raising this issue because they failed to raise it in the administrative proceedings.
  • This law has been amended by court precedents and administrative actions and does not apply to mailing abortion drugs when the sender has no reason to believe they will be used unlawfully.

Does the Comstock Act impede the distribution of abortion medications?

When the Comstock Act was passed in 1873, it made it illegal to send “obscene, lewd or lascivious,” “immoral” or “indecent” publications or other materials through the mail. It also banned the mailing of any articles that could be used as contraceptive or to cause abortions. The plaintiffs in this case contend that the Comstock Act should be read literally. The plaintiffs cite a section of the Act as prohibiting the mailing or delivery by any letter carrier of “[e]very article or thing designed, adapted, or intended for producing abortion” and “[e]very article, instrument, substance, drug, medicine, or thing, which is advertised or described in a manner calculated to lead to another to use or apply it for producing abortion, ” and a separate section as prohibiting the use of “any express company or other common carrier” to transport abortion drugs in interstate or through foreign commerce. They are seeking to block the distribution of drugs for abortion (mifepristone and misoprostol) to clinics, doctors, and hospitals, as well as to patients, on grounds that the Comstock law makes it illegal to send these through the mail or other carriers.

However, the Government contends that because the plaintiffs failed to raise the Comstock argument at any stage of the administrative proceedings, they are therefore barred from raising it now. In addition, the Government contends that the plaintiffs’ Comstock argument fails on the merits. Although Congress has not amended the abortion provisions in the statute, prior court cases and administrative actions have limited the reach of the Comstock Act. In December 2022, the US Department of Justice’s Office of Legal Counsel issued an opinion, concluding that the Comstock Act does not prevent the mailing of medication for abortion for legal use.

Possible Rulings and Implications

Depending on the ruling, the case could affect the availability and distribution of mifepristone. More broadly, if the court allows the plaintiffs to have standing, the door may be opened for future litigation brought by doctors and organizations challenging the FDA’s approval of other drugs. Similarly, if the court does not restrict the plaintiffs’ challenges to what they included in their 2019 citizen petition, then other litigation may be brought beyond the six years statute of limitation period that challenges agencies’ actions without first exhausting administrative remedies.

Possible Ruling 1: FDA Approval of Mifepristone Violated the APA

The federal court could find that the FDA did not apply a lawful review process for its initial approval of mifepristone in 2000. It would be unprecedented for a Court to rule that the FDA did not properly approve a drug, much less one that has a safety and effectiveness record over more than two decades. While the availability of mifepristone for abortion could be blocked following such a ruling, it is likely, based on the research, record and clinical trials, that the drug would be reapproved by the FDA. This would, however, force those who seek abortion to use a less effective medication abortion protocol with misoprostol only in the interim. The court could also rule that the FDA acted beyond its authority by including misoprostol in the two-drug regimen for medication abortion. However, because misoprostol is currently used for medication abortion off-label, it is not clear how this ruling would impact the availability of misoprostol.

If the court suspends the FDA’s approval of mifepristone, with or without finding that the FDA acted improperly by including misoprostol, clinics will likely respond by switching to using a higher dose of misoprostol alone, but that is less effective (estimated to be between 80% and 100% effective) than using mifepristone and misoprostol together (99% effective). Misoprostol along can also cause more side effects, including pain and bleeding than the combination regimen. In addition, patients experiencing a miscarriage will also need to switch to using only misoprostol. This ruling will likely have implications far beyond abortion. This action would open the door for other actors to potentially sue to block the approval of existing or new drugs that may be deemed as controversial such as vaccines or treatments for conditions that are at the crosshairs of culture wars. Manufacturers may be reluctant to bring to market certain new drugs or treatments if they are concerned that a court ruling could block the approval of the drug in the future.

Possible Ruling 2: FDA 2016 Revision of the REMS Violated the APA

The court could limit the plaintiffs’ arguments to those they included in their 2019 citizen petition, which challenged changes to the conditions of use and restrictions on the distribution of mifepristone. The 2019 petition asked the FDA to “[r]etain” the 2011 REMS and its in-person dispensing requirement, and to “restore and strengthen elements of the [mifepristone] regimen and prescriber requirements approved in 2000” to: (1) limit mifepristone’s use to 49 days gestation; (2) require the drug to be administered by or under the supervision of a physically present and certified physician who has ruled out ectopic pregnancy; (3) require three office visits; (4) include a contraindication for patients who do not have convenient access to emergency medical care; (5) require reporting of certain adverse events to FDA; and (6) require additional studies If the court grants the plaintiffs’ request to roll back the requirements for the gestational age for which the regimen is approved and limit the pool of clinicians who could be certified to dispense the drug therefore constraining abortion access for those in states that have not banned abortion. This would effectively eliminate the new evidence-based protocols the FDA has established which removed the in-person dispensing requirement, permitted telehealth abortions, and established the process for pharmacies to become certified to dispense mifepristone.

Possible Ruling 3: The Comstock Act Blocks Distribution of Medication Abortion Pills

If the court rules in favor of the plaintiffs finding that the Comstock Act prohibits the mailing of mifepristone and misoprostol, the distribution channels for both drugs could be effectively shut down, and access to the drugs will become limited over time. This would affect not only the mailing of the drug to patients through telemedicine but could also limit the distribution of the medication to hospitals, clinics or clinicians. Misoprostol is used to treat ulcers, and mifepristone is used to treat Cushing’s Syndrome. Both drugs are used for miscarriage management. Patients who need these drugs ,for these conditions, many of whom are women, could potentially have limited or no access. If the court ruling relies narrowly on the Comstock Act, there would not likely be broader ramifications for the FDA’s authority to regulate other drugs and be limited to medication abortion. It is conceivable that if it reaches the Supreme Court on appeal, the Court could leave intact the FDA’s current authority to review and approve drugs, but rule in favor of the plaintiffs, based on the Comstock Act reasoning that it’s the responsibility of Congress, not the Court’s, to repeal the Comstock Act if it’s no longer valid. This ruling could create large barriers for patients to access medication abortion across the country, even in states where abortion is legal. Even if the ruling does not find that the FDA’s approval of mifepristone was improper, a ruling based on the Comstock Act would severely limit distribution of the mifepristone and misoprostol.

Other Cases Involving the FDA and Medication Abortion

While many have focused on the AHM case, there are several other cases in the federal court system that relate to aspects of the FDA’s regulation of mifepristone. Now that states are permitted to ban abortion, new questions have arisen regarding the intersection of federal and state authority when it impacts access to abortion.

Federal law preempts state law, but some are questioning how the new state authority to regulate or ban abortion intersects with the Federal FDA’s authority to regulate drugs. There are currently two cases in federal court challenging state abortion prohibitions and restrictions on federal preemption grounds. The maker of a generic mifepristone medication, GenBioPro, Inc., is challenging West Virginia’s total abortion ban, and an ob-gyn, Dr. Amy Bryant, is challenging the abortion restrictions in North Carolina, which include requirements that mifepristone be dispensed in person by a physician following a state-mandated counseling session and a 72-hour waiting period. In both cases, plaintiffs argue that the FDA’s authorization and regulation of mifepristone preempt state law banning the use of the medication or regulating its use more strictly, and given this, enforcement of the state laws should be blocked. If these lawsuits are successful, people living in states where abortion is banned could access medication abortion.

In addition, the Oregon and Washington Attorneys General joined by 10 other Attorneys General are also challenging the FDA’s decision-making about mifepristone. but rather than challenging the FDA approval process, the plaintiffs are calling to question the FDA’s decision to impose restrictions on prescribing and dispensing mifepristone through the Risk Evaluation and Mitigation System (REMS). The case filed by the Oregon and Washington Attorneys General in the US District Court in the Eastern District of Washington could result in a conflicting ruling from the AHM case. Ultimately, the Supreme Court could decide the role of the courts to review the FDA’s decisions, and how much deference the agency should be given.

Conclusion

No matter how the district court rules in the AHM case, the parties will likely appeal to the 5th Circuit Court of Appeals and then to the Supreme Court. The case, as well as others about medication abortion, raise questions about the role of the courts in reviewing the FDA’s findings about a particular drug. While most of the focus since the Dobbs ruling has been on the impact of that ruling on those who live in states that ban or greatly restrict abortion, the outcome of these medication abortion cases could also affect the availability of medication abortion to people in who live in states that protect abortion access. Furthermore, these cases could also have far-reaching implications for the FDA’s authority to continue to regulate not only mifepristone, but a wide range of other drugs that could be perceived to be controversial today and in the future.

Appendix

Appendix

Appendix Table 1: Timeline of Regulatory Actions Regarding Mifepristone*
DateAction
March 1996The Population Council submitted a New Drug Application (NDA) for Mifeprex (Mifepristone).
September 2000FDA approved Mifeprex for the medical termination of pregnancy through 49 days’ gestation. The approval was granted under FDA’s regulations at 21 C.F.R. Part 314 Subpart H (Subpart H), which permitted FDA to impose conditions the agency deemed necessary to ensure the product’s safe use, including in this instance requirements regarding the capabilities and commitments of each healthcare provider who would be authorized to prescribe the drug and restrictions on how the drug would be distributed.
August 2002American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and Christian Medical& Dental Associations and Concerned Women for America submitted a citizen petition requesting FDA revoke approval of Mifeprex.
September 2007Congress amended the Food, Drug, and Cosmetic Act to give FDA authority to require an applicant to submit a risk evaluation and mitigation strategy (REMS) if the agency determined that a REMS “is necessary to ensure that the benefits of the drug outweigh the risks of the drug.” 21 U.S.C. § 355-1(a)(1).
August 2008The GAO issued a report on the approval and oversight of Mifeprex following a request from several members of Congress.
June 2011FDA approved the Mifeprex REMS after Danco submitted an application on September 17,2008. The approved REMS maintained and augmented the Subpart H requirements imposed with the initial approval of Mifeprex.
March 2016FDA denied the 2002 citizen petition requesting to revoke approval of Mifeprex.
March 2016FDA updated and approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy.
March 2018The GAO issued a report on FDA’s actions in approving the 2016 changes following a request from several members of Congress.
March 2019Plaintiffs AAPLOG and ACOP submitted a citizen petition to FDA asking the agency to “restore and strengthen elements of the Mifeprex regimen and prescriber requirements approved in 2000,” and “retain the Mifeprex [REMS], and continue limiting the dispensing of Mifeprex to patients in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.”
April 2019FDA approved of GenBioPro’s abbreviated new drug application for a generic version of mifepristone. FDA determined that the generic drug was material the “same” as Mifeprex. With this approval, the FDA also approved a Mifepristone REMS program, covering both Mifeprex and the generic medication.
April 2020The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) sent a letter urging FDA to suspend enforcement of the in-person dispensing requirements of the Mifeprex REMS.
April 2021FDA responded to the letter from ACOG and SMFM, stating that during the COVID-19 public health emergency, the agency would exercise enforcement discretion with regard to “dispensing of Mifeprex . . . through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.”
May 2021FDA updated the Mifepristone REMS, adding gender-neutral language to the patient agreement form.
December 2021FDA responded to the 2019 citizen petition from plaintiffs AAPLOG and ACOP, addressing in detail their concerns, assertions, and the sources cited in support, but denying their request to restore the requirements approved in 2000 and to limit dispensing (for both Mifepristone and Misoprostol) in person.
January 2023FDA modified the Mifepristone REMS, removing the in-person dispensing requirement.
NOTES: *For the purpose of terminating pregnancy. The FDA has additionally approved a Mifepristone medication to treat Cushing’s disease.

PEPFAR Reauthorization 2023: Key Issues

Published: Mar 13, 2023

This year, Congress will consider reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR), which was created in 2003 as the U.S. government’s signature global health effort in the fight against HIV. This would be PEPFAR’s fourth reauthorization. The program is broadly regarded as one of the most successful programs in global health history, with the U.S. government reporting tens of millions of lives saved over the past 20 years. Our analyses have also found positive spillover effects associated with the program beyond HIV, such as large, significant reductions in both maternal and child mortality and significant increases in some childhood immunization rates. At the same time, with a divided Congress, there are likely to be heightened disagreements over funding levels across the federal budget, potentially tied to the need to raise the debt ceiling later this year.

Following are fast facts about the program and top issues related to PEPFAR’s authorization and funding.

Fast Facts About PEPFAR

  • Created in 2003 during the George W. Bush administration
  • FY 2023 funding: $6.9 billion, with approximately $4.9 billion for bilateral HIV efforts and $2 billion for U.S. contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria
  • Spans more than 50 countries
  • Reports saving 25 million lives
  • Operates largely under permanent authorities of U.S. law that allow for ongoing funding and the continuation of the major structures of the program
  • Would continue absent a reauthorization, provided funds are appropriated (although some time-bound requirements would end if a reauthorization bill is not passed or if Congress does not address them through another legislative vehicle)

What are authorization and reauthorization bills, and what is their connection with appropriations bills?

Established by House and Senate rules, the two-step process of authorization/appropriations supports the linkages between the authorizing and appropriating committees of each chamber:

  • Authorization legislation establishes programs, policies, and organizational, oversight, and reporting requirements. It is also “intended to provide guidance to appropriators as to a general amount and under what conditions funding might be provided to an agency or program” before appropriations may be made. It may have time-limited provisions, including for funding.
  • Reauthorization legislation allows existing law for programs and policies to be adapted to current circumstances, such as adding or updating reporting requirements, increasing oversight, and extending or modifying time-limited provisions.
  • Appropriations legislation provides budget authority, allowing funding for an agency or program.

For foreign assistance specifically – including global health assistance – this two-step process is also required by law. Still, this requirement is often waived by Congress since it has not passed comprehensive foreign assistance authorization legislation since 1985. (Some instances of limited authorization legislation for specific programs, including global health programs such as PEPFAR, exist, but these are less frequent occurrences than the use of waivers for the process.) Thus, absent an authorization or reauthorization bill, an appropriations bill can have the effect of authorizing the creation of a new program when providing funding for a specific activity for the first time and/or authorizing the continued operation of an existing program by providing continued funding for its activities.

When was PEPFAR created, and how many times has it been reauthorized?

President George W. Bush called for the creation of a new U.S. global HIV program in his State of the Union address on January 28, 2003, and Congress passed authorizing legislation just four months later on May 23, 2003. This legislation established the program, its structure – including creating a new position of U.S. Global AIDS Coordinator at the Department of State, with the rank of Ambassador – and initial funding authorization levels. Since then, PEPFAR has been reauthorized three times (see Table 1).

Table 1: PEPFAR Legislation
Full TitleCommon TitlePublic Law #YearsFunding Authorization Level
United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003“The Leadership Act”P.L. 108-25FY 2004 – FY 2008$15 billion
Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008“The Lantos-Hyde Act”P.L. 110-293FY 2009 – FY 2013$48 billion
PEPFAR Stewardship and Oversight Act of 2013“The PEPFAR Stewardship Act”P.L. 113-56FY 2014 – FY 2018Did not specify authorization for funding
PEPFAR Extension Act of 2018“The PEPFARExtension Act”P.L. 115-305FY 2019 – FY 2023Did not specify authorization for funding
NOTES: Current law is reflected in the consolidation of PEPFAR authorizing legislation in U.S. Code: 22 USC Chapter 83: United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria.

Will PEPFAR end without reauthorization?

No. PEPFAR operates largely under permanent authorities of U.S. law that allow for ongoing funding and the continuation of the major structures of the program, such as the Office of the Global AIDS Coordinator at the Department of State as well as the position of Global AIDS Coordinator, U.S. participation in the Global Fund, and annual reporting on PEPFAR efforts. Absent a reauthorization, the PEPFAR program would continue, provided funds are appropriated. There are, however, some requirements that are time-bound and would “sunset” if a reauthorization bill is not passed (Congress could, for example, simply extend the dates of these time-bound provisions in a reauthorization bill) or if Congress does not address them through another legislative vehicle. Specifically, there are seven requirements that would end after FY 2023, and one that would end after FY 2024, if not addressed. Of these, two relate to how HIV funding is allocated, four specify requirements related to the U.S. contribution to the Global Fund, and two address reporting or oversight (see Table 2).

Table 2: PEPFAR Legislation – Expiring Time-Bound Provisions
Topic of ProvisionDescription
1.   HIV Bilateral Funding Allocation: Treatment, Care, Nutrition and Food SupportRequires that more than half of funds appropriated or otherwise made available for bilateral HIV be expended for treatment, care, and nutrition and food support for people living with HIV (through FY 2023)
2. HIV Bilateral Funding Allocation: Orphans and Vulnerable Children (OVC)Requires that not less than 10% of funds appropriated or otherwise made available for bilateral HIV be expended for programs targeting orphans and other children affected by, or vulnerable to, HIV (through FY 2023)
3.   Global Fund Contribution: 1/3 CapLimits U.S. contributions to the Global Fund to not exceed 33% of all funds donated to the Global Fund during a specified period (“1/3 cap”) (through FY 2023, calculated from FY 2004)
4.   Global Fund Contribution: Use of Funds Withheld Due to 1/3 CapAuthorizes that any of the U.S. contribution to the Global Fund withheld due to the 1/3 cap may be used for bilateral HIV, TB, and malaria programs (through FY 2023)
5.   Global Fund Contribution: Withholding Obligation of 20% Pending CertificationRequires withholding 20% of annual U.S. contribution to the Global Fund pending certification of certain accountability and transparency benchmarks by the Secretary of State* (through FY 2023)
6.   Global Fund Contribution: Withholding Portion if Funds Expended to Certain GovernmentsRequires withholding a portion of the U.S. contribution to the Global Fund, the next fiscal year, equal to the amount expended by the Global Fund to country governments determined by the Secretary of State to have “repeatedly provided support for acts of international terrorism” (through FY 2023)
7.   Annual Treatment Providers StudyDirects the Global AIDS Coordinator to annually complete a study of treatment providers for HIV programs, including spending by the Global Fund and partner countries (through FY 2024)
8.   Oversight Plans of Inspectors General Directs various agencies’ inspectors general to jointly develop coordinated annual plans for overseeing HIV, malaria, and TB programs (through FY 2023)
NOTES: * In certain years, Congress directed the withholding to be 10%, rather than 20%.SOURCE: KFF, PEPFAR Reauthorization: Side-by-Side of Legislation Over Time.

Is PEPFAR reauthorization required for the program to receive continued funding?

No. Under current legislative rules, Congress can continue to appropriate funding for the program each year. As mentioned above, typically, reauthorization and appropriation bills work hand-in-hand, though there are exceptions, such as authorized programs that do not have a current funding authorization but for which funding is effectively authorized when it is appropriated (as has been the case for PEPFAR since FY 2014). At the same time, the House of Representatives recently passed a rules package for the 118th Congress that requires authorization and oversight plans for House committees, which may signal heightened oversight as well as more visibility around, and potential discussion of, the practice of appropriating funding to programs without a current funding authorization.

Does a funding authorization signal a required level of funding?

When included in an authorization or reauthorization bill, a funding authorization may indicate congressional intent to appropriate funding at certain levels, but Congress is not required to appropriate the level of funding that is authorized for a discretionary program. Ultimately, Congress may appropriate more funding than authorized in some instances, while it may appropriate less in others. This happened during PEPFAR’s first five-year authorization, FY 2004 – FY 2008, when more was appropriated than the $15 billion initially authorized ($19.8 billion was appropriated). The reverse happened during the its second period, FY 2009 – FY 2013, when less was appropriated than the $48 billion authorized (just under $37.2 billion was provided).

A funding reauthorization in PEPFAR for an area (e.g., bilateral HIV) or purpose (e.g., U.S. contribution to the Global Fund) may be a specific funding amount – either as an exact amount that indicates Congress wants that amount directed to this, as a floor that indicates Congress wants at least this amount directed to this, a ceiling that indicates Congress wants no more than this amount directed to this – or more general, stating “such sums as necessary” are authorized for this (this amount may be within an overall funding authorization level or may be standalone).

What are some issues to consider for PEPFAR’s future and are these affected by reauthorization?

Regardless of what happens with reauthorization, there are several discussions underway and questions about PEPFAR’s future that are not dependent on the program’s reauthorization (though Congress could choose to address them that way). Among others, these include discussions about PEPFAR’s role in pandemic preparedness and response, particularly given its work to address COVID-19 in PEPFAR countries and the numerous global challenges ahead for shoring up pandemic preparedness more generally. Indeed, in December 2022, the Secretary of State announced plans for a new Bureau of Global Health Security and Diplomacy that would bring together the functions of several Coordinators and offices, including PEPFAR’s Office of the U.S. Global AIDS Coordinator and Global Health Diplomacy and the Coordinator for Global COVID-19 Response and Health Security. The Bureau would be led by the Department of State official who is already dual-hatted as the U.S. Global AIDS Coordinator and the U.S. Special Representative for Health Diplomacy, currently Dr. John Nkengasong. There are also broader questions about how PEPFAR, and other vertical disease programs (those focused on single diseases), can best contribute to making health systems stronger and more sustainable at the country level; how, with what has largely been flat funding, the program can make further gains in the HIV response; and how best to promote equity, particularly regarding key and other vulnerable populations.

Global Health Funding in the FY 2024 President’s Budget Request

Published: Mar 10, 2023

President Biden released the FY 2024 President’s Budget Request on March 9, 2023. The request includes discretionary funding for U.S. global health programs at the State Department, the U.S. Agency for International Development (USAID), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). Funding provided to the State Department and USAID through the Global Health Programs (GHP) account, which represents the bulk of global health assistance, totals $10.9 billion, an increase of $367 million above the FY 2023 enacted level. Most of the increase is for global health security (GHS), which totals $1.2 billion (an increase of $345 million above the FY 2023 enacted level) and includes $500 million for the Pandemic Fund. Funding also increased for family planning and reproductive health (FP/RH), Gavi, and the Health Reserve Fund, but is lower for bilateral HIV, tuberculosis (TB), and malaria. The FY 2024 request also includes new dedicated funding for the Global Health Worker Initiative. Funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), maternal and child health (MCH), nutrition, vulnerable children, and neglected tropical diseases remained flat. See the table below for additional detail on global health funding in the FY 2024 request (downloadable tables here). See the KFF budget tracker for details on historical annual appropriations for global health programs.

Table: KFF Analysis of Global Health Funding in the FY24 President’s Budget Request
Department / Agency / AreaFY23 Omnibus(millions)FY24 Request(millions)Difference:FY24 Request – FY23 Omnibus
State, Foreign Operations, and Related Programs (SFOPs) – Global Healthi
HIV/AIDSii
Global Health Programs (GHP) account$4,725.0$4,700.0-$25.0(-0.5%)
State Department$4,395.0$4,370.0-$25.0(-0.6%)
USAID$330.0$330.0$0.0(0%)
of which Microbicides$45.0$45.0$0.0(0%)
Economic Support Fund (ESF) accountNot specifiedNot specified
Global Fund$2,000.0$2,000.0$0.0(0%)
Tuberculosisii
Global Health Programs (GHP) account$394.5$358.5-$36.0(-9%)
Economic Support Fund (ESF) accountNot specifiedNot specified
Malaria$795.0$780.0-$15.0(-2%)
Maternal & Child Health (MCH)ii
Global Health Programs (GHP) account$910.0$910.0$0.0(0%)
of which Gavi$290.0$300.0$10.0(3%)
of which Polio$85.0Not specified
United Nations Children’s Fund (UNICEF)$142.0$145.0$3.0(2%)
Economic Support Fund (ESF) accountNot specifiedNot specified
of which PolioNot specifiedNot specified
Nutritionii
Global Health Programs (GHP) account$160.0$160.0$0.0(0%)
Economic Support Fund (ESF) accountNot specifiedNot specified
Assistance for Europe, Eurasia, and Central Asia (AEECA) accountNot specifiedNot specified
Family Planning & Reproductive Health (FP/RH)iii$607.5
Bilateral FP/RHiii$575.0Not specified
Global Health Programs (GHP) accountiii$524.0$600.0$76.1(14%)
Economic Support Fund (ESF) accountiii$51.1Not specified
United Nations Population Fund (UNFPA)iv$32.5$57.5$25.0(77%)
Vulnerable Children$30.0$30.0$0.0(0%)
Neglected Tropical Diseases (NTDs)$114.5$114.5$0.0(0%)
Global Health Securityii
Global Health Programs (GHP) account$900.0$1,245.0$345.0(38%)
State Departmentv$500.0$500.0(N/A)
of which Pandemic Fund$500.0$500.0(N/A)
USAID$900.0$745.0-$155.0(-17%)
of which bilateralNot specified$435.0
of which multilateralNot specified$220.0
of which for the Coalition for Epidemic Preparedness Innovations (CEPI)$100.0Not specified
of which Emergency Reserve Fundiv$90.0
Economic Support Fund (ESF) accountNot specified$2.0
Assistance for Europe, Eurasia, and Central Asia (AEECA) accountNot specifiedNot specified
Emergency Reserve Fundvivi
Health Reserve Fundvii$8.0$10.0$2.0(25%)
Global Health Worker InitiativeNot specified$20.0
SFOPs Total (GHP account only)$10,561.0$10,928.0$367.0(3%)
Labor, Health & Human Services (LHHS)
Centers for Disease Control & Prevention (CDC) – Total Global Health$692.8$764.8$72.0(10%)
Global HIV/AIDS$128.9$128.9$0(0%)
Global Tuberculosis$11.7$11.7$0(0%)
Global Immunization$230.0$240.0$10.0(4%)
Polio$180.0$180.0$0(0%)
Other Global Vaccines/Measles$50.0$60.0$10.0(20%)
Parasitic Diseases$29.0$31.0$2.0(7%)
Global Public Health Protection$293.2$353.2$60.0(20%)
Global Disease Detection and Emergency ResponseNot specifiedNot specified
of which Global Health Security (GHS)Not specifiedNot specified
Global Public Health Capacity DevelopmentNot specifiedNot specified
National Institutes of Health (NIH) – Total Global Health
HIV/AIDSNot specifiedNot specified
MalariaNot specifiedNot specified
Fogarty International Center (FIC)$95.2$95.1-$0.03(-0.03%)
LHHS Total
Notes:
i – Unless otherwise specified, funding amounts listed under the “State, Foreign Operations, and Related Programs (SFOPs) – Global Health” heading are provided through the Global Health Programs (GHP) account.
ii – Some HIV, tuberculosis, MCH, nutrition, family planning and reproductive health, and global health security funding is provided under the ESF and AEECA accounts, which is not earmarked by Congress in the annual appropriations bills and is determined at the agency level.
iii – The FY23 Omnibus bills states that “not less than $575,000,000 should be made available for family planning/reproductive health.”
iv – The FY23 Omnibus bills state that if this funding is not provided to UNFPA it “shall be transferred to the ‘Global Health Programs’ account and shall be made available for family planning, maternal, and reproductive health activities.”
v – The FY23 Omnibus bill states that “up to $90,000,000 of the funds made available under the heading ‘Global Health Programs’ may be made available for the Emergency Reserve Fund.” The FY24 Request includes funding for the Emergency Reserve Fund under Global Health Security.
vi – The FY24 Request states that this amount is for the Pandemic Fund to “strengthen global health security and pandemic preparedness and help make the world safer from infectious disease threats.”
vii – The explanatory statement accompanying the FY23 Omnibus states that these funds are “to support cross-cutting health activities, including health service delivery, the health workforce, health information systems, access to essential medicines, health systems financing, and governance, in challenging environments and countries in crisis.” The FY24 Request states that these funds are to “support cross-cutting global health activities in challenging environments or countries emerging from crisis. It will provide flexible, no year funding to ensure basic health services are accessible to those most in need and to build more resilient health services and systems. Activities will focus on six key areas: support for health service delivery, the global health workforce, health information systems, access to essential medicines, health systems financing, and governance.”

Resources:

How Much Could COVID-19 Vaccines Cost the U.S. After Commercialization?

Published: Mar 10, 2023

Editor’s Note: This brief was updated on March 10, 2023 to reflect recent price announcements by Moderna and the release of the President’s FY 2024 budget request.

The federal government has spent more than $30 billion1  on COVID-19 vaccines, including the new bivalent boosters, incentivizing their development, guaranteeing a market, and ensuring that these vaccines would be provided free of charge to the U.S. population. However, last year, the Biden Administration announced that it no longer had funding, absent further Congressional action, to make additional purchases and it began preparing for the transition of COVID-19 vaccines to the commercial market. This means that manufacturers will be negotiating prices directly with insurers and purchasers, not just the federal government, and prices are expected to rise. Elsewhere, we have analyzed the implications of commercialization for access to and coverage of COVID-19 vaccines, finding that most, but not all, people will still have free access. Still, the cost of purchasing vaccines for the population is likely to rise on a per dose basis, though the extent to which it affects total health spending is dependent on vaccine uptake and any negotiated discounts, among other factors.

Here, we illustrate the potential total cost of Pfizer and Moderna COVID-19 vaccines, based on their publicly-announced expected prices, once they enter the U.S. commercial market. Specifically, we compare the average price paid by the federal government for the COVID-19 bivalent boosters to the estimated average commercial prices that have been suggested by manufacturers, and calculate an overall cost for purchasing vaccines for the adult population (ages 18 and older) across different scenarios of vaccine uptake (we only estimate costs for purchasing a single vaccine dose under different population uptake scenarios though it is possible that additional boosters will be needed on an annual or some other regular basis). While four COVID-19 vaccines have been authorized or approved for use in the United States, we focus our analysis only on Pfizer and Moderna vaccines, which account for almost all doses administered in the U.S. (97% as of March 22 ) and approximately 80% of all federal funding spent on COVID-19 vaccines.

The federal government has so far purchased 1.2 billion doses of Pfizer and Moderna COVID-19 vaccines combined, at a cost of $25.3 billion, or a weighted average purchase price of $20.69 per dose. In mid-2020, months before any COVID-19 vaccine was yet authorized or had even completed clinical trials, the federal government purchased an initial 200 million vaccine doses from Pfizer and Moderna (100 million each), at a price of $19.50 per dose and $15.25 per dose, respectively. This guaranteed an advance market for these vaccines, should they prove safe and effective and receive emergency use authorization (EUA) from the Food and Drug Administration (FDA), as each did in December 2020. In total, the federal government has made six different bulk purchases from Pfizer, totaling 655 million doses, and five bulk purchases from Moderna, totaling 566 million doses, for a total of 1.2 billion doses. Subsequent federal government purchases were made at a higher price per dose, with a weighted average across these purchases of $20.69. (See Figure 1 below and Tables in Appendix.)

The federal price paid per dose has generally increased over time, with the highest price paid for the most recent bivalent, or updated, boosters. The most expensive price per dose paid by the government was for the recent purchase of bivalent booster doses from each manufacturer, including 105 million doses at $30.48 per dose from Pfizer and 66 million doses at $26.36 per dose from Moderna (or a weighted average price per dose of $28.89). This represented a 56% increase in the price per dose for Pfizer, compared to the initial Pfizer purchase price, and a 73% increase for Moderna. In total, the U.S. has purchased 171 million doses of the bivalent booster at a cost of $4.9 billion.

Federal Purchases of Pfizer and Moderna COVID-19 Vaccines have Totaled $25.3 Billion at an Average Price of $20.69 per Dose

While the commercial prices for COVID-19 vaccines are not yet known, both Pfizer and Moderna have signaled likely ranges that are three to four times greater than the pre-purchased federal price for the bivalent booster. In a recent investor call, Pfizer indicated that it expected a commercial price per dose for its vaccine to be between $110 and $130. Moderna has also suggested the same range. This range is 4 to almost 5 times greater than the weighted average price per dose paid by the federal government for Moderna and Pfizer bivalent doses ($28.90).

In the unlikely outer bound scenario in which all adults were to receive a vaccine at the announced expected commercial prices, it could cost between $28.4 billion and $33.5 billion to purchase enough vaccine doses for the U.S. adult population for a one-year period (258 million doses). The lower end of this cost range ($28.4 billion for 258 million doses) is several billion higher than what the federal government has spent for more than four times as many Pfizer and Moderna doses to date ($25.3 billion for 1.2 billion doses). See Figure 2.

Potential Total COVID-19 Vaccine Cost Scenarios

Even under much lower vaccine uptake scenarios (e.g., 50% of adults getting a booster), the total cost to purchase COVID vaccines at the commercial price would still exceed the cost of purchasing enough vaccines for everyone at the federal bivalent booster price. Under a scenario where half of the adult population is vaccinated for COVID-19 at the announced commercial prices-per-dose, the total cost (ranging from $14.2 billion to $16.8 billion) still greatly exceeds the cost of purchasing vaccines for all adults at the average federal bivalent price ($7.5 billion). Although all adults are recommended to get the Omicron booster, a 50% uptake rate would be similar to that of the annual flu vaccine. If only a quarter of the adult population were to be boosted at the commercial price per dose, the total cost could range from $7.1 billion to $8.4 billion. The low end of that range is slightly lower than the cost of vaccinating all adults at the federal price. Current take-up of the Omicron booster – at 19.6% of all adults as of March 2– is even lower, though these boosters only became available last September and there are continuing efforts to encourage people to get boosted. KFF’s latest COVID-19 vaccine monitor survey found that just under a third of adults who had not yet had an updated booster said they planned to get one as soon as they could.

While most people will still be able to get COVID-19 vaccines for free, these costs will be borne by both public and private vaccine payers. As we have described in an earlier analysis, most people with health insurance will still be able to get COVID-19 vaccines, including boosters, for free even after the federally purchased supplies are depleted. But these costs will still be borne by public and private payers. In addition, the cost estimates we provide above are only for the vaccine doses themselves; there is also the cost of vaccine administration which could range from about $25 to $40 per dose, as well as a potential physician visit fee. For insured people, these costs would be covered by the insurer, as they are currently. Thus far, about four in ten adults who have received an updated booster dose are over age 65 and likely covered by Medicare, while the remaining two thirds are likely primarily covered by either Medicaid or private insurance. As older adults are more likely to opt for booster shots, a disproportionate share of the total national spending may be borne by the Medicare program. (For most preventive vaccines, Medicare pays 95% of the average wholesale price, which is often referred to as the “list” price, but we do not account for this potential modest discount in our cost illustrations above.) For private insurers and their enrollees, these costs are expected to have an upward effect on premiums. Our recent analysis of 2023 premium filings from ACA Marketplace insurers found that some insurers say the end to federal purchasing could have a small upward effect on premiums next year. These costs could continue to push premiums upward in future years as well, particularly if private insurers under-estimated the cost of the vaccine dose before Pfizer and Moderna’s price announcements.

For the uninsured and underinsured – who will not have guaranteed access to free COVID-19 vaccines – the commercial price could discourage vaccination. The suggested average price for COVID-19 vaccines after commercialization ($110 to $130 per dose) is significantly higher than the commercial price for the annual flu vaccine ($18 to 30 per dose), and could be a cost barrier for the uninsured and underinsured, who have no guaranteed mechanism for receiving COVID-19 (or any) vaccines once federal supplies are depleted. This includes people with private insurance in grandfathered or short-term limited duration health plans, as these are not subject to the Affordable Care Act’s requirement to provide recommended vaccines with no out-of-pocket cost. These individuals could have to pay all or some of the cost of the vaccine and associated physician appointments or administration fees. To provide enough COVID-19 vaccines for the 23.4 million uninsured adults in the U.S. at commercial prices for a one-year period excluding administration costs would cost between $2.6 billion and $3 billion; at the average federal price paid for the bivalent booster, it would cost $677 million. (The total cost would be higher if extended to the under-insured). To address the lack of guaranteed access to vaccines for uninsured adults, in last year’s budget request, the Biden administration proposed creating a new “Vaccines for Adults” (VFA) program to provide uninsured adults with access to all ACIP-recommended vaccines, including COVID-19 vaccines, at no cost, although Congress did not act on that proposal. The administration has once again included the proposal in its FY 2024 budget request. In addition, both Moderna and Pfizer have indicated that they will use patient assistance programs to provide free COVID-19 vaccines to the uninsured and underinsured but details on those programs are not yet available.

Discussion

On a per-dose basis, the cost to continue to vaccinate adults in the U.S. against COVID-19 after federally purchased doses are depleted is likely to be significantly higher than the costs borne in the past by the federal government. Here, we find that the commercial price ranges announced by Moderna and Pfizer are four to almost five times greater than the pre-purchased federal price for the bivalent booster, resulting in comparatively high total costs even if, for example, only half the population were to get boosted. At the same time, it is important to note that even at higher spending levels driven by commercial pricing, COVID-19 vaccination is likely to be cost-effective compared to not vaccinating, given the effectiveness of these vaccines at preventing hospitalizations and deaths.

While most consumers with public and private insurance will be protected from having to pay directly for vaccine costs, those who are uninsured and underinsured may face cost barriers when the federally-purchased vaccine doses are depleted. In addition, as private payers take on more of the cost of vaccinations and boosters, this could have a small upward effect on health insurance premiums.

Many of the factors that will influence the future commercial market and the exact price of COVID-19 vaccine doses are hard to predict at this point. Here, we illustrated the cost of a purchasing a single vaccine dose under different population uptake scenarios, but it’s possible that doses could be needed more frequently if new variants arrive, or less frequently if the pandemic wanes. Costs will also depend greatly on the number of people that elect to be vaccinated, and booster uptake is low so far. Ultimately, the price for future doses is hard to know, and they could be higher than those implied by companies so far if new formulations are developed, or could come down if discounts are negotiated. Still, insurers and public programs will not have much leverage since they are generally required to cover all ACIP recommended COVID vaccines with no patient out-of-pocket cost. Without advanced purchases or guarantees by the federal government, it’s also possible that future supply may not always match demand, which would have unpredictable consequences for the price and availability of vaccines in the U.S.

Appendix

Table 1: U.S. Government Purchases of Pfizer COVID-19 Vaccines
PurchaseDateAmount PaidNumber of DosesPrice/Dose
17/22/2020$1,950,000,000100,000,000$19.50
212/23/2020$2,011,282,500100,000,000$20.11
32/11/2021$2,011,282,500100,000,000$20.11
47/23/2021$4,869,750,000200,000,000$24.35
510/22/2021$1,230,000,00050,000,000$24.60
6*6/29/2022$3,200,000,000105,000,000$30.48
TOTAL— $15,272,315,000655,000,000$23.32

*bivalent booster

Sources: KFF analysis of data from:

Table 2: U.S. Government Purchases of Moderna COVID-19 Vaccines
PurchaseDateAmount PaidNumber of DosesPrice/Dose
18/11/2020$1,525,000,000100,000,000$15.25
212/11/2020$1,666,598,000100,000,000$16.67
32/11/2021$1,750,000,000100,000,000$17.50
46/15/2021$3,303,993,662200,000,000$16.52
5*7/29/2022$1,740,000,00066,000,000$26.36
TOTAL— $9,985,591,662566,000,000$17.64

*bivalent booster

Sources: KFF analysis of data from:

Table 3: U.S. Government Combined Purchases of Pfizer and Moderna COVID-19 Vaccines
 Amount PaidNumber of DosesWeighted Average Price/Dose
Total Combined Purchases$25,257,906,6621,221,000,000$20.69
Total Bivalent Purchases$4,940,000,000171,000,000$28.89

Source: KFF analysis

Table 4: Other U.S. Government COVID-19 Vaccine Purchases
ManufacturerDateAmount PaidNumber of DosesPrice/Dose
Sanofi/GlaxoSmithKline7/20/2020$2,042,000,000100,000,000$20.4
J&J8/5/2020$1,001,650,000100,000,000$10.0
Astra Zeneca3/21/2020$1,600,000,000300,000,000$5.3
Novavax7/7/2020$1,600,434,523100,000,000$16.0
TOTAL— $6,244,084,523 600,000,000$12.9

Sources: KFF analysis of data from:

  1. This includes vaccines that have been authorized for use in the United States (vaccines from Pfizer, Moderna, J&J, and Novavax) as well as others that either did not make it past the clinical trial phase or for which manufacturers have not sought authorization (vaccines from Merck/IAVI, Sanofi/GlaxoSmithKline and Astra-Zeneca). ↩︎
  2. Analysis of data from the CDC’s COVID-19 Data Tracker: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop5. ↩︎