Editorial Note: This brief was originally published on September 24, 2025 and was updated on October 20, 2025 to include the revised, higher cost estimate from the Congressional Budget Office of the changes to the orphan drug exclusion in the 2025 tax and budget reconciliation law.

Changes are coming to Medicare’s drug price negotiation program that could result in close to $10 billion in additional Medicare spending over time and higher out-of-pocket costs for people with Medicare. Under the Medicare Drug Price Negotiation Program, the federal government is required to negotiate with drug companies for the price of some high-spending drugs that have been on the market for several years without competition, with the goal of lowering Medicare drug spending and helping to reduce out-of-pocket costs for people with Medicare. The law that established the negotiation program, the Inflation Reduction Act of 2022, excluded certain types of drugs from negotiation, including orphan drugs approved to treat a single rare disease or condition. The new tax and budget reconciliation law passed by Congressional Republicans and signed by President Trump in July 2025 modifies the orphan drug exclusion in ways that will lead to higher Medicare spending – an additional $8.8 billion, according to a recently-updated Congressional Budget Office (CBO) estimate, up from its original estimate of $4.9 billion, which did not fully account for all the drugs that will likely be affected – and higher costs for beneficiaries who take these medications.

Takeaways

• The new tax and budget law will result in delayed eligibility or exclusion from Medicare drug price negotiation for several high-spending drugs, including a number of cancer drugs and other medications with $17.5 billion in total spending by Medicare and beneficiaries in 2023. For example, the changes in law are expected to delay selection of Keytruda and Opdivo, both on the market since 2014, by at least one year. In 2023, Medicare and beneficiaries spent $5.6 billion on Keytruda and $2.0 billion on Opdivo. Several other drugs are also likely to be delayed in their eligibility to be selected for negotiation or are now ineligible for negotiation unless they receive non-orphan approvals in the future.
• Expanding the orphan drug exclusion to allow more drugs to be delayed or excluded from Medicare drug price negotiation, as under the new tax and budget law, will mean higher out-of-pocket costs for Medicare beneficiaries who use these medications. Medicare’s negotiated drug prices can help to lower the amount beneficiaries pay, particularly in situations where they face a coinsurance requirement that is calculated based on the underlying price of the drug, such as in the case of Part B drugs and higher-cost Part D drugs. By delaying or excluding additional orphan drugs from selection for price negotiation, the tax and budget law will maintain higher prices for these drugs relative to the price Medicare would have paid if the drugs had been eligible and selected for drug price negotiation, which will translate to higher out-of-pocket liability. For example, if the government were to negotiate a 22% discount off the price of Keytruda, on par with the average 22% net price discount from the first round of Medicare drug price negotiation, that would generate annual savings on cost-sharing liability of around $3,300 for Medicare beneficiaries who use Keytruda.
• Delaying or excluding orphan drugs from Medicare drug price negotiation will cost the federal government several billion dollars over the coming decade – $8.8 billion according to CBO, or close to 10% of the overall 10-year $98.5 billion savings to Medicare that CBO projected from the Inflation Reduction Act’s Medicare drug price negotiation program when that law passed in 2022. CBO’s new estimate is 80% higher than its original estimate of $4.9 billion, which did not fully account for all the drugs that will likely be affected, including Keytruda, Opdivo, and Darzalex. The cost to Medicare of changes to the orphan drug exclusion included in the 2025 reconciliation law could also grow over time based on how the pharmaceutical industry responds, if it leads to more orphan drugs coming to market and additional orphan indications (as well as non-orphan indications) for orphan drugs already on the market to avoid or delay being subject to price negotiation.

What is the orphan drug exclusion and how does the new tax and budget law modify it?

Under the IRA, drugs that are designated for only one rare disease or condition with approvals under that one designation were excluded from Medicare drug price negotiation. This exclusion helped to address pharmaceutical industry concerns about the potential dampening effect on orphan drug research and development if drugs approved to treat a single rare disease were subject to Medicare price negotiation. After enactment of the IRA, efforts to expand the orphan drug exclusion were launched, based on pharmaceutical industry and rare disease advocacy group concerns about the potential impact on research and development for multi-orphan drugs. This echoes broader claims made by the industry about the impact on drug development associated with other policies to reduce drug prices, even as high drug prices create affordability and access challenges for patients. Nevertheless, lobbying efforts culminated with the inclusion of changes to the IRA’s orphan drug exclusion supported by the pharmaceutical industry in the recently enacted tax and budget law.

Changes in the tax and budget law include broadening the orphan drug exclusion to make orphan drugs that are designated for multiple rare diseases or conditions, not just a single rare disease, ineligible for Medicare drug price negotiation, and delaying the start of the 7- or 11-year waiting period for selection for drug price negotiation for orphan drugs that subsequently receive FDA approval for a non-orphan indication. Under the IRA, small-molecule drugs must be 7 years past FDA approval and biologics 11 years past FDA licensure when drugs are selected for negotiation. Under the new tax and budget law, for orphan drugs, this 7- or 11-year waiting period begins only when the drug has received approval for a non-orphan indication.

While these changes to Medicare’s drug price negotiation program might appear to be relatively minor, they will result in some very high-spending drugs becoming eligible for negotiation later than they otherwise would have been and other drugs will be excluded entirely unless they are approved for non-orphan uses in the future. Taken together, these changes have the potential to reduce savings to Medicare from the negotiation program and lead to higher beneficiary out-of-pocket costs.

The new tax and budget law could impact which high-spending drugs are selected for negotiation in the coming year

A number of drugs that were expected to be selected for Medicare drug price negotiation in the near future based on meeting the criteria for selection – including total Medicare spending of more than $200 million, lack of generic or biosimilar equivalents, and a sufficient number of years since FDA approval – are now likely to be off the table, either delayed in their eligibility to be selected for negotiation or no longer eligible. Among them are several high-spending cancer drugs, including Keytruda, Darzalex, Opdivo, and Jakafi, along with several other medications used to treat various types of cancer and other medical conditions (Table 1).

In 2023, spending by Medicare and beneficiaries on these drugs totaled $17.5 billion, an 83% increase since 2019 ($9.5 billion), based on Medicare Part B and Part D drug spending data from the Centers for Medicare & Medicaid Services (Figure 1, Table 2). These estimates include Part D spending under both traditional Medicare and Medicare Advantage but Part B drug spending in traditional Medicare only, since Medicare Advantage spending data are unavailable. Of these medications, Keytruda alone accounts for 32% of the total, with $5.6 billion in spending in 2023, up from $2.7 billion in 2019. Of the 734 drug and biologic products included in CMS’s Medicare Part B drug spending data for 2023, Keytruda ranked number one in terms of total spending by Medicare and beneficiaries, excluding any spending by enrollees in Medicare Advantage.

The change in law is expected to delay selection of Keytruda and Opdivo for price negotiation by at least one year, with a longer delay or exclusion from negotiation applying to other medications

Changes to the orphan drug exclusion will take effect beginning with the third round of drug price negotiation in 2026, with the selection of drugs required to be announced no later than February 1, 2026, and Medicare’s negotiated prices for these drugs taking effect on January 1, 2028. The changes are likely to have an immediate impact on which drugs are selected for Medicare price negotiation in 2026 by delaying the selection of Keytruda and Opdivo, which were likely to be selected for negotiation next year based on their total spending levels and meeting other statutory criteria.

• Keytruda, manufactured by Merck, was first approved as an orphan drug to treat melanoma in September 2014 and was subsequently approved for a non-orphan indication for non-small cell lung cancer in October 2015, followed by several other approvals for additional indications, broadening its use beyond the original rare disease approval. Under the IRA, Keytruda would have been eligible to be selected for price negotiation in February 2026, since that will be more than 11 years after its initial FDA approval, and Medicare’s negotiated price would have been available in 2028 if it had been selected next year. But under the new tax and budget law, Keytruda’s eligibility to be selected for negotiation will be delayed a year to 2027, with Medicare’s negotiated price available in 2029 if it is selected for negotiation. This is because the 13-month period that Keytruda was on the market as an orphan-only drug will not count towards the 11-year waiting period following initial FDA approval that determines when biologic drugs potentially become eligible for selection.
• A similar delay likely applies to Opdivo, manufactured by Bristol Myers Squibb, which was first approved as an orphan drug to treat melanoma in December 2014 but was subsequently approved for a non-orphan indication for non-small cell lung cancer in March 2015. Opdivo’s eligibility to be selected for negotiation will be delayed a year from 2026 to 2027, assuming the drug continues to meet other criteria for selection.

A longer delay likely applies to other orphan drugs, including Yervoy, manufactured by Bristol Myers Squibb, which was first approved as an orphan drug to treat melanoma in March 2011 but was subsequently approved for non-orphan indications for kidney cancer in April 2018 and colorectal cancer in July 2018. Eligibility for Yervoy to be selected for negotiation will likely be delayed by four years, from 2026 to 2030.

Exclusion from negotiation will now apply to several other orphan drugs based on the new tax and budget law’s changes to the IRA’s orphan drug exclusion provision. For example, Jakafi (manufactured by Incyte), Venclexta (manufactured by AbbVie), and Darzalex (manufactured by Janssen Biotech) are orphan drugs with multiple orphan designations and approvals but no non-orphan approvals, which previously made them eligible to be selected for negotiation under the IRA, but they are no longer eligible under the new tax and budget law, unless they receive approval for wider uses in the future.

The high price of these drugs has contributed to their relatively high annual Medicare spending per user

Total spending by Medicare and beneficiaries on a single claim for each of these drugs in 2023 exceeded several thousand dollars – in many cases, $10,000 or more – which translated to annual total spending per user of tens of thousands of dollars. For example, spending on the blood cancer drug Jakafi under Medicare Part D was $16,700 per claim and $138,200 per user in 2023; spending on Keytruda under Medicare Part B was $12,600 per claim and $76,100 per user in 2023, and for Opdivo, Part B spending was $10,500 per claim and $69,800 per user (Figure 2). While the total number of Medicare beneficiaries using any one of these medications is relatively low compared to more commonly used drugs – around 70,000 for Keytruda in 2023 and fewer than 30,000 for the other medications (Table 2) – their high prices translate to relatively high annual spending under Medicare.

Coinsurance requirements for high-cost Part B and Part D drugs translate to high out-of-pocket costs for Medicare beneficiaries

For high-priced drugs covered under Part B or Part D, beneficiary cost-sharing requirements in the form of coinsurance (a percentage of the drug’s total price) can translate to several hundred dollars, if not $1,000 or more, each time they fill a prescription or are administered the drug.

• Under Medicare Part B, which primarily covers physician-administered medications like Keytruda, Darzalex, and Opdivo, beneficiaries in traditional Medicare face a 20% coinsurance requirement. Most but not all traditional Medicare beneficiaries have some type of additional coverage to help with their Medicare cost-sharing requirements, such as employer-sponsored coverage, Medigap, or Medicaid. By law, beneficiary cost-sharing liability for a Part B drug or other service provided in a hospital outpatient setting on a single day cannot exceed the amount of the Part A hospital inpatient deductible, which is $1,676 in 2025. But this cap does not apply to Part B drugs administered in a physician’s office, and there is no limit on total annual out-of-pocket liability for services covered under Part A or Part B in traditional Medicare.
• Under Medicare Advantage, plans can charge no more than 20% for Part B drugs administered by an in-network provider and are required to have a maximum out-of-pocket limit, unlike traditional Medicare. In 2025, the limit averages $5,320 for in-network services and $9,547 for in-network and out-of-network services combined.
• Under Medicare Part D, coinsurance for high-priced drugs placed on the specialty tier, like Jakafi and Venclexta, ranges from 25% to 33%. Under the Part D benefit, an annual out-of-pocket spending cap of $2,000 in 2025 (increasing to $2,100 in 2026) limits an enrollee’s cost exposure, and another feature allows enrollees to spread out their out-of-pocket costs over the course of the calendar year, helping to limit the financial burden of high monthly cost-sharing requirements.

Based on these cost-sharing requirements, Medicare beneficiaries will face relatively high coinsurance for these orphan drugs each time the drug is administered or when they fill a prescription. For Part B drugs, out-of-pocket liability per claim can amount to $1,000 or more for drugs administered in a physician’s office or maxes out at the amount of the Part A inpatient deductible for drugs administered in hospital outpatient departments. For Part D drugs, beneficiaries in 2026 would likely hit the $2,100 out-of-pocket cap with a single prescription fill.

For example, based on the $12,600 total cost per claim for Keytruda in 2023, 20% coinsurance under Part B amounts to around $2,500, or roughly $15,000 for the year (based on six claims for each Keytruda user in 2023, on average). For Opdivo, coinsurance of 20% based on a $10,500 cost per claim amounts to $2,100 beneficiary liability per claim, or roughly $14,000 annually (based on 6.6 claims for each Opdivo user in 2023) (Figure 3). For Jakafi, the $16,700 total cost per claim would mean a Part D enrollee would hit the $2,100 annual out-of-pocket cap in 2026 with one fill, based on a specialty tier coinsurance requirement of 25% to 33%.

Additional delays and exclusions from Medicare drug price negotiation provided under the new tax and budget law will likely mean higher out-of-pocket costs for Medicare beneficiaries who use these medications

Medicare’s negotiated drug prices can help to lower the amount beneficiaries pay, particularly in situations where they face a coinsurance requirement that is calculated based on the underlying price of the drug, such as in the case of Part B drugs and higher-cost Part D drugs. By delaying price negotiation for certain orphan drugs or excluding them from eligibility for negotiation, the tax and budget law maintains higher prices relative to the price Medicare would have paid if the drugs had been eligible for drug price negotiation. The result will be higher out-of-pocket liability for Medicare beneficiaries, which could give rise to cost-related access problems and lower utilization.

Estimating the exact magnitude of higher cost-sharing liability would depend in part on how much lower Medicare’s negotiated prices would fall below status quo prices for drugs that would have been selected for negotiation but for the changes in law, and how much longer the higher prices apply. In the absence of these more exact estimates, the following examples of potential savings from Medicare drug price negotiation help to illustrate the potential foregone savings for beneficiaries of delaying or fully exempting orphan drugs from price negotiation.

• If the government were to negotiate a 22% discount off the price of Keytruda, on par with the average 22% net price discount from the first round of Medicare drug price negotiation, that would generate savings of around $550 per claim for Medicare beneficiaries, reducing out-of-pocket liability to just under $2,000. Annual savings would amount to around $3,300, based on an average of six claims per user in 2023.
• Similarly, for Opdivo, a 22% negotiated price discount would generate savings of around $460 per claim, reducing out-of-pocket liability to around $1,600. Annual savings would amount to around $3,000, based on an average of 6.6 claims per Opdivo user in 2023.

These illustrative examples suggest that the continuation of higher prices for certain drugs brought about by the new tax and budget law could place additional financial strain on beneficiaries in the form of higher out-of-pocket liability, with potential out-of-pocket savings from price negotiation for these high-cost drugs of several hundred dollars. At the same time, even reduced cost-sharing liability for these expensive medications might continue to represent a substantial financial burden for some Medicare beneficiaries, especially for those in traditional Medicare without additional coverage and those in Medicare Advantage prior to reaching their maximum out-of-pocket limit.

Delaying or excluding additional orphan drugs from selection for Medicare drug price negotiation will cost the federal government several billion dollars over the coming decade

According to a new estimate from the Congressional Budget Office (CBO), changes to the orphan drug exclusion in the 2025 reconciliation law will increase Medicare spending by $8.8 billion between 2025 and 2034. This is an 80% increase from CBO’s original estimate of $4.9 billion, which did not fully account for certain drugs that are likely to be affected by the changes, including Keytruda, Opdivo, and Darzalex. This higher spending erodes close to 10% of the overall 10-year $98.5 billion savings to Medicare that CBO projected from the Inflation Reduction Act’s Medicare drug price negotiation program when that law was enacted in 2022. The cost to Medicare of changes to the orphan drug exclusion included in the 2025 reconciliation law could also grow over time based on how the pharmaceutical industry responds, if it leads to more orphan drugs coming to market and additional orphan indications (as well as non-orphan indications) for orphan drugs already on the market to avoid or delay being subject to price negotiation.

With several blockbuster drugs expected to be delayed or excluded from selection for negotiation due to the changes in the new tax and budget law, CMS will be required to skip over these higher-spending drugs when it selects the list of drugs for negotiation in the future. While the changes to the IRA’s orphan drug exclusion were made in response to claims about the potential for less innovation related to drugs for rare diseases under the original provision, the changes are expected to reduce the potential savings from Medicare’s drug price negotiation program and prolong higher out-of-pocket liability for Medicare patients who use these drugs.

The recent emergence of several state health alliances marks a new phase for public health in the U.S. These alliances include two that formed last month: the “West Coast Health Alliance” announced September 3 and the “Northeast Public Health Collaborative” announced September 18, and another just this week announced by fifteen governors called the “Governors Public Health Alliance”, which has some overlapping membership with the regional alliances. To date, these alliances have included Democratic-led states only, and a common thread across all three is a broad rejection of the Trump administration’s approach to public health and the policies of the Department of Health and Human Services (HHS) under its current Secretary, Robert F. Kennedy, Jr.

Thus far this year the administration has cut staff at HHS by over 20,000 (with the Centers for Disease Control and Prevention, CDC, losing about 3,000 workers – a quarter of its staff), sought to pull back funding for state and local health departments, implemented new, more restrictive recommendations for some vaccines, and questioned long-standing scientific data and public health guidance. Many state health leaders, especially Democratic-led ones, have criticized these changes, with the new alliances being one manifestation of that push back. While the federal government is charged with issuing guidance and making recommendations that can influence public health across the country, it is states that have the ultimate authority to decide whether and where to follow that guidance.

Given this, the effects of forming these alliances generally fall into two main areas. One is practical: even if each state will continue to determine its own public health policies, alliances can foster communication and cooperation and allow for sharing of resources when needed, without necessarily relying directly on the federal government. For example, the West Coast Health Alliance aims to help align immunization recommendations across member states while the Governors Public Health Alliance seeks to be a “coordinating hub” for state leaders to share data and develop complementary public health guidance, among other activities. That could prove valuable for states that no longer have faith in the public health recommendations coming from CDC or other federal agencies. It could aid in communication with the public by providing a more unified message across states rather than each state seemingly going its own way. The other effect these alliances may have is more symbolic and political in nature: states banding together as a highly visible rebuke to the Trump administration’s public health approach and policies.

Even before these alliances were announced, many states had already started to make moves to de-link their policies from the federal government (particularly relating to vaccines). So far this year, for example, 26 states have implemented policies to ensure that pharmacists can administer COVID-19 vaccines broadly and without a prescription, despite changes – actual and anticipated – in federal recommendations coming from the Trump administration. A smaller number have moved to require state-regulated health insurers to cover, at no-cost, vaccines recommended by the state, even if they are no longer recommended by the federal government.

While it may be unusual for groups of states to join together to develop their own public health recommendations, independent of federal guidance, it’s not completely unprecedented. In the early months of the COVID-19 pandemic (during the first Trump administration) groups of Western states and northeastern states set up coalitions to coordinate responses and share supplies and know-how across state lines in the face of what they perceived as federal government inaction. Later, Republican-led states joined together in opposing some of the COVID-19 policies imposed by President Biden. 

Whether more alliances will form or these new ones will grow, remains to be seen. Ultimately, however, perhaps the most significant consequence of their formation is further cementing what is a growing partisan divide in public health, reflected in both public opinion and state policy, and which is likely to lead to increasingly divergent public health policies and access across the country and uncertainty about the future of the relationship between the federal government and the states on key public health issues.

Introduction

When used as contraception, fertility awareness-based methods (FABMs) rely on the ability to track ovulation to prevent pregnancy. FABM is an umbrella term for a variety of methods used to predict fertile and unfertile days during the menstrual cycle. Some contraceptive users may choose to use these methods because of a religious objection towards contraception involving drugs, devices, or surgical procedures, while others may prefer hormone-free methods of contraception. Oftentimes, users combine FABMs or use them in conjunction with other forms of contraception such as condoms. These methods are less effective at preventing pregnancy than other forms of reversible contraception such as the oral contraceptive pill, IUD, and implant.

In recent years, FABMs have gained attention following the increased spread of misinformation about hormonal contraception on social media, as well as Project 2025’s call for an increased focus on FABMs in the Title X program. Additionally, the Trump administration has announced that $1.5 million of Title X funding will be spent on fertility training centers aimed at addressing infertility through approaches such as FABMs. This fact sheet provides an overview of FABMs and their efficacy rates and discusses associated costs and insurance coverage of these methods.

Fertility Awareness-Based Methods

On average, each menstrual cycle has a fertile window of about six days—five days before ovulation, the day of ovulation, and up to 24 hours after ovulation—though this can vary from person to person. There are a range of tools available to help users identify their fertile days by either counting days on a calendar, observing and recording signs and symptoms associated with ovulation, or using a combination of these approaches (Table 1). FABM users who want to prevent pregnancy can remain abstinent or use a barrier method on their fertile days.

The term “FABM” is often used interchangeably with the term “natural family planning” (NFP). While this is technically correct, NFP is a subset of FABM that specifically excludes the use of drugs, surgical procedures, and barrier methods like condoms. Instead, users choose to remain abstinent on fertile days. Some religious institutions such as the Catholic Church encourage NFP for followers looking to delay or prevent pregnancy.

Calendar-based methods for tracking ovulation and fertility are some of the oldest forms of FABMs and include the Rhythm Method and the Standard Days (or Bead) Method. Users record the length of their menstrual cycles to predict their most fertile days in future cycles.

The majority of FABMs monitor and record signs and symptoms of ovulation to predict fertile days. These methods may require users to receive training from health care professionals to track daily changes to their basal body temperature (BBT), cervical mucus, or urine hormone levels. BBT measurements require a basal thermometer as it is more sensitive than a regular thermometer, and urine hormone measurements require a fertility monitor. Users often choose to track multiple indicators to prevent pregnancy more effectively.

The lactational amenorrhea method (LAM), or postpartum breastfeeding, may be used to temporarily prevent pregnancy. This method requires the postpartum parent to exclusively breastfeed their baby at least every 4 hours during the day and every 6 hours at night for up to six months (or until their menstrual cycle resumes) to delay ovulation. LAM requires strict adherence to be effective as contraception and is not suitable for postpartum parents who cannot exclusively breastfeed. It is unclear whether using breast pumps at the same frequency produces the same level of pregnancy prevention.

In addition to their use as contraception, FABMs play a crucial role in a growing movement among conservative policymakers called “Restorative Reproductive Medicine,” a practice meant to determine the root causes of infertility as well as promote fertility without the use of in vitro fertilization or artificial insemination. Similarly, “Natural Procreative Technology,” or NaPro, is another example of the role FABMs play outside of contraception. NaPro is a “fertility-care based” health care approach combining FABMs with “gynecologic health monitoring and maintenance. Though the terminology is relatively new, these practices are already included in standard gynecological and fertility care.

Use and Efficacy

In the United States, people who use FABMs to prevent pregnancy often pair them with another contraceptive method. Data from the 2024 KFF Women’s Health Survey show that 13% of women ages 18 to 49 used FABMs as contraception at some point in the last year. Individuals seeking to prevent pregnancy may choose these methods because they are hormone-free, low cost, or for religious or health reasons.

The effectiveness of FABMs in preventing pregnancy depends on the accuracy of the specific method used, the ability of the user to correctly interpret their biological signs of fertility, and the user and their partner’s ability to avoid unprotected sex during the fertile window or use a condom during that phase (Table 2). Failure rates vary across methods and range from 2 to 34 pregnancies for every 100 women per year with typical use. With perfect use, some clinical trials suggest FABMs have low failure rates. LAM, for example, is highly effective if the breastfeeding parent: 1) has amenorrhea, 2) exclusively breastfeeds at least every four hours during the day or every six hours at night, and 3) is less than six months postpartum. In comparison, less than one in 100 women using an IUD or implant, and approximately seven in 100 women using oral contraceptive pills, may become pregnant in one year of typical use.

Limitations

FABMs may prevent pregnancy for some, but there is significant room for human error that may result in unintended pregnancy, making them less effective than most other hormonal and non-hormonal contraceptive options. FABMs require significant commitment from both the user and their partner. Users are often advised to track at least six menstrual cycles to learn about their cycle length and fertility indicators before relying on an FABM to prevent pregnancy, which may leave them vulnerable to unintended pregnancy if no other contraceptive method is used during this initial period. Users must also monitor signs of fertility either daily or multiple times a day, as well as correctly interpret their observations. Finally, both the user and their partner must be able to remain abstinent or use a barrier method during the fertile window.

FABMs may not be suitable for everyone, especially for those who have irregular menstrual cycles. Calendar-based methods, for example, rely on the length of menstrual cycles regularly being between 26 and 32 days each month. Health conditions, stress, alcohol, medications, or life events affect the predictability of menstrual cycles, making FABMs less reliable. Some preliminary research suggests that clinician knowledge and perceptions of FABMs may play a role in patients’ success in using FABMs as contraception. In a survey of clinicians working in Title X clinics, providers identified several barriers to offering FABMs, including a lack of training on these methods, lack of time for counseling, low demand from patients, lower success rates, and preference for more reliable methods of contraception. Though some respondents reported providing education materials to patients upon request, they may not have had information on all FABMs. In addition, respondents perceived FABMs to be inappropriate for their patients’ needs.

Technology and Access

The correct use of FABMs requires consistency and users to have varying levels of training and technology. For calendar-based methods, users may use a physical calendar, CycleBeads, or mobile apps to track the days of their menstrual cycle. Some fertility tracking apps, such as Daysy, have tools specifically designed to sync user information to their associated app. Daysy syncs with its own BBT thermometer to digitally record the user’s temperature throughout their cycle. Other apps use algorithms to interpret user data to predict an individual’s daily risk of pregnancy. FABMs that track multiple signs of fertility sometimes require training with a licensed instructor to ensure proper use, particularly if the method has a unique system for recording these indicators such as symbols or colors.

In 2018, the Natural Cycles app became the first FDA cleared mobile medical app that can be used as contraception. The app operates by tracking the user’s daily BBT and uses an algorithm to identify fertile days and “not fertile” days. Unlike other fertility-tracking apps, Natural Cycles states that the app uses an algorithm that is personalized to the user based on their unique temperature and cycle data. In general, mobile health apps that meet the FDA’s definition of a mobile medical app or device must be approved and regulated by the FDA. While apps that do not meet this definition are exempt from FDA review, they must register with the FDA and comply with general regulations.

Over the years, health apps have come under scrutiny due to privacy concerns. In a post-Roe reproductive health landscape, users of period-tracking and fertility apps have taken to social media to caution other users about data privacy and protection, particularly for personal and identifiable information. In response, apps such as Flo have updated their privacy policies to include options such as “Anonymous Mode,” though research suggests that health apps can do more to improve user privacy.

Coverage and Cost

Federal guidelines such as the CDC’s and the Office of Population Affairs’ Providing Quality Family Planning Services (QFP) and HRSA’s recommendations for preventive services for women state that offering women the full range of FDA-approved contraceptive methods, including FABMs, is a critical element of quality family planning care. From 2022-2023, 60% of all family planning clinics and 81% of Planned Parenthood clinics offered FABM instructions or supplies.

The cost of supplies varies by method. Tools such as basal body thermometers generally cost between $10 and $20, and many fertility awareness apps in the U.S. are free to use, though some apps require subscriptions. For example, the Kindara app offers a $5 monthly subscription and a $50 annual subscription, as well as the optional Kindara Wink oral thermometer for $129. Without insurance, Natural Cycles has a $150 annual subscription that includes the Natural Cycles Thermometer, as well as a $22 monthly subscription with the option to purchase the thermometer for an additional $40. The app also syncs with the Oura Ring and certain Apple Watch models, but these devices are sold separately and not covered by insurance. 

As an FDA cleared birth control method, Natural Cycles is included in the ACA’s contraceptive coverage policy, which requires most private plans and Medicaid expansion programs to cover contraceptives for women that are prescribed by a clinician. Natural Cycles is covered by most major health insurance plans, though coverage is limited to the annual subscription with a prescription from a healthcare provider. As an over-the-counter product, coverage is not necessarily required under Medicaid. In a 2021 KFF state survey of Medicaid family planning services, few states reported covering Natural Cycles in their programs.

Some methods, such as the Creighton Model Fertilitycare System (CrMS), require classes from trained instructors. CrMS costs for the first year of use vary by instructor or program, but typically include an introductory session, an instructional kit, and at least eight follow-up sessions with an instructor, all of which can easily exceed $200. Health insurance coverage of these instructional classes varies by insurance provider and state policies.

The Role of Social Media

Contraceptive information is pervasive on social media, with nearly four in ten (39%) women of reproductive age saying they have seen or heard something on social media about birth control in the past 12 months. Some prominent social media influencers have utilized their social networks to share their negative experiences with and rationale for discontinuation of hormonal birth control methods such as oral contraceptive pills or intrauterine devices (IUDs), sometimes making false claims about the harms and efficacy of hormonal contraception. A content analysis of Pinterest in 2021 and TikTok in 2023 found that FABM-related pins conveyed more benefits than barriers, while pins about oral contraceptive pills conveyed more barriers than benefits.

Background on PEPFAR

• The President’s Emergency Plan for AIDS Relief (PEPFAR), first authorized in 2003, is the largest commitment by any nation to address a single disease, working in more than 50 countries.
• PEPFAR is credited with having saved 26 million lives and enabling 7.8 million babies to be born without HIV infection. Studies have also found that PEPFAR funding is associated with several “spillover” effects including significant reductions in all-cause mortality, increases in childhood immunizations and in GDP growth, and retention of children in school.
• PEPFAR has been reauthorized by Congress four times, most recently in March 2024 for one year. Although that authorization expired on March 25, 2025, PEPFAR is a permanent part of U.S. law and, other than a set of eight time-bound provisions, continues as long as Congress appropriates funding.
• The FY 2025 Continuing Resolution that passed in March included level funding for PEPFAR’s bilateral programming at USAID, State, CDC, and DoD of $4.85 billion (as well as level funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria and UNAIDS). The U.S. has been the top donor government to HIV efforts, through PEPFAR and contributions to the Global Fund. The administration’s FY 2026 budget request includes $2.9 billion for bilateral PEPFAR activities, a decrease of $1.9 billion (final appropriation levels are determined by Congress).
• PEPFAR is overseen by a U.S. Global AIDS Coordinator, a Senate-confirmed position appointed by the President and holding the rank of ambassador, at the State Department’s Bureau of Global Health Security and Diplomacy (GHSD). GHSD coordinates its implementation through other government agencies (primarily USAID – before its dissolution – and CDC) and with implementing partners, civil society, and recipient countries.

Current Status of PEPFAR

The following administration actions have had a significant impact on PEPFAR operations:

• Funding freeze/stop-work order: The stop-work order initially froze all PEPFAR programming and services, halting existing work in the field, including provision of antiretroviral therapy. Because it halted payments, many implementers had to let go of thousands of staff and end some services.
• Limited Waiver: PEPFAR received a limited waiver on February 1 (with additional information on February 6), allowing it to continue “life-saving HIV services”. However, the waiver only permits certain activities: HIV treatment and care, prevention of mother-to-child transmission (PMTCT), pre-exposure prophylaxis (PrEP) for pregnant and breastfeeding women, and HIV testing. Other services, including PrEP for anyone else (including those already on PrEP) and HIV prevention more generally, as well as programming for orphans and vulnerable children, are not permitted. Even with the waiver, implementers faced challenges in getting permission to resume HIV programming and difficulties getting paid.
• Dissolution of USAID: USAID was the main government implementing agency for PEPFAR, obligating 60% of its bilateral assistance in FY 2023. Without USAID and most of its staff, PEPFAR’s implementation capacity has been affected. In addition, announcements of reductions at CDC, PEPFAR’s second largest implementing agency (obligating 37% in FY 2023), could further affect PEPFAR.
• Canceled awards: In early 2025 it was reported that the administration canceled 86% of all USAID awards. KFF analysis found that of the 770 global health awards identified, 379 included HIV activities, 71% of which were terminated, including several HIV treatment awards as well as most HIV prevention.
• Legal actions: In response to two lawsuits filed against the administration’s actions, a federal judge issued a preliminary injunction ordering the government to pay for work completed by February 13, 2025, although not all payments have been made and the court has not stopped the government from canceling awards. On August 13, the U.S. Court of Appeals for the D.C. Circuit overturned the district judge’s preliminary injunction, ruling that plaintiffs lacked legal standing to challenge the administration’s termination of funding. While a District Court subsequently found that the plaintiffs could seek relief through another legal avenue and granted a preliminary injunction ordering the government to obligate expiring funds, the Supreme Court ultimately ruled that the government could withhold these funds.
• Reorganization: The administration notified Congress on March 28, 2025 of its intent to permanently dissolve USAID and that any remaining USAID operations would be absorbed by the State Department with remaining global health activities to be integrated into GHSD. On May 29, 2025, the State Department further notified Congress of its proposed reorganization plan and programs moved in July.
• Long-Acting Injectable PrEP: On September 4, 2025, the administration announced that PEPFAR would partner with the Global Fund to support provision of long-acting injectable PrEP to up to 2 million people in high-burden countries by 2028 (the announcement had initially been made by the Biden administration, and it was uncertain if it would continue).
• New Global Health Strategy: In September 2025, the administration released the America First Global Health Strategy. Per the new strategy, the U.S. will:
  • Negotiate bilateral, multi-year agreements with countries receiving PEPFAR assistance. Agreements will include co-investment by countries and aim to transition the majority of countries to full self-reliance by the end of the agreement period;
  • Provide 100% of current levels of PEPFAR funding for commodities (including antiretrovirals, diagnostics, and preventive medications) and for frontline healthcare workers through FY 2026 and reduced funding thereafter;
  • Rapidly reduce funding for PEPFAR activities other than health commodities and frontline health personnel.

Impact on PEPFAR Services and Outcomes

Numerous reports have documented the impacts of these actions on services and outcomes:

• An analysis conducted shortly after the stop-work order was issued found that 71% of PEPFAR implementing partners reported the cancellation of at least one category of activities; 50% reported staff reductions; and only 14% said they could maintain operations for one month or longer without PEPFAR funding. 
• A recent analysis found that the disruption in PEPFAR funding was associated with reduced access to HIV services and commodities, including antiretroviral treatment, PrEP, and HIV, CD4, and viral load tests.
• UNAIDS offices have identified several impacts including: the loss of thousands of HIV health workers in Kenya, Malawi, South Africa and Mozambique; disruptions to diagnostic and treatment services for pregnant women and children in Zimbabwe; partial or complete cessation of community outreach services in Angola and Eswatini; and the expected loss of a quarter of the workforce of the largest network of people living with HIV in Ukraine.
• A rapid assessment survey of 108 WHO country offices found that almost half reported moderate or severe disruptions to HIV services, including for medicines and health products, due to the U.S. foreign aid freeze and other shortages.
• In addition to these impacts, several modeling studies have estimated potential effects of funding reductions. For example, one estimated that in sub-Saharan Africa, ending PEPFAR funding could result in 565,000 new HIV infections over 10 years and reduced life expectancy of people living with HIV by 3.71 life-years.

What to Watch

• Leadership: The President has not yet nominated a Global AIDS Coordinator, and it is unclear when this might occur
• Reauthorization: It is unknown if Congress will seek to reauthorize PEPFAR, which could afford it an opportunity to propose changes to the program and extend certain time-bound provisions.
• Reorganization: The dissolution of USAID, integration of remaining USAID global health activities into GHSD, and other proposed changes at the State Department raise questions about the potential impact on PEPFAR’s operations.
• Funding/Budget Request: The administration’s FY 2026 budget request includes significant reductions in funding for global health, including a $1.9 billion reduction for PEPFAR (final appropriation amounts will be determined by Congress). The administration also submitted its first rescission package to Congress in June, including proposed rescissions of $400 million in FY 2025 funding for PEPFAR. Congress voted to amend the package, exempting PEPFAR from the rescission.
• New Global Health Strategy: Over the next few months, it is expected that the administration will develop bilateral agreements with countries regarding PEPFAR programming and plans to scale down funding, the details of which will significantly shape the future of the global HIV response.

Background on U.S. Global Tuberculosis (TB) Efforts

• The U.S. government has been involved in global TB activities for decades and began ramping up its efforts in the late 1990s when a global TB program was created at USAID.
• TB, an infectious disease caused by bacteria, causes more deaths than any other infectious agent worldwide, including 1.25 million people who died in 2023, and is among the 10 leading causes of death worldwide. TB is the leading cause of death among people with HIV.
• U.S. government efforts have contributed significantly to improving TB health outcomes, including contributing to a 29% decline in TB incidence and 47% decline in TB mortality in USAID TB priority countries since 2000.  
• The FY 2025 Continuing Resolution that passed in March included level funding for bilateral TB activities at USAID and CDC of $406 million (as well as level funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria). The U.S. has been the top donor government to TB efforts, through its bilateral funding and contributions to the Global Fund. The administration’s FY 2026 budget request includes $178 million for TB, a decrease of $228 million (final appropriation levels are determined by Congress).
• USAID had served as the lead implementing agency for U.S. TB efforts, focusing on 24 priority countries – with activities in 50 (including at least 20 of the 30 high burden countries) – to support prevention, detection, and treatment of TB, including drug-resistant TB. The Centers for Disease Control and Prevention (CDC) also carries out global TB efforts and the State Department’s Bureau of Global Health Security and Diplomacy (GHSD), which oversees PEPFAR, leads U.S. efforts to address TB-HIV co-infection.

Current Status of U.S. Global TB Efforts

The following administration actions have had a significant impact on TB program operations:

• Funding freeze/stop-work order: The stop-work order initially froze all bilateral TB programming and services, halting existing work in the field. Because it halted payments, many implementers had to let go of thousands of staff and end some services.
• Limited waiver: Some TB activities were included in a limited waiver issued by the State Department on February 4 allowing “life-saving services” to continue, which are defined as “Essential screening, testing, and treatment for tuberculosis (TB) and drug resistant TB (DR-TB) including provision and monitoring of laboratory services, drug susceptibility testing, clinical visits, dispensing of essential medicines to avert near-term mortality and spread of infection.” HIV/TB activities were also allowed under PEPFAR’s limited waiver. Even with the waivers, services remain disrupted and implementers faced challenges in getting permission to resume programming and difficulties in getting paid.
• Dissolution of USAID: As the main government implementer of TB efforts, the dissolution of USAID and loss of most staff have significantly affected TB program implementation capacity and operations. In addition, announcements of reductions at CDC could further affect global TB efforts.
• Canceled awards: In early 2025 it was reported that the administration canceled 86% of all USAID awards. KFF analysis found that of the 770 global health awards identified, 162 included TB activities, 79% of which were terminated.

• Legal actions: In response to two lawsuits filed against the administration’s actions, a federal judge issued a preliminary injunction ordering the government to pay for work completed by February 13, 2025, although not all payments have been made and the court has not stopped the government from canceling awards. On August 13, the U.S. Court of Appeals for the D.C. Circuit overturned the district judge’s preliminary injunction, ruling that plaintiffs lacked legal standing to challenge the administration’s termination of funding. While a District Court subsequently found that the plaintiffs could seek relief through another legal avenue and granted a preliminary injunction ordering the government to obligate expiring funds, the Supreme Court ultimately ruled that the government could withhold these funds.
• Reorganization: The administration notified Congress on March 28, 2025 of its intent to permanently dissolve USAID and that any remaining USAID operations would be absorbed by the State Department with remaining global health activities to be integrated into its Bureau of Global Health Security and Diplomacy (GHSD) which oversees PEPFAR. On May 29, 2025, the State Department further notified Congress of its proposed reorganization plan and programs moved in July.
• New Global Health Strategy: In September 2025, the administration released the America First Global Health Strategy. Per the new strategy, the U.S. will:
  • Negotiate bilateral, multi-year agreements with countries receiving U.S. assistance, with implementation and monitoring plans in place by March 31, 2026. Agreements will include co-investment by countries and aim to transition the majority of countries to full self-reliance by the end of the agreement period;
  • Provide 100% of current levels of funding for TB commodities [TB diagnostics (including innovations in molecular diagnostics), TB treatments (including for drug-resistant TB) and TB preventive therapy] and frontline healthcare workers through FY 2026 and reduced funding thereafter;
  • Rapidly reduce funding for activities other than health commodities and frontline health personnel.

Impact on Global TB Services and Outcomes

• An internal USAID memo reported that the cessation of USAID’s TB control programs would increase global TB incidence by 28-32% and have a similar effect on new cases of multi-drug-resistant TB.
• According to WHO, the 30 highest TB-burden countries reported that U.S. funding withdrawals were affecting services, including the loss of thousands of health workers, and disruptions of the drug supply chain and laboratory services.
• A rapid assessment survey of 108 WHO country offices found that approximately 40% reported moderate or severe disruptions to TB services, including for medicines and health products, due to the U.S. foreign aid freeze and other shortages.
• Several modeling studies have found that cuts or termination in U.S. TB funding could result in significant numbers of additional TB cases and deaths in coming years.

What to Watch

• Reorganization: The dissolution of USAID and integration of any remaining USAID global health activities, including for TB, into GHSD raises several questions, including whether additional capacities will be provided to allow for the management and implementation of TB and these other health programs at the State Department.
• Funding/Budget Request: The administration’s FY 2026 budget request includes significant reductions in funding for global health, including a $228 million reduction for TB (final appropriation amounts will be determined by Congress). The administration also submitted its first rescission package to Congress in June, including proposed rescissions of more than $1 billion in FY 2025 funding for global health. Congress voted to amend the package, reducing that amount to $500 million and exempting some program areas, including TB, from the rescission.
• New Global Health Strategy: Over the next few months, it is expected that the administration will develop bilateral agreements with countries and plans to scale down funding, including for TB-related activities, the details of which will significantly shape the future of the global TB response.

Background on U.S. Global Health Programs

• Historically, U.S. global health programs have been overseen and managed by three main federal departments and agencies: the State Department, USAID (now dissolved), and CDC.
  • The State Department is home to the Bureau of Global Health Security and Diplomacy (GHSD), which leads and oversees PEPFAR (which receives direct appropriations from Congress) as well as global health security and, more recently, other global health programs.
  • USAID, an independent agency established by Congress, had housed and managed most other U.S. bilateral global health programs, including TB, malaria, maternal and child health, and nutrition, receiving direct appropriations from Congress for these efforts. Because the State Department had not historically served as an implementing agency, USAID also managed more than half of PEPFAR’s funding, through State department transfers and direct appropriations from Congress.
  • CDC has global programs for HIV, TB, polio, and global health security, which receive direct Congressional appropriations and also manages and implements PEPFAR funding transferred by State and USAID.
• To carry out global health programs, federal agencies fund other organizations, including non-profits, foreign governments, and international and multilateral health organizations, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and Gavi, the Vaccine Alliance.
• U.S. funding for global health, across multiple federal agencies and for bilateral and multilateral programs, including global health research, totaled $12.4 billion in FY 2025.

Current Status of U.S. Global Health Programs

The following administration actions have or are likely to have a significant impact on the structure and operations of U.S global health programs:

• Funding freeze/stop-work order: The stop-work order, as part of the foreign aid review, initially froze all bilateral global health programming and services, halting existing work in the field (it was not applied to the Global Fund or Gavi). Because it halted payments, many implementers had to let go of thousands of staff and end some services.
• Limited waivers: Certain bilateral global health programs received waivers to allow “life-saving services” to continue, including a limited set of PEPFAR services and TB, malaria, maternal and child health, nutrition and infectious disease outbreak response services. Even with these waivers, services remain disrupted, and implementers faced challenges in getting permission to resume programming and difficulties in getting paid.
• Dissolution of USAID: Because USAID was the main implementing agency for global health efforts, its dissolution and loss of most of its staff have reduced program implementation capacity and operations. Announcements of reductions at CDC could further affect global health efforts.
• Cancelled awards: In early 2025 it was reported that the administration canceled 86% of USAID awards. KFF analysis found that of the 770 global health awards identified, 80% were listed as terminated, totaling $12.7 billion in unobligated funding.
• Other executive orders and actions: In addition to the foreign aid review, several other orders and actions have or will likely affect global health, including: a review of international organization participation, the reinstatement of the Mexico City Policy and withholding of UNFPA funding, and withdrawal from the World Health Organization.
• Reorganization: The administration moved to restructure and/or reduce global health efforts as follows:
  • On March 28, Secretary of State Rubio announced that the State Department and USAID had notified Congress of their intent to “restructure certain Department bureaus and offices that would implement programs and functions realigned from USAID” as follows:
    • Proposing legislation to abolish USAID as an independent agency.
    • Separating almost all USAID personnel from federal service within the current fiscal year.
    • Identifying USAID programs that “continue to advance the Administration’s foreign policy objectives,” including a subset of global health activities to be transferred to GHSD. These include programs that help reduce health disparities, deliver lifesaving vaccines, promote maternal and child health, and control malaria, TB, and other diseases.
  • On April 22, Secretary Rubio announced a reorganization of the State Department to “empower the Department from the ground up, from the bureaus to the embassies”, including removing redundant offices and non-statutory programs that are “misaligned with America’s core national interests.” On May 29, the State Department notified Congress with further details, including that GHSD would be reorganized to include three major divisions: Health Programs (with the Office of Health Programs and the Office of Program Transition and Supply Chain), Health Policy and Diplomacy (with the Office of Health Diplomacy and the Office of Program Planning and Evaluation), and Global Health Security (with the Office of Outbreak Detection and Response).
  • With the dissolution of USAID in July 2025, remaining U.S. global health programs were moved to the State Department.
• New Global Health Strategy: In September 2025, the administration released the America First Global Health Strategy, with 3 broad pillars – making America safer, stronger, and more prosperous – and focusing on HIV, TB, malaria, polio, and global health security. Per the new strategy, the U.S. will:
  • Negotiate bilateral, multi-year agreements with countries receiving U.S. assistance, with implementation and monitoring plans in place by March 31, 2026. Agreements will include co-investment by countries and aim to transition the majority of countries to full self-reliance by the end of the agreement period;
  • Provide 100% of current levels of funding for health commodities and frontline healthcare workers for HIV, TB, malaria, and polio through FY 2026 and reduced funding thereafter;
  • Rapidly reduce funding for activities other than health commodities and frontline health personnel;
  • Focus global health security activities on surveillance, data sharing and laboratory capacity, to enable early detection and rapid containment of outbreaks originating outside the U.S.

What to Watch

• Reorganization: While the reorganization of U.S. global health programs is well underway, there are still many questions about what programs will be maintained and how they will be managed, implemented and monitored, particularly given the significant reductions in federal staff as well as of health care workers more broadly who have been affected by U.S. cuts.  
• Leadership: Several leadership positions have yet to be announced, including the U.S. Global AIDS Coordinator (which requires Senate confirmation), the U.S. Malaria Coordinator, and others. Whether the administration will choose to nominate or appoint people to these positions is not yet known.

• Funding/President’s budget request: The administration’s FY 2026 budget request includes a $6.2 billion reduction in funding for global health through foreign assistance, reductions at HHS, and proposes to eliminate several funding lines (final appropriation amounts will be determined by Congress). The administration also submitted its first rescission package to Congress, including proposed rescissions of $400 million for PEPFAR and $500 million for other global health programs. Congress voted to amend the package, exempting PEPFAR funding as well as funding for maternal and child health, TB, malaria, and nutrition from the rescission, although $500 million in family planning and other programs was rescinded.
• New Global Health Strategy: Over the next few months, it is expected that the administration will develop bilateral agreements with countries regarding remaining global health programming including plans to scale down funding, the details of which will significantly shape the future of the global health response.

• Congressional oversight: As budget and reorganization proposals continue to circulate, members of Congress could choose to exert their own authority, including seeking further clarification and information about the potential impacts of proposed changes.

Background on PMI

• The U.S. government has been involved in global malaria activities since the 1950s. In 2005, the President’s Malaria Initiative (PMI) was launched to scale up efforts to address malaria in the hardest hit African countries.
• Malaria is a life-threatening disease spread to humans by mosquitoes. There are approximately 263 million malaria cases and 600,000 deaths each year; the majority of deaths are among children under age five.
• PMI is credited with helping to save 11.7 million lives and prevent 2.1 billion malaria cases since 2000. Indeed, since 2006, in countries where PMI works, global efforts have supported a 29% decrease in malaria case rates and a 48% decline in deaths. The introduction of two malaria vaccines in 2021 and 2023 has increased optimism in the potential to further strengthen global malaria control.
• U.S. malaria assistance bolsters national economies in countries and communities most heavily affected by the disease. A recent analysis found that every dollar of U.S. malaria assistance increased GDP in recipient countries nearly six-fold.
• The FY 2025 Continuing Resolution that passed in March included level funding for PMI and other malaria activities at USAID and CDC of $805 million (as well as level funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria). The U.S. has been the top donor government to malaria efforts, through PMI and contributions to the Global Fund. The administration’s FY 2026 budget request includes $424 million for malaria, a decrease of $381 million (final appropriation levels are determined by Congress).
• Overseen by a U.S. Global Malaria Coordinator, a position created by Congress in 2008 to be appointed by the President and based at USAID (now dissolved), PMI had been an interagency initiative led by USAID in partnership with CDC, focused in 30 countries that account for 90% of the world’s malaria cases and deaths.

Current Status of PMI

The following administration actions have had a significant impact on PMI operations:

• Funding freeze/stop-work order: The stop-work order initially froze all PMI programming and services, halting existing PMI activities, including bed net provision, residual spraying and delivery of antimalarial medicines. Because the order halted payments, many implementers had to let go of thousands of staff and end some services.
• Limited waiver: Malaria programs received a limited waiver on February 4 allowing “life-saving services” to continue, including those that “must resume within 30 days to ensure malaria diagnosis and treatment, as well as prevention through distribution of nets and indoor residual spraying targeting highest burden areas…and lifesaving malaria medicines for pregnant women and children”. Even with the waiver, services remain disrupted and implementers faced challenges in getting permission to resume programming and difficulties in getting paid.
• Dissolution of USAID: USAID was the main government implementing agency for malaria efforts, obligating almost all bilateral malaria assistance in FY 2023 (96%). Without USAID and most of its staff, PMI’s implementation capacity has been affected. In addition, announcements of reductions at CDC could further affect global malaria efforts.
• Canceled awards: In early 2025 it was reported that the administration canceled 86% of all USAID awards. KFF analysis found that of the 770 global health awards identified, 157 included malaria activities, 80% of which were terminated.
• Legal actions: In response to two lawsuits filed against the administration’s actions, a federal judge issued a preliminary injunction ordering the government to pay for work completed by February 13, 2025, although not all payments have been made and the court has not stopped the government from canceling awards. On August 13, the U.S. Court of Appeals for the D.C. Circuit overturned the district judge’s preliminary injunction, ruling that plaintiffs lacked legal standing to challenge the administration’s termination of funding. While a District Court subsequently found that the plaintiffs could seek relief through another legal avenue and granted a preliminary injunction ordering the government to obligate expiring funds, the Supreme Court ultimately ruled that the government could withhold these funds.
• Reorganization: The administration notified Congress on March 28, 2025 of its intent to permanently dissolve USAID and move remaining USAID operations to the State Department, with remaining global health activities to be integrated into its Bureau of Global Health Security and Diplomacy (GHSD) which oversees PEPFAR. On May 29, 2025, the State Department further notified Congress of its proposed reorganization plan and programs moved in July.
• New Global Health Strategy: In September 2025, the administration released the America First Global Health Strategy. Per the new strategy, the U.S. will:
  • Negotiate bilateral, multi-year agreements with countries receiving U.S. assistance, with implementation and monitoring plans in place by March 31, 2026. Agreements will include co-investment by countries and aim to transition the majority of countries to full self-reliance by the end of the agreement period;
  • Provide 100% of current levels of funding for malaria control commodities ([insecticide-treated bednets, malaria diagnostic tests, anti-malarial medications and malaria vaccines) and frontline healthcare workers through FY 2026 and reduced funding thereafter;
  • Rapidly reduce funding for activities other than health commodities and frontline health personnel.

Impact on PMI Services and Outcomes

• An internal USAID memo estimated that an additional 12.5-17.9 million malaria cases and an additional 71,000-166,000 deaths could occur annually if PMI was halted permanently.
• A rapid assessment survey of 108 WHO country offices found that of the 64 malaria-endemic countries surveyed, more than half reported moderate or severe disruptions to malaria services, including for medicines and health products, due to the U.S. foreign aid freeze and other shortages.
• In early April 2025, almost 30% of planned insecticide treated net (ITN) distribution campaigns were off-track or at risk of being delayed due to funding shortages, and such risks continue today. Several countries also face stock-out risks for key commodities including for rapid diagnostic tests (RDTs) and artemisinin-based combination therapy (ACT). Reductions in funding also threaten investments in new and improved malaria prevention, diagnostic, and treatment interventions.
• Such disruptions pose significant risks, particularly during peak malaria seasons across Africa where seasonal malaria campaigns are needed to protect millions of people. In a court filing challenging the funding freeze, for example, a major U.S. implementer reported that it had already had to delay the start of anti-malarial campaigns in Africa.

What to Watch

• Leadership: A U.S. Malaria Coordinator has not yet been appointed, and it is unclear, given the dissolution of USAID, what the leadership structure will be going forward.
• Reorganization: The dissolution of USAID and integration of any remaining USAID global health activities, including for malaria, into GHSD raises several questions, including whether additional capacities will be provided to allow for the management and implementation of PMI at the State Department.
• Funding/Budget Request: The administration’s FY 2026 budget request includes significant reductions in funding for global health, including a $381 million reduction for malaria (final appropriation amounts will be determined by Congress). The administration also submitted its first rescission package to Congress in June, including proposed rescissions of more than $1 billion in funding for global health. Congress reduced that amount to $500 million and exempted some program areas, including malaria, from the rescission.
• New Global Health Strategy: Over the next few months, it is expected that the administration will develop bilateral agreements with countries and plans to scale down funding, including for malaria-related activities, the details of which will significantly shape the future of the global malaria response.

Background on U.S. Global Health Security Efforts

• The U.S. has supported global health security (GHS) and pandemic preparedness efforts for decades through funding and technical support provided to low- and middle-income countries (as well as support for multilateral efforts). This has included the development of formal GHS partnerships with other countries, starting with 17 in 2014 and rising to more than 50 in 2024, with programs focused in particular in countries at risk for emerging diseases.
• GHS efforts are designed to help countries and regions build capacities needed to prevent avoidable outbreaks, detect infectious disease threats early, and reduce the impacts of epidemics and pandemics through rapid and effective responses.
• Specific activities include: improving surveillance and laboratory systems, reducing the risks of animal to human disease exposures, training epidemiologists, and fostering better biosafety and biosecurity practices.
• Multiple U.S. agencies, coordinated by the National Security Council (NSC), have been involved in these efforts including USAID (now dissolved), CDC, the Department of Defense (DoD), the State Department, HHS, and USDA. The first U.S. GHS Strategy, providing overall guidance across the government, was released by the first Trump administration. The Biden administration released an updated Strategy in 2024.
• The FY 2025 Continuing Resolution passed in March included level funding of $993 million for GHS programs at USAID and CDC. At times, Congress has provided additional, time-limited emergency funding when outbreaks occur, such as for Ebola in 2014-2015, Zika in 2016, and COVID-19 starting in 2020. The administration’s FY 2026 budget request includes $493.2 million for GHS, a decrease of $500 million (final appropriation levels are determined by Congress).
• U.S. investments in GHS have led to measurable increases in capacity, including improvement in 9 of 15 technical areas between 2018 and 2023 in GHS partnership countries and reductions in average outbreak response times.

Current Status of U.S. Global Health Security Programs

The following administration actions have had a significant impact on U.S. GHS programs:

• Funding freeze/stop-work order: The stop-work order initially froze all USAID-based GHS programming and services. As a result, many GHS implementing partners let staff go and some USAID-supported GHS activities in progress were interrupted, such as funding for transport of samples and phone plans for contact tracers.
• Limited waiver: Some GHS activities were included in a limited waiver issued by the State Department on February 4 allowing “life-saving services” to continue, including: rapid emergency response to immediate infectious disease outbreaks, focused on pathogens with pandemic potential and those that pose a national security risk to U.S. citizens (e.g., mpox and H5N1), including detection, prevention, and containment and supply of medical countermeasures. Even with the waiver, services remain disrupted and implementers faced challenges in getting permission to resume programming and difficulties in getting paid.
• Dissolution of USAID: Earlier this year, USAID had about 50 staff supporting international outbreak response efforts, a number which dropped to six in the early weeks of the Trump administration (current levels are unknown). As a result, many GHS partners have lost points of contact and technical support, in addition to the loss of funding. Announcements of reductions at the CDC could further affect GHS capacity.
• DoD GHS programs may also be targeted for cuts, with potentially up to 75% of staff to be let go.
• Reorganization: The administration notified Congress on March 28, 2025 of its intent to permanently dissolve USAID and that any remaining USAID operations would be absorbed by the State Department with remaining global health activities (including GHS work) to be integrated into its Bureau of Global Health Security and Diplomacy (GHSD). On May 29, 2025, the State Department further notified Congress of its proposed reorganization plan, and programs transitioned in July.
• GHS Strategy: The administration has withdrawn the GHS strategy, stating that it would be replaced, although no timeline has been provided. This has raised questions about coordination across the government, particularly in the event of a major threat and given the reorganization and reduction of global health programs already underway.
• New Global Health Strategy: In September 2025, the administration released the America First Global Health Strategy. It includes “making America safer” as one of its pillars, marking the first outline of its plans for GHS going forward. Per the new strategy, the U.S. will aim to:
  • Enable detection of an outbreak with epidemic potential within seven days, through strengthened surveillance, data sharing and laboratory capacity, and will assign U.S. health staff to U.S. missions;
  • Contain outbreaks originating outside the U.S. rapidly at their source, prioritizing mobilization within 72 hours of detection, support to field epidemiological staff, essential commodities, and, if needed, travel restrictions.

Impact on GHS Services and Outcomes

• The combination of administration actions described above has reduced capacity and may challenge communication and coordination across U.S. agencies and with partners, contributing to slower responses to emerging health threats, greater impacts, and increased risk of importation of diseases into the U.S.
• Experts estimate that there is a 50% chance of another pandemic emerging in the next 25 years, with the risk greatest in the least prepared countries. 
• The health impacts of poorly controlled outbreaks can be severe. An internal USAID memo reported that the risk of losing USAID GHS programs alone could result in more than 28,000 new cases of dangerous infectious diseases, such as Ebola and Marburg, every year.
• Emerging diseases can result in major economic and social costs, even with small-scale outbreaks.
  • The SARS 2003 outbreak led to an estimated $30 billion in economic losses (over $3 million per case) from reduced commerce, travel and trade.
  • The 2014-2015 West Africa Ebola epidemic led to an estimated $53 billion in economic losses. A single Ebola patient in New York cost the city’s $4.3 million in response measures.
  • Measles outbreaks in the U.S., often initiated through importation from other countries, can lead to significant costs; a recent study from Washington state found that a 71-case measles outbreak led to societal costs of $3.4 million, or almost $50,000 per case.
• Pandemics have even more massive economic costs, as experienced with COVID-19, which cost the U.S. alone an estimated at $16 trillion – a number four times the lost economic output from the 2008 financial crisis.

What to Watch

• Reorganization: The dissolution of USAID and integration of remaining USAID global health activities, including GHS, into GHSD raises questions about how activities will be integrated with existing GHSD functions and whether new capacities will be needed. GHSD has historically focused on coordination and diplomatic roles rather than the in-country implementation roles that USAID and CDC led on.
• Funding/Budget Request: The administration’s FY 2026 budget request includes significant reductions in funding for global health, including a $500 million reduction for GHS (final appropriation amounts will be determined by Congress). The administration also submitted its first rescission package to Congress, including proposed rescissions of more than $1 billion in FY 2025 funding for global health. Congress voted to amend the package, reducing that amount to $500 million and exempting some program areas from the rescission, although global health security was not listed among those program areas.
• New Global Health Strategy: Over the next few months, it is expected that the administration will develop more specific plans for its GHS work at the State Department, including with countries, which will provide more details on the future of this work.