Poll Finding

Public Views on Prescription Drug Costs: Regulation, Affordability and TrumpRx

Published: Mar 13, 2026

News Release: Poll: Public Worries About Prescription Drug Costs Reach New High; Most Across Political Parties Want Government to Do More to Regulate Prices

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Findings

Key Takeaways

  • In recent weeks, the Trump administration has renewed focus on lowering the cost of prescription drugs in the U.S., including the launch of TrumpRx. The latest polling from KFF shows that about four in 10 U.S. adults (41%) say it is likely the Trump administration’s policies will lower prescription drug costs for people like them, but views are largely influenced by partisanship. Only the president’s base remains positive, with 79% of Republicans and 88% of Make America Great Again (MAGA) supporters saying it is likely the administration will lower prescription drug costs, while much fewer independents (35%) and Democrats (11%) say it is likely. But there is broad, bipartisan agreement that the government should be playing a bigger role when it comes to regulating prescription drug costs, with at least two-thirds of Republicans, Democrats, and independents saying there is not as much government regulation as there should be in this area.
  • TrumpRx, the new federal government-run website where people can get discounts to buy prescription drugs directly from some drug manufacturers or pharmacies, has gained some attention among those who currently take prescription medication, as one-third (35%) report having heard “a lot” or “some” about it. Seven percent of adults who currently take prescription medication say they have visited the TrumpRx website to compare prescription drug prices, rising to one in six (16%) of those who currently or have ever taken a GLP-1 medication, one of the classes of drugs consumers can get discounted rates through the new website. Beyond TrumpRx, drug discounts have long been available through third-party platforms, such as GoodRx, and directly from drug manufacturers. About four in 10 report that they have used a discount coupon to reduce the cost of a drug (42%) or gone online to compare prescription drug prices to find the lowest cost option (39%).
  • The latest KFF poll shows that despite the Trump administration’s recent actions on prescription drug costs, a majority of the public (59%) is worried about affording prescription drugs for themselves and their families, the largest share since KFF first polled this question in 2018. The shares of adults worried about their prescription costs are larger among adults in households with annual incomes less than $40,000 (67%) and those who take at least four prescription medications (64%).
  • About four in 10 (43%) U.S. adults say they have not taken their medication as prescribed in the past year due to costs. This includes three in 10 who say they have taken an over-the-counter drug instead of getting a prescription filled (31%), a quarter (27%) who have not filled a prescription, and one in five (19%) who have cut pills in half or skipped doses of medicine because of the cost. Larger shares of lower-income, uninsured, Black, and Hispanic adults report taking these measures.
  • Looking ahead to the 2026 midterm elections, the Democratic Party currently holds the advantage when it comes to who voters trust to address the cost of health care, including prescription drugs. Nearly four in 10 voters say they trust the Democratic Party to do a better job addressing the cost of prescription drugs (38%), 10 percentage points larger than the share who say they trust the Republican Party more (28%). However, reflecting frustrations with lawmakers over the rising costs, about one in four (27%) voters say they trust “neither party” to handle the issue.

Most U.S. Adults Want More Regulation of Prescription Drug Pricing

There is broad, bipartisan agreement that there should be more government regulation when it comes to prescription drug costs. About seven in 10 (72%) adults say there is not enough government regulation when it comes to limiting the price of prescription drugs, while 15% say there is “about the right amount,” and 13% say there is “too much” regulation in this area. At least two-thirds of Democrats (77%), Republicans (68%), and independents (72%) say there is not enough government regulation when it comes to limiting prescription drug prices.

Among adults who currently take prescription medications, more than three in four say there is not enough government regulation of prescription drug prices (77%), including similar majorities of those who take one to three medications (78%) and four or more (75%). Among those who do not currently take prescription medications, a smaller majority agrees (62%).

Stacked bar chart showing whether adults believe there is not as much, about the right amount, or too much regulation regarding limiting the price of prescription drugs. Results shown by partisanship.

Some Adults Who Take Prescription Medication Report Visiting TrumpRx, But Most Doubt the Administration’s Policies Will Lower Costs

In early February, the Trump administration officially launched TrumpRx, the federal government-run website where people can get discounts to buy prescription drugs directly from some manufacturers or pharmacies, without using their health insurance. Few U.S. adults have heard much about the website in the weeks following its launch, and most remain skeptical that relief is coming.

One-third (35%) of adults who currently take prescription medication (66% of all adults) say they have heard “a lot” (6%) or “some” (29%) about TrumpRx, up from about one in five (18%) who had heard about plans for the site in November 2025, leaving a large majority of prescription drug users still unaware of the new program. However, awareness has grown slightly since the site’s launch as about one-third (32%) of adults who take prescription drugs now say they have heard “nothing at all” about TrumpRx, compared to six in 10 (61%) in the months preceding the launch.

With GLP-1 agonist prescriptions on the rise, KFF polling finds nearly one in five adults (18%) have ever taken a GLP-1 medication, including 12% who report currently taking one. While few prescription drug users (7%) say they have visited the TrumpRx site to shop for or compare prescription prices in the past month, this rises to about one in six (16%) among those who currently take or have ever taken a GLP-1 medication for weight loss or certain chronic conditions. The TrumpRx website features at least four major GLP-1 medications among its initial 43 listed drugs.1

Split bar chart showing shares of adults who say they have heard about TrumpRx and share who say they have visited the TrumpRx website. Results shown by adults who take prescription drugs and GLP-1 use.

The public remains skeptical that the Trump administration’s policies will lower prescription drug costs for people like them. About six in 10 (59%) adults say it is “not too likely” or “not at all likely” that the policies will lower drug costs, compared to about four in 10 (41%) who say it is “very likely” or “somewhat likely.”

These expectations largely mirror overall partisan views of actions by the Trump administration, with large majorities of Republicans (79%) and MAGA-supporting Republican and Republican leaning independents (88%) saying it is likely the administration will lower drug costs for people like them. Much smaller shares of independents (35%) and Democrats (11%) say they think the administration will lower their prescription drug costs.

Stacked bar chart showing shares of adults who say how likely t is that the Trump administration's policies will lower prescription drug costs for people like them. Results shown by adults who take prescription drugs and GLP-1 use.

Adults ages 65 and older with Medicare coverage are split on whether the administration’s policies will lower prescription drug costs for people like them (53% say it is likely, 47% say it is unlikely). Similarly, nearly half of adults who take four or more prescription medications say the administration’s policies will lower their costs (47%), while half say it is unlikely (53%). Nearly half (46%) of adults who take or have taken GLP-1 medications say the Trump administration’s policies are likely to lower their costs, while 54% say it is unlikely.

Stacked bar chart showing shares of adults who say how likely it is that the Trump administration's policies will lower prescription drug costs for people like them. Results shown by adults who take prescription drugs and insurance status, and GLP-1 use.

Prior to TrumpRx, drug discounts have long been available through third-party platforms such as GoodRx and directly from drug manufacturers. About four in 10 adults who currently take prescription medication say, in the past year, they have used a discount card or coupon to reduce their prescription drug costs, such as GoodRx, SingleCare, or a manufacturer coupon (42%), or compared prescription drug prices online to find the lowest cost option (39%). Fewer say they have purchased a lower-cost drug from an online pharmacy without their insurance (15%) or directly from a drug manufacturer’s website (8%).

Bar chart showing shares of adults who currently take prescription drugs and who say they have not taken their medication as prescribed because of the costs.

A Growing Majority of U.S. Adults Worry About Affording Their Prescription Medication Costs

Prescription drug costs are a widespread concern for U.S. adults. Two-thirds (66%) currently take prescription medication, including three in 10 (31%) who report taking four or more. Most U.S. adults are worried about affording prescription drugs for themselves and their families, and four in 10 say they have not taken their medication as prescribed in the past year due to cost.

Overall, about six in 10 U.S. adults say they are worried about being able to afford prescription drug costs for themselves or their families (59%), including about one in five (22%) who are “very worried.” Substantial shares of uninsured adults under age 65 (32%), Hispanic adults (30%), Black adults (26%), adults in households with annual incomes less than $40,000 (27%) say they are “very worried” about affording their prescription drug costs.

Among adults who take four or more prescription medications, about two-thirds (64%) report worrying about affording their medications, including about three in 10 (29%) who are “very worried.”

Stacked bar chart showing how worried shares of adults are about being able to afford prescription drugs. Results shown by race/ethnicity, household income, insurance status, and prescription drug use.

Notably, this KFF poll finds the largest share of U.S. adults saying they are “very” or “somewhat” worried about affording prescription drug costs for themselves or their families since KFF first polled on this question in 2018.

Among Medicare beneficiaries ages 65 and older, the share who report being worried about affording their prescription drug costs has remained unchanged from August 2018. The vast majority of Medicare beneficiaries are enrolled in Medicare Part D plans, giving them prescription drug coverage that has improved with recent policies in the Inflation Reduction Act of 2022.

Bar chart showing the share of adults who are very or somewhat worried about being able to afford prescription drugs from August 2018 to March 2026.

About four in 10 (43%) U.S. adults say, in the past year, they have not taken their medication as prescribed due to the cost. This includes about three in 10 adults who say they have taken an over-the-counter drug instead of getting a prescription filled because of the cost (31%), one in four who say they have not filled a prescription for a medicine due to the cost (27%), and about one in five (19%) who say they have cut pills in half or skipped doses of medicine because of the cost in the past year.

Notably, larger shares of adults report not taking medication as directed due to the cost than KFF polls found three years ago, when about three in 10 (31%) reported taking at least one of these cost-saving measures.

Larger shares of adults in households with lower and middle incomes report resorting to these cost-saving prescription medication solutions compared to those with higher incomes. About half of adults in households with annual incomes under $40,000 (52%) or between $40,000 and $90,000 (47%) say they have not taken their medication as prescribed due to the cost in the last year, compared to three in 10 adults in households with incomes of $90,000 or more.

Split bar chart showing the share of adults by income who say they have not taken their prescription drugs as prescribed because of the cost.

Democratic Party Holds the Advantage on Addressing Health Care, Prescription Drug Costs

Looking ahead to the 2026 midterm elections, the Democratic Party holds the advantage over the Republican Party on who voters trust to address health costs, including prescription drugs. Nearly four in 10 (38%) voters say they trust the Democratic Party to do a better job addressing the cost of prescription drugs, while about three in 10 (28%) say they trust the Republican Party. However, reflecting a general frustration over the cost of prescription drugs in the U.S., about one in four (27%) say they trust “neither party” to handle the issue.

The Democratic advantage on drug costs mirrors the party’s advantage on addressing health care costs overall. Four in 10 voters say they trust the Democratic Party to do a better job addressing the cost of health care, compared to about three in 10 (28%) who trust the Republican Party. Again, about one in four voters (27%) say they do not trust either party to handle the issue.

While partisans largely trust their own party to address the cost of prescription drugs and health care generally, independent voters are more likely to say they trust the Democratic Party over the Republican Party to address the cost of health care generally (34% vs. 16%) and prescription drugs (31% vs. 18%). However, more than four in 10 independent voters say they do not trust either party to do a better job handling either of these areas of affordability (44% and 41% respectively), suggesting that a substantial share of independents remain unconvinced that either party will deliver on these issues. 

Stacked bar chart showing who voters overall and independent voters trust to do a better job addressing the cost of health care and prescription drugs.
  1. Medicaid covers prescription drugs comprehensively, with enrollees paying little to nothing out of pocket. However, due to narrow exceptions, most states do not cover GLP-1 medications for weight loss. ↩︎

Methodology

This KFF Health Tracking Poll was designed and analyzed by public opinion researchers at KFF. The survey was conducted February 24 – March 2, 2026, online and by telephone among a nationally representative sample of 1,343 U.S. adults in English (n=1,268) and in Spanish (n=75). The sample includes 1,019 adults (n=62 in Spanish) reached through the SSRS Opinion Panel either online (n=995) or over the phone (n=24). The SSRS Opinion Panel is a nationally representative probability-based panel where panel members are recruited randomly in one of two ways: (a) Through invitations mailed to respondents randomly sampled from an Address-Based Sample (ABS) provided by Marketing Systems Groups (MSG) through the U.S. Postal Service’s Computerized Delivery Sequence (CDS); (b) from a dual-frame random digit dial (RDD) sample provided by MSG. For the online panel component, invitations were sent to panel members by email followed by up to three reminder emails. 

Another 324 (n=13 in Spanish) adults were reached through random digit dial telephone sample of prepaid cell phone numbers obtained through MSG. Phone numbers used for the prepaid cell phone component were randomly generated from a cell phone sampling frame with disproportionate stratification aimed at reaching Hispanic and non-Hispanic Black respondents. Stratification was based on incidence of the race/ethnicity groups within each frame. Among this prepaid cell phone component, 142 were interviewed by phone and 182 were invited to the web survey via short message service (SMS). 

Respondents in the prepaid cell phone sample who were interviewed by phone received a $15 incentive via a check received by mail or an electronic gift card incentive. Respondents in the prepaid cell phone sample reached via SMS received a $10 electronic gift card incentive. SSRS Opinion Panel respondents received a $5 electronic gift card incentive (some harder-to-reach groups received a $10 electronic gift card). In order to ensure data quality, cases were removed if they failed two or more quality checks: (1) attention check questions in the online version of the questionnaire, (2) had over 30% item non-response, or (3) had a length less than one quarter of the mean length by mode. Based on this criterion, 1 case was removed. 

The combined cell phone and panel samples were weighted to match the sample’s demographics to the national U.S. adult population using data from the Census Bureau’s 2024 Current Population Survey (CPS), September 2023 Volunteering and Civic Life Supplement data from the CPS, and the 2025 KFF Benchmarking Survey with ABS and prepaid cell phone samples. The demographic variables included in weighting for the general population sample are gender, age, education, race/ethnicity, region, civic engagement, frequency of internet use and political party identification. The weights account for differences in the probability of selection for each sample type (prepaid cell phone and panel). This includes adjustment for the sample design and geographic stratification of the cell phone sample, within household probability of selection, and the design of the panel-recruitment procedure. 

The margin of sampling error, including the design effect for the full sample, is plus or minus 3 percentage points. Numbers of respondents and margins of sampling error for key subgroups are shown in the table below. For results based on other subgroups, the margin of sampling error may be higher. Sample sizes and margins of sampling error for other subgroups are available on request. Sampling error is only one of many potential sources of error and there may be other unmeasured error in this or any other public opinion poll. KFF public opinion and survey research is a charter member of the Transparency Initiative of the American Association for Public Opinion Research.

GroupN (unweighted)M.O.S.E.
Total1,343± 3 percentage points
  
Party ID 
Democrats449± 6 percentage points
Independents449± 6 percentage points
Republicans373± 6 percentage points
  
MAGA Republicans/Republican leaning independents334± 6 percentage points
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Poll: Public Worries About Prescription Drug Costs Reach New High; Most Across Political Parties Want Government to Do More to Regulate Prices

Amid White House Push on Drug Prices, the Democratic Party Holds a 10-Percentage Point Advantage Over the GOP to Address the Issue

Published: Mar 13, 2026

As the Trump administration promotes its new TrumpRx website and other efforts to lower prescription drug prices, a growing majority of the public worries about being able to afford prescription drugs, and large majorities across parties want the government to do more to regulate prices, a new KFF Health Tracking Poll finds.

The new poll finds 59% of the public now say they are at least somewhat worried about being able to afford prescription drugs for themselves and their families, the largest share since KFF first polled on this question in 2018. This includes about one in five (22%) who are “very worried” about affording prescription drug costs.

About seven in 10 (72%) say that there is not as much government regulation as there should be when it comes to limiting drug prices, five times the share (13%) that says there is too much regulation of drug prices. In a rare moment of bipartisan agreement, at least two-thirds of Republicans (68%), independents (72%), and Democrats (77%) favor more government regulation of prices.

Fielded after the Feb. 5 launch of TrumpRx, a website that allows consumers to search for discounts on brand-name drugs, the poll finds a third (35%) of people who take prescription drugs say that they have heard at least “some” about it. Seven percent say that they have visited the website to compare prices on drugs, though the share is larger among people who take or have taken GLP-1 medications (16%), one of the categories of medications available on the site.   

Prior to the launch of TrumpRx, drug discounts have been available through third-party platforms and directly from drug manufacturers. The poll finds that about four in 10 (42%) people who take prescription drugs say that they have used such a discount card or coupon in the past year. A similar share (39%) say they compared drug prices online to find the lowest price. Fewer say they purchased a lower-cost drug from an online pharmacy without using insurance (15%) or purchased a drug directly from a manufacturer’s website (8%).

Most of the public, including most independents, are skeptical that the Trump administration will lower drug prices for people like them, but President Trump’s base is more optimistic.

Most (59%) of the public says that it is “not too likely” or “not at all likely” that the Trump administration’s policies will lower drug costs for people like them, compared to about four in 10 (41%) who say it is “very” or “somewhat” likely.

Large majorities of Republicans (79%) and supporters of President Trump’s “Make America Great Again” movement (88%) say that they expect the administration’s policies to lower drug costs. Far smaller shares of independents (35%) and Democrats (11%) say the same.

Looking ahead to November’s midterm elections, more voters say they trust the Democratic Party (38%) than the Republican Party (28%) to do a better job addressing the cost of prescription drugs, though a quarter (27%) of voters say they don’t trust either party. Democrats hold a similar trust advantage on addressing health costs in general.

Independent voters are also more likely to trust the Democratic Party than the Republican Party to address drug costs (31% vs. 18%), though a larger share trusts neither party (41%).

Designed and analyzed by public opinion researchers at KFF, this survey was conducted February 24-March 2, 2026, online and by telephone among a nationally representative sample of 1,343 U.S. adults in English and in Spanish. The margin of sampling error is plus or minus three percentage points for the full sample. For results based on other subgroups, the margin of sampling error may be higher.

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Tammie Smith

Recent Trends in Medicaid Outpatient Prescription Drugs and Spending

Published: Mar 12, 2026

In recent years, Medicaid spending on prescription drugs has grown, in part due to the emergence of new, high-cost drugs, including GLP-1s and cell and gene therapies that treat, and sometimes cure, rare diseases. There have been several recent Trump administration prescription drug initiatives (Box 1), including new payment models, that could help combat rising costs for state Medicaid programs, though questions remain about the implementation and impact of the deals. While lower prices for state Medicaid programs through the new models could result in reduced Medicaid prescription drug spending and potentially expanded coverage of certain drugs, the extent of the savings and how states or manufacturers will respond remain unclear. In most cases, Medicaid programs already pay lower prices, net of rebates, than other payers.

Medicaid enrollees are typically protected from high out-of-pocket costs for prescription drugs, meaning the recent federal prescription drug deals will not impact costs for people with Medicaid. However, the 2025 reconciliation law, signed by President Trump on July 4, 2025, is expected to result in significant Medicaid funding cuts and coverage losses. The loss of Medicaid coverage altogether could make it more difficult and costly for families to access the prescription drugs they need. While TrumpRx (see Box 1) offers discounts for uninsured or other cash-paying patients, the costs would likely still be prohibitive for low-income people with Medicaid or people who have recently lost Medicaid coverage.

This issue brief describes recent trends in the number of Medicaid outpatient prescriptions and the spending on those drugs and examines the implications of recent federal actions on future trends. Key findings include:

  • Net spending on Medicaid prescription drugs after rebates is estimated to have grown substantially in recent years, increasing from $31 billion in FY 2019 to $46 billion in FY 2024 (or 46%). Both net spending per prescription and net spending per enrollee also grew over the period, increasing by 42% (from $43 in FY 2019 to $61 in FY 2024) and 25% (from $481 in FY 2019 to $603 in FY 2024), respectively.
  • Rebates reduce Medicaid spending on prescription drugs by over half, with state supplemental rebates making up an increasing share of all rebates.
  • While net spending increased substantially, the number of prescriptions paid for by Medicaid only grew slightly in recent years, increasing from 734 million in FY 2019 to 751 million in FY 2024 (or 2%). At the same time, the number of Medicaid prescriptions per enrollee declined by 12% (from 11.2 in FY 2019 to 9.9 in FY 2024).
  • Looking ahead, more recent quarterly data show the number of Medicaid prescriptions and Medicaid enrollment declining while gross Medicaid spending remains elevated.

Box 1: Recent Federal Medicaid Prescription Drug Initiatives

“Most-favored nation” (MFN) drug pricing: Following an Executive Order in May 2025 and letters to major pharmaceutical companies in July 2025, the Trump administration announced reaching agreements with several drug manufacturers to provide MFN prescription drug pricing in Medicaid, introduce new medications at MFN prices, and sell certain products directly through TrumpRx. The manufacturers also committed to increasing their investment in U.S. manufacturing in return for a 3-year reprieve from tariffs. These MFN agreements are based on the premise that the U.S. shouldn’t pay higher prices for prescription drugs than the prices paid in other comparable nations. Details of these agreements remain confidential, leaving the full scope of the deals largely unknown. Medicaid drug prices, net of rebates, are already typically lower than for other payers in the U.S. However, there is no public information on the extent of rebates for specific drugs, so no way to compare net prices in Medicaid to those in other countries.

New CMS Innovation Center (CMMI) models: In addition to implementing the Cell and Gene Therapy (CGT) Access Model created under the Biden administration, the Trump administration has announced two new Medicaid drug pricing models. The recently announced MFN drug prices will be made available to state Medicaid programs through the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model, a drug payment model through which CMS will negotiate supplemental drug rebates based on prices paid in other countries. The model is voluntary for states and manufacturers and launched in January 2026. The Trump administration also announced the BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model, another model that intends to expand access to obesity drugs in Medicaid and Medicare by negotiating lower GLP-1 prices with manufacturers through supplemental rebates. This model is also voluntary for states and manufacturers and will launch as early as May 2026. Under both models, CMS will negotiate standardized coverage criteria in addition to supplemental rebates, and manufacturers will provide additional lifestyle supports through the BALANCE model.

President Trump’s “Great Healthcare Plan”: In his “Great Healthcare Plan,” President Trump has proposed to “codify” the administration’s MFN drug pricing deals that have been agreed to by drug companies in recent months. However, at this time very little is known publicly about the agreements, making it difficult to understand what it would mean to “codify” these deals.

TrumpRx: The administration also set up a website, TrumpRx.gov, which the public can use to search for discounted prices on brand-name medications when paying without using insurance. Through the TrumpRx website patients cannot purchase medications directly but instead, for the majority of the website’s drugs, can print drug manufacturer coupons that can be used at retail pharmacies at the time of purchase. The website launched in early February 2026, offering discounts on over 40 mostly brand name medications.

Net spending (spending after rebates) on Medicaid prescription drugs is estimated to have grown substantially in recent years, increasing from $31 billion in FY 2019 to $46 billion in FY 2024, a 46% increase (Figure 1). However, from FY 2023 to FY 2024 alone, gross spending remained relatively steady and rebates grew, resulting in net spending decreasing by 10%. Net spending per prescription grew by 42% over the period (from $43 in FY 2019 to $61 in FY 2024) (data not shown), and net spending per enrollee grew by 25% over the period (from $481 in FY 2019 to $603 in FY 2024). There are a number of factors that contribute to changes in drug spending including changes in enrollment and utilization patterns, policy changes, changes in existing drug prices, and the number and price of new drugs coming to market. Analysis has shown that recent growth in Medicaid drug spending is being increasingly driven by spending on high-cost specialty drugs, including new cell and gene therapies that treat, and sometimes cure, rare diseases and other high-cost specialty drugs like those for cancer treatment. Other drugs such as GLP-1s, which are both costly and widely utilized, also further contribute to spending increases. In addition, while there has been a substantial increase in net prescription drug spending over the period, the increase in net spending on prescription drugs is in line with increases in total Medicaid spending, which grew by 52% over the period based on KFF analysis of CMS-64 financial management reports. Overall, prescription drug spending accounted for 6% of all Medicaid spending in 2024 and has remained relatively stable between 5% and 7% of all Medicaid spending over the last two decades.

Net Spending on Medicaid Prescription Drugs Is Estimated To Have Grown Substantially in Recent Years (Stacked column chart)

Rebates reduce Medicaid spending on prescription drugs by over half, with state supplemental rebates making up an increasing share of all rebates (Figure 2). Rebates reduced gross Medicaid spending on prescription drugs by 53% on average over the period; the share of gross spending rebates accounted for declined slightly from 54% in FY 2019 to 51% in FY 2023 before increasing to 56% in FY 2024 (Figure 1). State supplemental rebates account for an increasingly larger share of all Medicaid drug rebates (Figure 2). In addition to federal statutory rebates, most states negotiate directly with manufacturers for supplemental rebates, and recent data signal states may be expanding the scope of their negotiations to combat rising drug spending. The recently announced federal models (Box 1) plan to provide lower drug prices by negotiating supplemental rebates on top of statutory rebates, though it is not clear how most-favored nation (MFN) prices under the model compared to net prices states may have already negotiated through supplemental rebate agreements. A number of factors are likely contributing to the overall uptick in rebates for FY 2024 including increasing state supplemental rebates as well as the lifting of the rebate cap beginning January 1, 2024.

State Supplemental Rebates Are Making Up an Increasing Share of All Medicaid Drug Rebates (Stacked column chart)

While net spending increased substantially, the number of prescriptions paid for by Medicaid only increased slightly from 734 million in FY 2019 to 751 million in FY 2024, a 2% increase (Figure 3). The number of Medicaid prescriptions declined in FY 2020 before steadily rising and peaking in FY 2023 and then beginning to decline again in FY 2024. The number of Medicaid prescriptions per enrollee declined by 12% over the period, falling from 11.2 in FY 2019 to 9.2 in FY 2023 before increasing to 9.9 in FY 2024. Following the initial onset of the COVID-19 pandemic, increases in Medicaid enrollment due to the continuous enrollment provision likely contributed to modest increases in prescriptions overall but declines in prescriptions per enrollee through FY 2023. Other factors, including increases in the number of days supplied per prescription, may have also played a role (this analysis does not account for days supply, see Methods). For FY 2024, Medicaid enrollment declines during the unwinding of the continuous enrollment provision as well as higher health care needs among enrollees post-unwinding are likely resulting in a decrease in the number of prescriptions but increase in prescriptions per enrollee.

The Number of Prescriptions Paid For by Medicaid Increased Slightly From FY 2019 to FY 2024 (Column Chart)

Quarterly data through most of FY 2025 show the number of Medicaid prescriptions and Medicaid enrollment continue to decline, while gross Medicaid spending remains elevated (Figure 4). Recent trends in the number of prescriptions paid for by Medicaid appear to roughly mirror trends in Medicaid enrollment, with both the quarterly number of Medicaid outpatient prescriptions and average quarterly Medicaid enrollment peaking in 2023, due to the pandemic-era continuous enrollment provision. After, during the unwinding of the provision, both enrollment and the number of prescriptions began to fall. As more provisions in the 2025 reconciliation law are implemented and individuals begin to lose coverage, Medicaid enrollment and the number of prescriptions may continue to decline. Quarterly gross spending has remained elevated despite declines in Medicaid enrollment and in the number of prescriptions. It remains unclear if recent increases in rebates will continue — blunting the increase in gross spending — or how federal changes in the 2025 reconciliation law and recent federal prescription drug initiatives (Box 1) may impact future gross and net spending trends.

Figure 4

Methods

Number of Prescriptions and Gross Spending Data: This analysis uses 2018 through 2025 State Drug Utilization Data (SDUD) (downloaded in January 2026) converted to federal fiscal years (FY). The SDUD is publicly available data provided as part of the Medicaid Drug Rebate Program (MDRP), and provides information on the number of prescriptions, Medicaid spending before rebates, and cost-sharing for rebate-eligible Medicaid outpatient drugs by national drug code (NDC), quarter, managed care or fee-for-service, and state. It also provides this data summarized for the whole country. The data do not include information on the number of days supplied in each prescription. CMS has suppressed SDUD cells with fewer than 11 prescriptions, citing the Federal Privacy Act and the HIPAA Privacy Rule. This analysis used the national totals data because less data is suppressed at the national versus state level.

Rebate Data: This analysis uses CMS-64 Financial Management Reports (FMR) for FY 2019 through FY 2024 (downloaded in August 2025). These reports include total Medicaid expenditures broken out by various service categories, and this analysis pulls out the drug rebate line items. The rebate data used includes statutory rebates, state supplemental rebates, rebates under the ACA offset, rebates from VBAs, and rebates for opioid use disorder medication assisted treatment. To estimate net Medicaid spending on prescription drugs each fiscal year in figure 1, the rebates collected in the CMS-64 were subtracted from the gross spending totals from the SDUD. State supplemental rebates in figure 2 include all “state sidebar” drug rebates in CMS-64 and rebates collected under value-based arrangements; all other rebates are categorized as federally required rebates. Supplemental rebate agreements negotiated between Medicaid managed care plans and manufacturers are not included.

Limitations: There are a number of limitations to the estimates of Medicaid prescriptions and spending found in this analysis, including:

  • This analysis examines the number of Medicaid prescriptions in the data and does not adjust for days supplied by each prescription. An increase in prescription lengths, especially during the pandemic, could contribute to fewer prescriptions.
  • The SDUD are updated quarterly; a new quarter of data is typically released, and the prior five years of data are also updated. This means prescription and gross spending totals can vary depending on when the data is downloaded, and totals may not match other outside sources or prior KFF analysis for this reason.
  • The spending collected on the CMS-64 and reported in the FMR data uses a cash-basis of accounting, meaning expenditures are based on the date of payment not necessarily when the service occurred. In practice, states have two years following the date a service was rendered to report their spending. There may be timing differences causing misalignment between the prescriptions paid for by Medicaid in the SDUD and the rebates reported in the CMS-64.
  • Drugs not dispensed by a pharmacy but received in other settings, including physician-administered drugs, can be eligible for rebates under the MDRP if they meet the definition of a “covered outpatient drug,” generally meaning a prescription drug that is FDA approved from a rebating manufacturer and identified separately on a claim for payment. This analysis includes any rebate eligible drugs, though billing practices may vary by state.
  • Spending data is not adjusted for inflation.
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Published: Mar 12, 2026

Gun violence affects many children and adolescents across the U.S. In response to growing gun violence – including school shootings – federal firearm policies and awareness of the physical and mental harm associated with gun violence have increased. However, during the second Trump Administration, some of these policies are being rolled back, including broadening access to mental health and trauma services in schools.

Over the past decade, nearly 22,000 youth ages 17 and younger died by firearm.1 For every firearm fatality, there are at least two survivors of firearm injuries. Additionally, a growing body of research links gun violence exposure – both direct and indirect – to adverse impacts on the mental health and well-being of youth. This suggests that many youths across the U.S. have experienced some form of gun violence and subsequent mental health impacts. Although the number impacted cannot be quantified due to data limitations, findings from a KFF survey provide insight on the extent of youth exposure to guns and gun violence in the U.S. For example, 20% of parents reported that they have changed or considered changing their child’s school to protect them from gun violence; and 44% of parents have a gun in the home and many of these parents have at least one gun that is not safely stored (Figure 1).

Figure 1

This brief explores the different ways in which youth gun violence occurs, disparities among youth, and how exposure is linked to negative impacts on mental health and well-being.

What is known about nonfatal firearm injury exposure among children and adolescents?

The number of nonfatal firearm injuries far exceeds the number of firearm fatalities among children and adolescents. However, estimates vary, with research suggesting nonfatal firearm injuries occur anywhere from two to four times more often than firearm fatalities. After the COVID-19 pandemic began, nonfatal firearm injuries among children and adolescents increased. The majority of youth nonfatal firearm injuries are a result of assaults.

Many children and adolescents are exposed to gun violence, even if they are not directly injured. Data on exposure to gun violence among youth is generally limited. However, a KFF analysis found that 51 per 100,000 U.S. school-age children were exposed to a school shooting from 2020-2024. Additionally, a CDC analysis found that in 34% of unintentional child and adolescent firearm deaths, at least one other child was present during the incident. Prior data from the National Survey of Children’s Exposure to Violence found that 8% of children and adolescents were exposed to a shooting in their lifetime, with a higher share (13%) reported among adolescents (ages 14-17). Further, 17% of adults in the U.S. reported witnessing someone being injured by a gun, based on a KFF poll.

Black children and adolescents are more likely to experience firearm injuries and exposures than their White peers.  Black and male children and adolescents are more likely to experience nonfatal firearm injuries than their peers – a disparity that grew alongside the pandemic. In general, children of color are more often exposed to gun violence than their White peers. Children living in areas with a high concentration of poverty are more likely to experience firearm-related deaths, and poverty disproportionately affects children of color.

How does gun violence affect the mental health and well-being of children and adolescents?

Gun violence can adversely affect the mental health and well-being of children and adolescents. Exposure to gun violence is linked to post-traumatic stress disorder and anxiety, in addition to other mental health concerns among youth. Gun violence may also lead to challenges with school performance, including increased absenteeism and difficulty concentrating. In response to indirect gun violence, such as witnessing a shooting or hearing gunshots, many children and adolescents report feeling sad, anxious, or fearful. Children and adolescents are exposed to gun violence in multiple ways, outlined below.

  • Neighborhood and community violence. Many children and adolescents experience violence within their communities. Firearm homicides occurring within an adolescent’s community have been linked to anxiety and depression among adolescents, particularly for females. Other analyses have similarly found an association between incidents of neighborhood firearm homicides and poor mental health outcomes among youth.
  • Suicide. Suicides are the second leading cause of death among adolescents and many suicides involve a firearm. Research has found that access to firearms, particularly in the home, is a risk factor for suicide deaths among children and adolescents. Nearly half of suicide attempts occur within 10 minutes of the current suicide thought, further underscoring access to firearms as a risk factor for suicide.
  • Domestic or intimate partner violence. Women and children are often the victims of intimate partner violence, which may involve firearms. The presence of a firearm in the home is linked to the escalation of intimate partner violence to homicides. Even when firearms are not used, they may serve as a means of threatening and intimidating victims of domestic violence.
  • Mass shootings. Although mass shootings, including school shootings, account for a small portion of firearm-related deaths, they can negatively impact the mental health of children and communities at large.  Youth antidepressant use and suicide risk may increase in communities with exposures to school shootings. Survey data showed that the majority of teenagers and their parents felt at least somewhat worried that a school shooting may occur at their school. School shootings are on the rise, with the U.S. average yearly rate of student exposure to a school shooting increasing threefold over time (from 19 per 100,000 students in 1999-2004 to 51 in 2020-2024, Figure 2). In response to school shootings, nearly all schools practice active shooter drills, which may have a negative psychological impact on participants. Although research is limited on how mass shootings affect individuals not directly exposed to them, current literature suggests that information and knowledge of mass shootings may be linked to increased levels of fear and anxiety.
The Rate of Students Exposed to School Shootings has Increased in Many States Over TimeYears Shown: 2020-2024U.S. Average Yearly School Shooting Exposure Rate: 51 per 100,000 Students (Choropleth map)

Youth survivors of firearm injuries are at increased risk of mental health and substance use issues, in addition to chronic physical health conditions. An analysis of commercially insured children and adolescents found that, in the year following a firearm injury, survivors were significantly more likely to experience psychiatric and substance use disorders compared to their peers. Increases in psychiatric disorders were more pronounced among youth with more severe firearm injuries compared to youth with less severe firearm injuries. Youth gunshot survivors are more likely to utilize mental health services following their injury compared to their uninjured peers. However, a study of youth survivors enrolled in Medicaid found that more than three out of five survivors had not received mental health services within the first six months following their injury.

Negative mental health impacts can extend to the family members of youth gun violence victims and to the children of parents with firearm injury. Parents, particularly mothers, of youth firearm-injury survivors had an increase in psychiatric disorders and mental health visits in the year following a firearm incident, based on an analysis of commercially insured individuals. These increases in psychiatric disorders and mental health visits were more pronounced among families of youth firearm fatalities.

  1. KFF analysis of youth firearm mortality is based on data from Center for Disease Control and Prevention (CDC) Wonder injury and mortality database. In this analysis, firearm-related deaths are defined as gun assault deaths, suicide deaths by firearm, deaths due to accidental firearm discharge, legal intervention leading to firearm death, and firearm deaths from an undetermined cause. ↩︎
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Child and Adolescent Firearm Deaths: National Trends and Variation by Demographics and States 

Author: Nirmita Panchal
Published: Mar 12, 2026

Youth gun violence sharply increased in the United States in recent years. At the same time, a growing body of research links gun violence to adverse impacts on the mental health and well-being of youth. However, understanding the full scope of the youth gun violence epidemic is limited by the lack of data on nonfatal firearm injuries. Estimates find that for every firearm fatality, there are at least two survivors of firearm injuries. Over the past decade, the number of youth who died by firearm increased by 68% (Figure 1), suggesting that many more youth have experienced nonfatal firearm injuries or some other exposure to gun violence which may impact their mental health (for example, school shootings have increased over time, as has exposure of school-aged children to these shootings).

Firearm Deaths Among Children and Adolescents Have Sharply Increased Over the Past Decade and Surpassed Motor Vehicle Deaths (Small multiple column chart)

Beginning in 2020, firearm deaths among youth (ages 17 and younger) surpassed motor vehicle deaths for the first time. Motor vehicle deaths – a longstanding leading cause of death among youth – have decreased over several decades and levelled off in recent years, largely as a result of nationwide efforts to improve safety. However, firearm deaths remain elevated in recent years and a number of safety efforts put forth in the previous Biden administration are being rolled back during the second Trump administration. This includes dismantling the White House Office of Gun Violence Prevention; building a Second Amendment Section under the Department of Justice, focused on expanding gun-rights protections; and reducing a number of funds through the Department of Justice and Bipartisan Safer Communities Act (BSCA), which were intended for improving safety and mental health resources for children. The BSCA also allocated funds to support states with Extreme Risk Protection Order policies – a red flag law linked to a reduction in suicide deaths – however, it is unclear how this funding will be impacted going forward. Separately, a KFF poll found that 44% of parents with children below 18 have a gun in their home; and large shares of these parents said a gun is stored loaded (32%), stored in an unlocked location (32%), or any gun in is stored in the same location as ammunition (61%).

This brief explores the impacts of gun violence on children and adolescents (ages 17 and below), including changes in death rates over time and by demographics, methods of gun violence exposure, and how gun violence can impact mental health and well-being. Key findings include:

  • Firearm death rates among children and adolescents increased with the onset of the pandemic, primarily driven by gun assaults. From 2021 to 2023, the firearm death rate held steady at 3.5 per 100,000 children and adolescents, before declining to 3.0 in 2024, but remaining above pre-pandemic levels.
  • Firearm deaths are more common among adolescents (ages 12-17) than younger children; Black and American Indian and Alaska Native children and adolescents than their White peers; and male children and adolescents than female.
  • States vary widely by firearm death rate, although high rates are more common in Southern states.

How have firearm deaths changed in recent years among children and adolescents?

Firearm-related death rates among children and adolescents sharply increased in 2020, alongside the onset of the pandemic; however, the latest CDC data shows a decline from 2023 to 2024 (Figure 2). From 2014 to 2024, nearly 22,000 youth ages 17 and younger died by firearm.1 During this period, firearm death rates gradually rose until 2017, held steady for a few years, and then quickly increased during the pandemic (Figure 1). While the death rate remains higher than pre-pandemic rates, there was a decrease from 2023 to 2024 (3.5 vs. 3.0 firearm-related deaths per 100,000 children and adolescents).

Firearm-Related Death Rates Among Children and Adolescents Declined in 2024 but Remain Above Pre-Pandemic Rates (Line chart)

The increase in firearm deaths in recent years was driven by gun assaults, which accounted for at least three out of five firearm deaths among children and adolescents since 2020. Gun assault deaths among children and adolescents increased over the past decade, peaking in 2022 with 1,674 deaths, before decreasing to 1,337 deaths in 2024 (Figure 3). The number of suicide deaths by firearm among children and adolescents increased overall in the past decade; and, in 2024, accounted for 31% of firearm deaths.

Gun Assaults Accounted For At Least Three Out of Five Firearm Deaths Among Children and Adolescents Since 2020 (Stacked column chart)

By 2024, 68% of total assault deaths among children and adolescents involved a firearm; and 45% of total suicide deaths involved a firearm (Figure 4). From 2014 to 2024, the share of total assault deaths involving a firearm increased from 49% (703 out of 1,439 deaths among children ages 17 and younger) to 68% (1,337 out of 1,959 deaths). During the same period, the share of total suicide deaths involving a firearm also increased but to a lesser extent compared to firearm assaults. In 2024, 45% of suicide deaths involved a firearm (687 out of 1,530 deaths among children ages 17 and younger) compared to 40% in 2014 (532 out of 1,344 deaths).  

The Majority of Assault Deaths and Nearly Half of Suicide Deaths Among Children and Adolescents Involved a Firearm in 2024 (Stacked Bars)

How do youth firearm deaths vary by demographic characteristics?

In 2024, firearm death rates were highest among adolescents (ages 12-17), Black and American Indian and Alaska Native (AIAN) youth, and male youth (Figure 5). The adolescent (ages 12-17) firearm death rate was 7.5 per 100,000 compared to 0.6 for children ages 11 and below. Black and AIAN youth experienced a significantly higher firearm death rate (10.0 and 6.8 per 100,000) compared to their White peers (1.9). Males ages 17 and below were five times more likely than their female peers to die by firearm (5.0 per 100,000 vs. 1.0 in 2024).

Firearm Death Rates Are Highest Among Adolescents (Ages 12-17), Black and AIAN Youth, and Male Youth (Bar Chart)

In 2024, Black youth accounted for 46% of all youth firearm deaths although they made up only 14% of the U.S. youth population (Figure 6).  In contrast, White youth accounted for 29% of all youth firearm deaths and they made up nearly half (48%) of the youth population in 2024. 

Black Youth Accounted for 46% of All Youth Firearm Deaths Although They Made Up Only 14% of the U.S. Youth Population (Stacked Bars)

How do youth firearm deaths vary across states?

Firearm death rates among children and adolescents range from a high of 10.1 per 100,000 in the District of Columbia to a low of 0.7 in Massachusetts; however, many states with high rates are concentrated in the south (Figure 9). From 2020 to 2024 the states with the highest firearm death rates among children and adolescents were the District of Columbia, Mississippi, and Louisiana (10.1, 8.7, and 8.4 per 100,000 respectively for combined years, 2020-2024). Almost all states experienced an increase in firearm death rates over the decade, with the largest increases seen in North Carolina and Mississippi (109% and 107% respectively) (see Appendix). The states with the lowest firearm death rates were Massachusetts, New Jersey, and New York (0.7, 0.9, and 1.1 per 100,000 respectively for combined years, 2020-2024). States also vary widely in their provisions on gun safety, including child access prevention laws and Extreme Risk Protection Order (ERPO) policies. 

States Vary by Youth Firearm Death Rate, Although High Rates are More Common in Southern States (Choropleth map)

Appendix

State-by-State Shifts in Firearm Death Rates Among Children and Adolescents Over Time (Table)
  1. KFF analysis of youth firearm mortality is based on data from Center for Disease Control and Prevention (CDC) Wonder injury and mortality database. In this analysis, firearm-related deaths are defined as gun assault deaths, suicide deaths by firearm, deaths due to accidental firearm discharge, legal intervention leading to firearm death, and firearm deaths from an undetermined cause. ↩︎
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Status of State Medicaid Expansion Decisions

Published: Mar 12, 2026

The Affordable Care Act’s (ACA) Medicaid expansion expanded Medicaid coverage to nearly all adults with incomes up to 138% of the Federal Poverty Level ($21,597 for an individual in 2025) and provided states with an enhanced federal matching rate (FMAP) for their expansion populations.

To date, 41 states (including DC)   have adopted   the Medicaid expansion and 10 states   have not adopted   the expansion. Current status for each state is based on KFF tracking and analysis of state expansion activity.

These data are also available in a table format. The map may be downloaded as a Powerpoint.

Status of State Action on the Medicaid Expansion Decision (Choropleth map)
Key States with Expansion Activity (Table)

Medicaid Expansion Resources

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VOLUME 42

Officials Amplify Fluoride Concerns as Federal Review and State Restrictions Advance

Plus, Tracking AI and Content Moderation Developments

Joel Luther , Hagere Yilma , and Irving Washington

Highlights

The Environmental Protection Agency (EPA) has launched the next step in its accelerated review of fluoride safety as more states move to ban community water fluoridation. The review arrives as senior officials have amplified concerns about fluoride that go beyond what the current evidence supports.

The Monitor also explores several developments related to AI policy and content moderation, including the growing adoption of a practice called “generative engine optimization” (GEO) to influence what AI chatbots say. A new study suggests that the same techniques used to make accurate information more visible to AI may also make these tools more susceptible to false health claims.

What We’re Watching

Fluoride Safety Review Advances as States Move to Ban Water Fluoridation

The Environmental Protection Agency (EPA) has released a preliminary assessment plan and literature survey as the first phase in its expedited review of fluoride safety, acting on concerns largely based on misleading claims about harms. The review advances a priority of some in the Make America Healthy Again (MAHA) movement and accelerates a report not otherwise due until 2030. Water fluoridation reduces tooth decay by more than 25% in children and adults, and the scientific basis for concern is limited. A 2024 National Toxicology Program report suggested an association between fluoride and lower IQ in children, but the report analyzed studies conducted outside the U.S. at fluoride levels more than twice the American standard. Nevertheless, senior officials including HHS Secretary Robert F. Kennedy Jr. have amplified concerns about fluoride without adequate scientific support, and policy actions have followed. Florida and Utah have already banned community water fluoridation, with similar bills introduced in at least 19 other states. The FDA has also moved to restrict some fluoride supplements, the alternative that opponents to fluoridation have promoted, and dental professionals report growing reluctance among parents and providers to use them.

What To Watch Out For: The EPA review is still ongoing, but regardless of its findings, the process itself risks undermining public confidence in a longstanding and effective public health intervention. As the alternatives that opponents to community water fluoridation have promoted also face regulatory challenges, confusion may persist among the public about fluoride’s safety. KFF Health News reporting has shown an increase in emergency room visits for preventable tooth problems in recent years, a trend that could worsen as these narratives and policies continue to spread.

The National Cancer Institute has begun a preclinical study of ivermectin to examine its potential effects on cancer cells, a decision that follows sustained public claims that the drug can treat cancer and recent state efforts to expand over-the-counter access. Ivermectin is approved by the FDA for certain parasitic infections but not for cancer, and it has not been shown to be safe or effective for this use in humans. Some scientists within the agency have questioned whether funding this research may limit support for other cancer studies. The study is taking place as legal debates continue over state disciplinary actions against physicians who promoted ivermectin for COVID-19, with some advocates seeking review by the Supreme Court on free speech grounds.

What To Watch Out For: These developments show how public claims about a drug can intersect with research priorities, state access laws, and legal challenges. Patients who encounter these claims may find it difficult to distinguish between legitimate scientific inquiry and the amplification of unproven uses for treatments like ivermectin.

Seasonal Vaccine Hesitancy Persists Among Older Adults, Survey Finds

About three in ten (29%) adults age 50 and older reported receiving both flu and COVID-19 vaccines in the past six months, according to a new survey of adults older than 50 fielded between December 2025 and January 2026. The most common reason respondents gave for skipping vaccination was that they didn’t think they needed it, despite evidence that both viruses pose elevated risk of serious illness and death in older populations. Concerns about side effects and doubts about effectiveness were also common, particularly for COVID-19. Vaccination rates were highest among adults 75 and older, the group at greatest risk for serious illness or death, but even among that group there was a gap between flu and COVID-19 vaccine uptake, with about three quarters (76%) reporting being vaccinated for the flu in the previous six months, compared to just under half (46%) for COVID-19.

What To Watch Out For: The survey findings arrive after federal health agencies narrowed the approval for COVID-19 vaccines, limiting eligibility to those who are 65 or older or have underlying health conditions. Ongoing changes to federal vaccine guidance may reinforce the perception that seasonal vaccines are unnecessary, even among those who remain eligible.

Polling Insights: KFF’s January 2026 Tracking Poll on Health Information and Trust found that while most adults (69%) express confidence in the safety of flu vaccines for adults, COVID-19 vaccines are much more divisive, with just over half (55%) of adults expressing confidence in their safety. Lower confidence in the safety of COVID-19 vaccines for adults is driven in large part by partisanship, with fewer than half (32%) of Republicans expressing confidence compared to larger shares of independents (53%) and Democrats (82%). Majorities across partisanship say they are confident in the safety of flu vaccines for adults, though Democrats and independents are more likely than Republicans to express confidence.

Split bar chart showing percent who say they are very or somewhat confident that specific vaccines are safe for children. Results shown by total adults, total parents, party identification, and support for the Make America Healthy Again movement.

What Else We’re Watching

Generative Engine Optimization Seeks to Shape What AI Says

As people turn to AI tools like ChatGPT and Claude for health information, some publishers and organizations are deliberately structuring and writing content so that AI systems are more likely to surface it in responses. Recent reporting by The New York Times showed that health care and pharmaceutical companies were among the earliest adopters of this practice, termed “generative engine optimization” (GEO). While this practice can help accurate information reach users, it also raises questions about whether the same techniques could be used to spread false health claims.

Generative engine optimization (GEO) is the practice of structuring digital content so that AI tools such as ChatGPT or Claude are more likely to surface it in their responses.

What To Watch Out For: Will health care organizations and publishers continue adopting GEO to influence AI chatbot responses? Will bad actors exploit the same techniques to spread false health claims through AI tools?

AI More Likely to Accept False Health Claims in Clinical Language, Study Finds

A study published in The Lancet Digital Health found that AI models accepted false medical recommendations in discharge notes five times more often than those in Reddit posts, at 47% compared to just 9%. The study tested 20 AI models, including OpenAI’s ChatGPT, Meta’s Llama, and Google’s Gemma, by exposing them to false medical claims written in different styles: hospital discharge notes with a single false recommendation inserted by physicians, health myths pulled from Reddit, and simulated clinical scenarios written by doctors. False information accepted by the models included advice like “drink a glass of cold milk daily to soothe esophagitis-related bleeding.” Researchers concluded that the formal, authoritative language found in actual discharge notes made the models more likely to accept false information. For users seeking health information from AI tools, these findings point to an unexpected risk. While some may assume that AI will catch errors in formal documents, the findings show that these models may apply less scrutiny to clinical language, making errors in discharge notes or clinical summaries less likely to be caught. The authors call for context-aware safeguards, particularly in systems that generate discharge recommendations or after-visit summaries.

What To Watch Out For: Will health systems and AI developers build safeguards that account for AI’s greater susceptibility to formal clinical language? How will patients and providers know when to trust AI-generated health guidance?

FTC Signals Limited Focus on AI Enforcement

In December 2025, President Trump issued an executive order directing federal agencies, including the Federal Trade Commission (FTC), to identify state laws that might require AI models to produce what the administration contends are misleading outputs and assess whether federal law can override them. The administration frames these laws as potential sources of misinformation or “deception” in AI, linking them to concerns about ideological bias against conservative opinions. A bipartisan group of 36 state attorneys general, though, has argued that many of the laws in question are consumer protection measures, like those targeting deceptive deepfakes or AI-generated scams. The FTC is tasked with issuing a policy statement on whether its authority under the Federal Trade Commission Act could preempt such state rules. In practice, the FTC’s legal authority to preempt state laws is limited and would require a lengthy rulemaking process, making broad federal preemption unlikely in the near term, though the agency continues to pursue false advertising and deceptive practices. Legal analysts have interpreted this as signaling a narrow, targeted approach that aligns with the Trump administration’s deregulatory focus on AI innovation and investment.

What To Watch Out For: Will the FTC’s policy statement signal a broader effort to limit state-level restrictions on AI? How will the agency balance protecting consumers from deceptive practices with the administration’s deregulatory priorities?

X Tests AI-Assisted Crowdsourced Fact-Checking

A new feature on the social media platform X uses generative AI to propose Community Notes fact-checks, which human contributors then review and edit. Previously, X relied on a fully crowdsourced model, before introducing autonomous AI-written notes in July 2025. The latest change adds a human review step to that process. A recent investigation found that AI-generated notes, which must meet the same cross-ideological agreement threshold as human-written notes to be published, account for about 17% of Community Notes, with peaks as high as 27%. X officials have said that the collaboration between human editors and AI produces faster and more accurate notes. At the same time, some research has suggested the relationship between AI fact-checking tools and crowdsourced moderation may be more complicated. One working paper, for example, found that user participation in the Community Notes program declined following the introduction of X’s AI chatbot Grok, with researchers suggesting AI may be acting as a substitute for crowdsourced fact-checking rather than a complement to it. Whether AI-assisted content moderation improves the reliability of fact-checking on the platform may have implications beyond X, as both Meta and TikTok have adopted similar crowdsourced approaches.

What To Watch Out For: Will AI-assisted Community Notes prove more or less accurate than those written solely by humans or entirely by AI? Will human involvement in the program continue to decline?

More From KFF

About The Health Information and Trust Initiative: the Health Information and Trust Initiative is a KFF program aimed at tracking health misinformation in the U.S., analyzing its impact on the American people, and mobilizing media to address the problem. Our goal is to be of service to everyone working on health misinformation, strengthen efforts to counter misinformation, and build trust. 

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The Monitor is a report from KFF’s Health Information and Trust initiative that focuses on recent developments in health information. It’s free and published twice a month.

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Support for the Health Information and Trust initiative is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed do not necessarily reflect the views of RWJF and KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities. The data shared in the Monitor is sourced through media monitoring research conducted by KFF.

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Key Facts About Medicare Drug Price Negotiation

Published: Mar 11, 2026

Editorial Note: This brief was updated in March 2026 to reflect the results of the second round of Medicare drug price negotiation and details about the third cycle of the negotiation program, including the list of drugs selected for negotiation in early 2026.

Under the Medicare Drug Price Negotiation Program, the Secretary of Health and Human Services (HHS) is required to negotiate prices with drug companies for certain high-cost drugs covered under Medicare. This requirement, a provision of the Inflation Reduction Act of 2022 (IRA), was the culmination of years of debate among lawmakers over whether to grant the federal government the authority to negotiate drug prices in Medicare.

Medicare’s drug price negotiation program is now in its third cycle, with CMS having concluded two rounds of drug price negotiation to date. Negotiated prices for the first set of 10 Medicare Part D drugs selected for negotiation went into effect on January 1, 2026, while negotiated prices for the second set of 15 Part D selected drugs (including the popular GLP-1 diabetes and obesity drugs Ozempic and Wegovy) will take effect in 2027. In January 2026, CMS announced an additional 15 Part D and Part B drugs selected for negotiation, with negotiated prices effective in 2028. Total Medicare spending on the 40 drug products that have been selected for negotiation to date accounted for more than one-third (36%) of total Medicare spending on all drugs covered under Part B and Part D in 2024, or $125 billion out of $350 billion (not accounting for rebates in Part D and excluding spending on Part B drugs under Medicare Advantage since data are unavailable). The Centers for Medicare & Medicaid Services (CMS) has estimated several billion dollars in net savings to Medicare for round one and round two Part D drugs based on Medicare’s negotiated prices relative to existing net prices paid by Part D plans.

This brief provides information about several key aspects of the Medicare drug price negotiation program, with a focus on the 2028 implementation year, drawing on guidance from the Centers for Medicare & Medicaid Services (CMS). This is the first year CMS is required to negotiate physician-administered drugs covered under Medicare Part B. It is also the first year that a change to the IRA’s orphan drug exclusion is in effect, based on a provision in the 2025 reconciliation law that broadened this exclusion and exempted more drugs from negotiation.

Table of Contents

In 2026, CMS selected 15 Medicare Part B and D drugs for price negotiation, with negotiated prices taking effect in 2028

Copy link to In 2026, CMS selected 15 Medicare Part B and D drugs for price negotiation, with negotiated prices taking effect in 2028

Fifteen drugs covered under Medicare Part B, which covers physician-administered drugs, or Medicare Part D, Medicare’s outpatient prescription drug benefit program, were selected for price negotiation in 2026, with Medicare’s negotiated prices for these drugs taking effect on January 1, 2028 (Table 1). These 15 drugs include treatments for type 2 diabetes, HIV, asthma, arthritis, psoriasis, Crohn’s disease, several types of cancer, and other conditions (See Table 1). Total gross Medicare spending on these 15 drugs between November 2024 and October 2025 was $27 billion, with 1.8 million Medicare beneficiaries using these medications during that time. Starting in 2027 and in each subsequent year, up to 20 additional drugs covered under Part B or Part D will be selected for negotiation. The number of drugs with negotiated prices available will accumulate over time.

Drugs Selected for Medicare Drug Price Negotiation for 2028 (Table)

CMS has concluded two rounds of drug price negotiation to date, with estimated savings of several billion dollars based on Medicare’s negotiated prices relative to existing net prices

Copy link to CMS has concluded two rounds of drug price negotiation to date, with estimated savings of several billion dollars based on Medicare’s negotiated prices relative to existing net prices

Based on the negotiated prices for first 10 Part D drugs selected for negotiation, CMS estimated that Medicare would have saved $6 billion if the prices that CMS negotiated had been in effect in 2023, amounting to net savings of 22% on these drugs. CMS also estimated that Medicare beneficiaries will save $1.5 billion when these negotiated prices take effect in 2026. Based on negotiated prices for the next 15 Part D drugs selected for negotiation, CMS estimated even greater savings of $12 billion relative to existing net prices in 2024, amounting to net savings of 44% on these medications – higher due in part to the larger number of drugs subject to negotiation. CMS has also estimated that Medicare beneficiaries will save $685 million when these negotiated prices take effect in 2027.

Selected Drugs for Implementation Year 2026: The first 10 Medicare Part D drugs that were selected for negotiation include treatments for several medical conditions, including diabetes (Farxiga, Fiasp/NovoLog, Januvia, Jardiance), blood clots (Eliquis, Xarelto), heart failure (Entresto, Farxiga), psoriasis (Stelara, Enbrel), rheumatoid arthritis (Enbrel), Crohn’s disease (Stelara), and blood cancers (Imbruvica) (Table 2). Medicare’s negotiated prices took effect on January 1, 2026. CMS published explanations of its negotiated prices and the factors that were considered in the negotiation process, including manufacturer-specific financial data about the selected drugs and evidence about the clinical benefits of selected drugs compared to alternative treatments.

Drugs Selected for Medicare Drug Price Negotiation for 2026 (Table)

Selected Drugs for Implementation Year 2027: The 15 Medicare Part D drugs selected for price negotiation in round two included the popular GLP-1 diabetes and obesity drugs Ozempic and Wegovy, along with other drugs used to treat asthma and chronic obstructive pulmonary disease, type 2 diabetes, prostate and breast cancer, and other conditions (Table 3). Negotiated prices for these drugs will take effect on January 1, 2027.

Drugs Selected for Medicare Drug Price Negotiation for 2027 (Table)

Drugs qualify for price negotiations if they have high total Medicare spending, no generic or biosimilar equivalents, and are several years past FDA approval

Copy link to Drugs qualify for price negotiations if they have high total Medicare spending, no generic or biosimilar equivalents, and are several years past FDA approval

Drugs qualify for price negotiation if they are single source brand-name drugs or biological products without therapeutically-equivalent generic or biosimilar alternatives that are approved or licensed and marketed on a “bona fide” basis – a determination to be made by CMS using FDA reference sources to determine whether a generic or biosimilar has been approved, along with claims and pricing data to assess utilization and sales of generics or biosimilars and other public information related to product launch and distribution. In addition, a drug product must be at least 7 years (for small-molecule drugs) or 11 years (for biologics) past its FDA approval or licensure date, as of the date that the list of drugs selected for negotiation is published, giving manufacturers several years to market their products before being eligible for negotiation. This means that for a single source drug to be eligible for negotiation for 2028, a drug product must have been approved on or before February 1, 2019, and a biological product must have been licensed on or before February 1, 2015. For drugs with multiple FDA approvals, CMS uses the earliest approval date to determine the number of years that have elapsed.

The definition of ‘qualifying single source drug’ excludes certain types of drugs:

  • Orphan-drugs – drugs that are designated for rare diseases or conditions and approved only for those diseases or conditions (known as the orphan drug exclusion, which was modified by the 2025 reconciliation law, as described below),
  • Low-spending drugs – drugs with combined total spending under Part B and Part D of less than an inflation-adjusted threshold amount (originally set at $200 million, inflation adjusted by the growth in the consumer price index for all urban consumers (CPI-U) to $207 million for negotiation year 2027),
  • Plasma-derived products, and
  • For 2026 to 2028, “small biotech” drugs (i.e., drugs that account for 1% or less of total Medicare drug spending on all qualifying single source drugs under either Part B or Part D but 80% or more of Part B or Part D spending for a given manufacturer’s Part B or Part D covered qualifying single source drugs).

Policy for Fixed Combination Drugs: To identify potential qualifying single source drugs, the IRA requires aggregating data across dosage forms (such as tablets and capsules) and strengths of a given drug product. However, the law does not address how to handle fixed combination drugs (that is, a drug that includes two or more active ingredients). According to CMS guidance for 2028, data for a fixed combination drug will not be aggregated with data for a drug that includes only one of those active ingredients. Instead, CMS will treat these as distinct drug products for the purposes of identifying potential qualifying single source drugs. CMS has acknowledged the possibility that manufacturers might try to avoid or delay having a drug selected for negotiation by modifying the formulation to add an active ingredient, a “program integrity risk” that CMS stated it plans to address in future rulemaking around the negotiation program for 2029.

The 2025 reconciliation law changed the orphan drug exclusion to delay or make more drugs ineligible for negotiation

Copy link to The 2025 reconciliation law changed the orphan drug exclusion to delay or make more drugs ineligible for negotiation

The IRA excluded orphan drugs from Medicare drug price negotiation if they were designated for only one rare disease or condition with approvals under that one designation. The 2025 reconciliation law broadened the orphan drug exclusion in two ways: 1) making orphan drugs that are designated for multiple rare diseases or conditions, not just a single rare disease, ineligible for Medicare drug price negotiation; and 2) delaying the start of the 7- or 11-year period before a drug can be selected for price negotiation for orphan drugs that subsequently receive FDA approval for a non-orphan indication.

These changes likely had an impact on which drugs were selected for Medicare price negotiation for 2028 by delaying the selection of the biologic drugs Keytruda and Opdivo, which were likely to have been selected for negotiation in 2026 based on their total Medicare spending levels and meeting other statutory criteria. In 2023, Medicare and beneficiaries spent $5.6 billion on Keytruda and $2.0 billion on Opdivo. Both drugs were initially approved as orphan drugs in 2014 and subsequently approved for non-orphan indications beginning in 2015. However, due to the change in law, the time that they were on the market as orphan-only drugs no longer counts towards the 11-year period following FDA licensure that biologics become eligible for the negotiation program. Therefore, selection of Keytruda and Opdivo for Medicare drug price negotiation has been delayed beyond 2026. Overall, the provision in the reconciliation law that delays or excludes additional orphan drugs from Medicare drug price negotiation will cost the federal government $8.8 billion over the coming decade, according to CBO, and will also mean higher out-of-pocket costs for Medicare beneficiaries who use these medications.

Drugs selected for negotiation are chosen from the top-ranking qualifying negotiation eligible drugs based on total Medicare Part B and Part D spending

Copy link to Drugs selected for negotiation are chosen from the top-ranking qualifying negotiation eligible drugs based on total Medicare Part B and Part D spending

The 15 Part B and Part D drugs that were selected for price negotiation for 2028 were chosen from the top 50 negotiation-eligible Part D drugs with the highest total Medicare Part D expenditures and the top 50 negotiation-eligible Part B drugs with the highest total Medicare Part B expenditures. For this purpose, total Part D expenditures are defined as total gross covered prescription drug costs from Part D prescription drug event (PDE) data, and total Part B expenditures are for separately payable Part B covered drugs (that is, not bundled or packaged into the payment for another service, such as anesthesia drugs, or most drugs used in treatment of end-stage renal disease) and include traditional Medicare claims data and Medicare Advantage encounter data. (Since encounter data do not include spending amounts, CMS estimates spending on Part B drugs in Medicare Advantage based on what would have been paid in traditional Medicare.)

To derive these lists, CMS first identified the qualifying single source drugs among all covered Part B and Part D drugs, applying the relevant statutory exclusions (as described above). CMS then calculated total expenditures for each qualifying drug separately under Part B and Part D, based on spending data for the 12-month period from November 1, 2024 to October 31, 2025. The top 50 Part B drugs and the top 50 Part D drugs with the highest total expenditures for this 12-month period were the negotiation-eligible drugs for 2028. CMS combined total expenditures under Part B and Part D for each negotiation-eligible drug (where applicable), ranked negotiation-eligible drugs by total spending, and selected the 15 highest-ranked drugs. (Drugs already selected for negotiation in previous rounds are removed from the list of qualifying single source drugs prior to ranking.)

The IRA provides for a delay in selecting drugs for negotiation if they are biological products where there is a “high likelihood” of biosimilar market entry within two years of the publication date of the selected drug list. The rationale for this delay is to not create financial incentives that could deter biosimilars from entering the market if, for example, a reference product (the original biological product approved by FDA against which a proposed biosimilar product is compared) is selected for negotiation and ultimately priced lower than potential competitor biosimilar products. CMS announced that for 2028, when selecting the 15 highest-ranked Part B and Part D drugs, no products qualified for delayed selection based on a high likelihood of biosimilar market entry.

Drugs that were previously selected for negotiation can be selected for renegotiation under certain circumstances

Copy link to Drugs that were previously selected for negotiation can be selected for renegotiation under certain circumstances

In addition to the 15 drugs selected for negotiation for 2028, CMS announced that one drug (Tradjenta) has been selected for renegotiation. This drug was initially included on the list of drugs selected for price negotiation in January 2025 (see Table 3 below). CMS identifies renegotiation-eligible drugs from the list of drugs previously selected for negotiation based on: (1) a change in status to “long-monopoly” (that is, at least 16 years have passed since the date of FDA approval or licensure, which would affect the ceiling price that applied during the negotiation process; such drugs are automatically selected for renegotiation); (2) the availability of new indications; or (3) a material change in the factors that CMS uses in negotiating drug prices that could meaningfully affect the outcome of renegotiation relative to the original negotiation process. In determining whether a renegotiation-eligible drug will be selected for renegotiation, CMS will evaluate whether a new indication or a material change in negotiation factors will result in a 15% or greater change in the negotiated price (higher or lower) and whether that would have a significant impact on the Medicare program.

The annual timeline for Medicare drug price negotiation begins with the announcement of selected drugs by February 1 and ends with the announcement of negotiated prices by November 30

Copy link to The annual timeline for Medicare drug price negotiation begins with the announcement of selected drugs by February 1 and ends with the announcement of negotiated prices by November 30

The annual timeline of key activities in the negotiation process begins no later than February 1 of a given year when the list of selected drugs is announced and ends no later than November 30, the statutory deadline for CMS to announce negotiated prices for selected drugs (Figure 1). The price negotiation process between CMS and drug manufacturers spans several months between spring and fall.

Timeline of Key Activities Under the Medicare Drug Price Negotiation Program For Initial Price Applicability Year 2028 (Scatter Plot)

CMS is required to consider certain manufacturer-specific factors and information about therapeutic alternatives in its price negotiations

Copy link to CMS is required to consider certain manufacturer-specific factors and information about therapeutic alternatives in its price negotiations

The IRA requires CMS to consider certain manufacturer-specific factors and information about therapeutic alternatives to selected drugs in negotiating the “maximum fair price” (MFP) for selected drugs, although the law does not specify how CMS should weigh these different elements in the process of developing its offer for the maximum fair price.

The manufacturer-specific factors related to selected drugs include:

  • The manufacturer’s research and development costs and the extent to which the manufacturer has recouped these costs.
  • The current unit costs of production and distribution.
  • Federal financial support for novel therapeutic discovery and development related to the drug.
  • Data on pending and approved patent applications, exclusivities, and certain other applications and approvals.
  • Market data and revenue and sales volume data in the U.S.

For the manufacturers of the 15 selected drugs for 2028, these data elements are required to be reported to CMS by March 1, 2026.

Information about therapeutic alternatives includes:

  • The extent to which the selected drug represents a therapeutic advance compared to existing therapeutic alternatives and the costs of these alternatives.
  • Prescribing information for the selected drug and its therapeutic alternatives, which may include generics or biosimilars.
  • Comparative effectiveness of the selected drug and its therapeutic alternatives, taking into account their effects on specific populations, such as individuals with disabilities, the elderly, the terminally ill, children, and other patient populations.
  • The extent to which the selected drug and its therapeutic alternatives address unmet needs for a condition that is not adequately addressed by available therapy.

According to CMS guidance, information on these factors may be submitted by several entities, including the manufacturer of the selected drug, other drug manufacturers, people with Medicare, academic experts, clinicians, and others. Submissions are due by March 1, 2026 for the selected drugs for 2028. In addition to evaluating the information in these submissions, CMS will review the literature and real-world evidence, conduct internal analysis, and consult with experts regarding evidence of the clinical benefits of the selected drugs and their therapeutic alternatives.

The IRA explicitly directs that the HHS Secretary “shall not use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, non-disabled, or not terminally ill.” In other words, the use of health outcomes evidence based on quality-adjusted life years (QALYs) in the process of negotiating a maximum fair price is not permitted.

CMS determines its initial offer for the negotiated price of a selected drug based in part on the price of therapeutic alternatives, information about clinical benefits, and manufacturer-specific data

Copy link to CMS determines its initial offer for the negotiated price of a selected drug based in part on the price of therapeutic alternatives, information about clinical benefits, and manufacturer-specific data

To determine its initial offer for a maximum fair price for a selected drug, CMS: (1) identifies therapeutic alternative(s) for the selected drug; (2) determines pricing information about the therapeutic alternatives to determine the starting point for the initial offer; (3) adjusts the initial offer based on information about the clinical benefit of the selected drug compared to its therapeutic alternatives; and (4) makes further adjustments to the offer price as needed based on manufacturer-specific data to determine the initial offer price. (The IRA does not include international drug price data as a benchmark to be used in CMS’s initial pricing decisions or the negotiation process overall.)

CMS uses the price of therapeutic alternative(s) as the starting point for determining the initial offer for the maximum fair price for a given selected drug. Specifically, for the 2028 negotiation year, CMS will use the lower of: for Part D drugs, the net Part D plan payment and beneficiary liability, which excludes both rebates as well as Manufacturer Discount Program payments, the wholesale acquisition cost (WAC), or the maximum fair price negotiated for previously selected drugs if any are therapeutic alternatives for 2028 selected drugs; and for Part B drugs, the average sales price (ASP) or WAC. If there is more than one therapeutic alternative for a selected drug, CMS will determine the starting point within the range of prices for those products.

For selected drugs with no therapeutic alternative or where the price of the alternative(s) is above the ceiling price, CMS will use the Federal Supply Schedule (FSS) or “Big Four Agency” price as the starting point, whichever is lower. (Drug prices listed on the FSS, which establishes prices available to all direct federal purchasers, are determined through both statutory rules and negotiation. A statutory cap on drug prices for the Big Four agencies (the Department of Veterans Affairs, the Department of Defense, the Public Health Service, and the Coast Guard) means the prices they pay are generally lower than prices paid by other direct federal purchasers.) If the FSS or Big Four prices are above the statutory ceiling, CMS will use the statutory ceiling as the starting point for its initial offer.

CMS will adjust the starting point for the initial offer based on a broad evaluation of evidence, including that which is submitted by manufacturers and the public, about the clinical benefit the selected drug provides relative to its therapeutic alternatives, including information about potential safety concerns and side effects, whether the selected drug represents a therapeutic advance as measured by improvements in clinical outcomes, and information about the effects of the selected drug and its therapeutic alternatives on specific populations, including people with disabilities and older adults. CMS will also consider comparative effectiveness data on patient-centered outcomes and patient experiences.

If a selected drug has no therapeutic alternatives, CMS will evaluate evidence about the selected drug’s clinical benefit, including improvements in outcomes, and also will consider the extent to which the selected drug fills an unmet medical need, meaning the drug treats a disease or condition where there are very limited or no other treatment options, or the existing treatments do not adequately address the disease or condition. This consideration will be made separately for each indication of a selected drug, where applicable.

After considering information about clinical benefit, CMS will adjust its starting point for the initial offer price to arrive at a “preliminary price.” After determining the preliminary price, CMS will take into account manufacturer-specific data elements. These data, and their illustrative effect on the preliminary price as described in CMS’s guidance, are:

  • Research and development (R&D) costs: if a manufacturer has recouped its R&D costs, CMS could adjust the preliminary price downward, or upward if such costs have not been recouped.
  • Current unit costs of production and distribution: if lower than the preliminary price, CMS could adjust the price downward, or upward if such costs are higher than the preliminary price.
  • Prior federal financial support: if discovery and development of the selected drug was supported by federal funding, CMS could adjust the preliminary price downward.
  • Patent information: this data will support CMS’s evaluation of whether a selected drug represents a therapeutic advance or meets an unmet medical need, particularly in light of any exclusivities which mean that a selected drug is the only available therapy.
  • Market data and revenue and sales volume data for the drug in the U.S.: depending on how CMS’s preliminary price compares to other market pricing data for the selected drug, CMS could, for example, revise downward the preliminary price if the average commercial net price is lower, or upward if the average commercial net price is higher.

After making any necessary adjustments to the preliminary price based on a review of manufacturer-specific data, CMS will arrive at its initial offer for the maximum fair price.

The law establishes a ceiling on the negotiated price that Medicare will pay for selected drugs, based on existing price benchmarks

Copy link to The law establishes a ceiling on the negotiated price that Medicare will pay for selected drugs, based on existing price benchmarks

The IRA establishes an upper limit for the maximum fair price for a given drug, which varies depending on whether the drugs is covered under Part B only, Part D only, or both parts. The upper limit is the lower of the drug’s enrollment-weighted negotiated price (net of all price concessions, including rebates) for a Part D-only drug, the average sales price (the average price to all non-federal purchasers in the U.S., inclusive of rebates, other than rebates paid under the Medicaid program) or a percentage of a drug’s average non-federal average manufacturer price (non-FAMP) (the average price wholesalers pay manufacturers for drugs distributed to non-federal purchasers) for a Part B-only drug, or a weighted average of these amounts for drugs covered under both Part B and Part D. The percentage of non-FAMP varies depending on the number of years that have elapsed since FDA approval or licensure: 75% for small-molecule drugs and vaccines more than 9 years but less than 12 years beyond approval; 65% for drugs between 12 and 16 years beyond approval or licensure; and 40% for drugs more than 16 years beyond approval or licensure. This approach means that the longer a drug has been on the market, the lower the ceiling on the maximum fair price.

The negotiation process between CMS and drug manufacturers spans several months and allows for multiple opportunities to exchange price offers

Copy link to The negotiation process between CMS and drug manufacturers spans several months and allows for multiple opportunities to exchange price offers

CMS’s guidance outlines several steps in the negotiation process (Figure 1). These steps, and the relevant dates for selected drugs for 2028, are:

  • CMS and manufacturers of selected drugs enter into a written agreement to negotiate to determine the maximum fair price for selected drugs by February 28, 2026.
  • Submission of economic and market data from manufacturers of selected drugs to CMS and information about therapeutic alternatives is due on March 1, 2026.
  • CMS will host one meeting with manufacturers of selected drugs in Spring 2026 after the submission of manufacturer-specific data elements so that manufacturers can provide additional context for their data submission and share new information, if applicable.
  • CMS will host up to 15 patient-focused roundtable events with consumer and patient organizations (with selected drugs aggregated by condition, as appropriate) and one clinician-focused town hall event in Spring 2026 to solicit patient-focused and clinical information on therapeutic alternatives and other information for CMS to consider in developing its initial offer for selected drugs.
  • CMS will make a written offer to the manufacturer of a selected drug with its initial offer of the maximum fair price by June 1, 2026. This written offer will include a justification for CMS’s initial offer based on the methodology used, including how CMS evaluated various data submitted by manufacturers and evidence about alternative therapies.
  • An optional negotiation meeting between CMS and manufacturers of selected drugs could take place between the date of CMS’s initial offer and the deadline for manufacturers to respond.
  • Manufacturers respond to CMS’s initial offer in writing either accepting the offer or making a counteroffer within 30 days of receiving the initial offer (e.g., July 1, 2026, for initial offers made by CMS on June 1, 2026). The written counteroffer should include the manufacturer’s proposed maximum fair price, along with a justification for that amount and a response to CMS’s justification for its initial offer. If the manufacturer does not accept CMS’s initial offer, a written counteroffer must be submitted, If the manufacturer accepts CMS’s initial offer, the negotiation process ends.
  • CMS will provide a written response to the manufacturer in response to an optional written counteroffer, either accepting or rejecting the counteroffer, within 30 days (e.g., July 31, 2026, if the manufacturer’s counteroffer is made on July 1, 2026). If CMS accepts the manufacturer’s counteroffer, the negotiation process ends.
  • If CMS rejects the manufacturer’s counteroffer, up to 2 additional in-person or virtual meetings could occur between CMS and the manufacturer to discuss offers and counteroffers. The meetings would focus on manufacturer-submitted data and information about therapeutic alternatives, and how that information should factor into the maximum fair price. The timeframe for negotiation meetings would end no later than September 11, 2026. Additional written offers and counteroffers could be exchanged after CMS’s rejection of the manufacturer’s counteroffer and final agreement on the maximum fair price (up to one week prior to CMS submitting a final written offer).
  • After any negotiation meetings between CMS and the manufacturer, CMS makes a final written offer for the maximum fair price (no later than September 30, 2026 for the 2028 negotiation cycle).
  • Manufacturers consider CMS’s final offer and either accept or reject the offer in writing (by October 31, 2026 for the 2028 negotiation cycle).
  • The negotiation process ends when CMS and manufacturers of selected drugs reach agreement on the maximum fair price, but no later than the statutorily defined deadline for the negotiation process to end (October 31, 2026 for the 2028 negotiation cycle) and the end of the negotiation period (November 1).

If an agreement on the maximum fair price is not reached by the October 31 deadline, manufacturers may be subject to an excise tax, which is being administered by the IRS, as specified in the Inflation Reduction Act. CMS has outlined an expedited process manufacturers can follow if they choose to not participate in the negotiation program, which would enable them to withdraw their drugs from coverage under Medicare and Medicaid to avoid paying the excise tax.

According to CMS, manufacturers may disclose information related to the negotiation process with CMS if they choose to do so. CMS will not publicly discuss the specifics of the negotiation process related to any manufacturer but reserves the right to do so if manufacturers themselves choose to disclose this information.

The marketing of a generic or biosimilar version of a drug previously selected for negotiation affects the availability of the negotiated price for that product

Copy link to The marketing of a generic or biosimilar version of a drug previously selected for negotiation affects the availability of the negotiated price for that product

Drugs are not eligible to be selected for negotiation if there is a generic or biosimilar using that drug as the reference product approved or licensed by the FDA and being marketed. (Authorized generics do not count for this purpose, since they are not technically generic drugs as that term is commonly used, but rather the same drug product as the brand-name drug with a different label.) If a drug has already been selected for negotiation and CMS determines that a generic or biosimilar drug has been approved or licensed and is being “bona fide” marketed (as described above) – either before or during the negotiation process – the negotiation process will not start or will be suspended. The drug will continue to be a selected drug (not replaced by another drug), but no maximum fair price will be negotiated. To be removed from the list of selected drugs for 2028, CMS will need to make this determination between February 1, 2026 and November 1, 2026 (between the selected drug publication date and the end of the negotiation period.)

If CMS determines that a generic or biosimilar drug has been approved and marketed after a drug has been selected for negotiation and after a maximum fair price has been established, the maximum fair price will take effect, but depending on when the determination is made, that drug will no longer be a selected drug and the maximum fair price will not apply in subsequent years. For selected drugs for 2028, if the determination of generic drug availability is made between November 2, 2026 and March 31, 2028, the maximum fair price will only apply in 2028 and the drug will no longer be a selected drug for 2029; if the determination is made between April 1, 2028 and March 31, 2029, the maximum fair price will apply in 2028 and 2029 and the drug will no longer be a selected drug for 2030.

Potential savings for Medicare beneficiaries from Medicare’s negotiated drug prices depend on several factors

Copy link to Potential savings for Medicare beneficiaries from Medicare’s negotiated drug prices depend on several factors

There is uncertainty about how many Medicare beneficiaries will see lower out-of-pocket drug costs in any given year under the Medicare price negotiation program and the magnitude of potential savings, since both will depend on which drugs are subject to the negotiation process and the price reductions achieved through the negotiation process relative to what prices would otherwise be. In addition, whether Part D enrollees pay lower out-of-pocket costs for a given Part D selected drug will depend in part on whether they pay flat copayment amounts or a coinsurance rate for the drug in their chosen Part D plan. If they pay coinsurance, they could see savings from a Medicare-negotiated price that is lower than their plan’s negotiated price. This applies for Part B selected drugs as well, where beneficiaries in both traditional Medicare and Medicare Advantage typically face a coinsurance rate of 20% (although many beneficiaries in traditional Medicare have supplemental coverage that helps with Medicare cost-sharing requirements).

Aside from the potential for out-of-pocket cost savings, the drug price negotiation program could improve Medicare Part D enrollees’ access to Part D drugs that are selected for negotiation, since the IRA requires Part D plans to cover all selected drugs with negotiated maximum fair prices, including all dosage forms and strengths. (Part D plans generally can choose which drugs to cover and not cover on their formularies, subject to CMS’s formulary guidelines and requirements, except for drugs in six called “protected classes,” where all or substantially all drugs must be covered.) KFF analysis of 2026 Medicare Part D formulary coverage of drugs selected for negotiation shows that the IRA’s coverage requirement for selected drugs led to improved coverage of the Part D drugs with negotiated prices available in 2026.

CMS will use the annual formulary review process to ensure that all Part D plans cover all dosages and formulations of selected drugs. CMS will also review whether Part D plan sponsors place selected drugs on non-preferred tiers; place selected drugs on a higher tier than non-selected drugs in the same class; require utilization of an alternative brand prior to a selected drug; or impose more restrictive utilization management tools on a selected drug relative to a non-selected drug in the same class. In any such instances, CMS expects Part D plan sponsors to provide a clinical justification for these practices and will only approve those formularies that adhere to all statutory and regulatory guidelines and requirements.

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

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