In a landmark case earlier this year, K.G.M. v. Meta Platforms, Inc. et al., a jury held major social media platforms responsible for the mental health harm of an adolescent due to their platforms’ addictive design features. This case underscores growing concerns about adolescent mental health and substance use and draws attention to the factors that may be linked to these concerns. In recent years, a large share of adolescents reported heavy screen time and social media use, trauma exposure – including direct and indirect exposure to gun violence – loneliness, and sleep deprivation. These experiences are tied to poor mental health outcomes, including anxiety and depression. Meanwhile, suicide death rates remain high among adolescents and overdose deaths reached record numbers amid the opioid epidemic.

To address growing mental health and substance use concerns several measures were introduced. This includes the 2022 Bipartisan Safer Communities Act (BSCA), which allocated funds to strengthen school-based mental health services, particularly in high-need areas, and utilize Medicaid to expand youth services. In 2021, the U.S. Surgeon General declared a youth mental health crisis and released an advisory outlining a wide range of recommendations to support this population. However, recent policy actions under the second Trump Administration have rolled back some of these efforts. Funding for school-based mental health services via the BSCA was disrupted, prompting questions about how to retain school mental health providers and reach students in need. Other, large-scale changes to insurance are expected to negatively impact coverage and access to care in the coming years. This includes changes to Medicaid, which provides coverage to nearly 40% of children and teens. Additionally, the President’s budget for 2027 proposes cuts to agencies engaged in mental health and substance use disorder services, including ongoing efforts to restructure SAMHSA. SAMHSA also oversees the 988 crisis hotline – which was recently linked to decreased adolescent suicide mortality. Funding for 988 remains flat in 2027, though previous actions have already impacted services, including the removal of an extension line to assist LGBTQ individuals. LGBTQ youth are more likely to experience suicidality compared to their peers.

This brief analyzes the latest data (2024) from the CDC WONDER mortality database and the National Survey on Drug Use and Health to examine the prevalence of adolescent mental health conditions and substance use, related deaths, and access to behavioral health services.

1. Despite some modest improvements, many adolescents experience poor mental health and substance use issues.

In 2024, 15% of adolescents (or 3.8 million) reported a past year major depressive episode (MDE) and 19% (or 4.9 million) reported moderate to severe symptoms of anxiety (Figure 1). The share of adolescents with an MDE decreased from 21% in 2021 during the pandemic – the oldest trend data available – to 15% in 2024. Additionally, a survey of high school students found that the share of students reporting feelings of sadness and hopelessness – which can be indicative of depressive disorder – increased from 30% in 2013 to 42% in 2021, before slightly declining to 40% in 2023. While NSDUH data on anxiety cannot be trended over time, other survey data suggest that diagnosed anxiety has increased over time among adolescents, with prevalence remaining higher than pre-pandemic levels. Anxiety is the most common mental health condition in this population.

In 2024, 7.8% (or 2 million) adolescents reported having a substance use disorder in the past year (Figure 1). This is a slight decrease from the 9.2% of adolescents reporting a past year substance use disorder in 2021 – the oldest trend data available. A prior KFF analysis found that the use of drugs and alcohol among high school students slightly declined from 2017 to 2023, despite the surge in drug overdose deaths during pandemic years.

Among adolescents with mental illness and/or substance use disorder, over half have private insurance and 4 in 10 have Medicaid. However, Medicaid is a major payer for mental health and substance use services for youth. Medicaid can facilitate access to care in schools and its Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit requires coverage of medically necessary services and maintains low out-of-pocket costs.

2. Substance use is higher among adolescents with mental illness compared to adolescents without mental illness.

In 2024, the use of any illicit drug was significantly higher among adolescents with a past year MDE than their counterparts (33% vs. 12%); and among adolescents with symptoms of anxiety than their counterparts (26% vs. 10%) (Figure 2). The co-occurrence of poor mental health and substance use is common. In a CDC convenience sample survey of teens, ages 13 to 18, who used substances in the last 30 days, 40% reported using substances to cope with anxiety or depression.

Marijuana, a drug that is now legally available to adults in many states, has been linked to the onset of psychoticdisordersamong youth, and is used by a large share of adolescents with an MDE (25%) and adolescents with symptoms of moderate to severe anxiety (18%). Adolescents without a past year MDE or anxiety were significantly less likely to report marijuana use (8% and 7%, respectively). Marijuana use among adolescents is associated with earlier onset of psychosis, with more frequent use linked to increased risk of adverse mental health outcomes, including schizophrenia. Further, the presence of the compound THC in marijuana has increased over time and is linked to psychotic symptoms and disorders.

3. Suicide deaths among adolescents are slowly trending downward but remain higher than a decade ago.

In the past decade, adolescent suicide deaths increased and peaked in 2018 (1,750 deaths), followed by a gradual decline through 2024 (1,478 deaths, Figure 3). There was a 5% decrease in adolescent suicide deaths from 2023 to 2024 (1,555 vs. 1,478). These deaths are more prevalent among adolescent males and are more rapidly increasing for adolescents of color compared to their White peers. Although suicide deaths are higher for adolescent males than their peers, serious thoughts of suicide are higher for adolescent females. Data on the suicide deaths was not available by LGBQ+ identity. However, LGBQ+ youth are more likely to report suicidality than their heterosexual peers. It is possible that some suicides are misclassified as drug overdose deaths since it can be difficult to determine whether drug overdoses are intentional.

More than 17,000 adolescents died by suicide over the past decade and over 4 in 10 of these deaths involved a firearm (Figure 3). Access to firearms, particularly in the home, is a risk factor for suicide deaths among children and adolescents. 

4. After surging during the pandemic, drug overdose deaths among adolescents sharply declined in 2024 but remain above pre-pandemic levels.

The sharp decline in drug overdose deaths among adolescents was driven by a reduction in opioid-related deaths: 557 deaths in 2023 vs. 272 in 2024 (Figure 4). Despite decreases in substance use among adolescents, adolescent drug overdose deaths more than doubled during the COVID-19 pandemic. This shift was largely due to drugs laced with opioids, particularly the synthetic opioid, fentanyl. Opioid-related deaths among adolescents jumped from 165 in 2019 to 396 in 2020 and continued to increase for several years before declining by approximately 50% between 2023 and 2024 (from 557 to 272, Figure 5). These trends mirror broader trends in opioid-related deaths across the total U.S. population.

Multiple actions may have contributed to the decline in overdose deaths, including school-based initiatives for youth. Policy actions implemented in response to the opioid epidemic include expanded access to treatment, public awareness campaigns, and improved fentanyl detection. Schools have also responded to the overdose crisis in multiple ways. For example, in the 2024-2025 school year, 52% of public schools offered fentanyl education to students and 77% stored naloxone – a nasal spray to reverse opioid overdose. However, challenges remain, such as adolescents obtaining drugs through social media which may be contaminated with fentanyl.

5. Adolescents receive mental health services in a variety of settings, including schools; however, recent policy changes may affect access in the future.

Six out of ten adolescents with a past year MDE reported receiving mental health treatment in 2024 (Figure 5). Many of these adolescents report receiving outpatient care in a variety of settings, including through telehealth treatment (33%). Thirty-one percent of adolescents with a past year MDE report taking prescription medication (31%).

Approximately 3 in 10 youth with a past year MDE obtain care through school health or counseling services; however, changes in funding put access to school-based mental health services at-risk. During the second Trump Administration, ongoing policy changes may impact youth access to mental health services. This includes rolling back funds to broaden access to mental health and trauma services in schools that were originally allocated through the Bipartisan Safer Communities Act.

Among the 2.4 million adolescents in need of substance use care in 2024, only 30% received treatment. This may be linked to limited access to buprenorphine and residential addiction treatment facilities among this population. Additionally, many residential addiction treatment facilities do not have availability for adolescents and are costly. These facilities often do not provide buprenorphine to adolescents with opioid use disorder.

GLP-1s, a class of drugs used to treat type 2 diabetes, obesity, cardiovascular disease, and other conditions, have exploded in popularity in recent years due to their demonstrated effectiveness, but are often not covered by insurance, particularly for the treatment of obesity. According to KFF polling,  about half (56%) of GLP-1 users say these drugs were difficult to afford, including one in four who say they were “very difficult” to afford. The Trump administration is pursuing various approaches to lowering the cost and expanding coverage of these medications. These approaches include striking “most-favored nation” deals with GLP-1 manufacturers Novo Nordisk and Eli Lilly, providing access to discounted prices for GLP-1s through TrumpRx, and proposing to implement a new demonstration program called the BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model to expand Medicare and Medicaid coverage of GLPs for obesity, which is currently subject to statutory limitations (prohibited in Medicare, permissible but not required in Medicaid). In addition, the GLP-1 drug semaglutide (branded as Ozempic, Wegovy, and Rybelsus) was selected for Medicare drug price negotiation in 2025, with a negotiated price set to take effect in 2027.

This brief describes current coverage of GLP-1s in Medicare and Medicaid, the Centers for Medicare & Medicaid Services’ (CMS) efforts to expand access and lower costs for GLP-1s through temporary demonstration programs, and potential impacts on beneficiaries and program budgets. It also describes recent changes to the administration’s plans for temporary coverage of GLP-1s in Medicare, including an indefinite delay in implementation of the BALANCE Model in Part D and an extension of a separate short-term program, called the Medicare GLP-1 Bridge, which was originally scheduled to run from July-December 2026 but will now run through the end of 2027.

Current law prohibits Medicare from covering obesity drugs and gives states flexibility to cover weight loss drugs under Medicaid

Limitations on coverage for obesity drugs in Medicare and Medicaid mean that millions of people who have obesity and might benefit from taking GLP-1s may be unable to access them unless they are able to pay the full cash price out of their own pockets, which would likely be prohibitive for people with Medicaid who must have low incomes to qualify for the program, as well as for many people on Medicare with low and modest incomes. Under the Medicare Part D outpatient prescription drug benefit program, Part D plans are required to cover a minimum of two drugs in each therapeutic category and class, but from the outset, Medicare has been prohibited by law from covering medications when used specifically for weight loss. People on Medicare can get GLP-1s covered by Part D plans only if they are used for a medically accepted FDA-approved indication other than obesity, like type 2 diabetes, cardiovascular disease risk reduction, or sleep apnea.

Under the Medicaid Drug Rebate Program (MDRP), state Medicaid programs must cover nearly all of a participating manufacturer’s FDA-approved drugs for medically accepted indications. However, federal law gives states the option whether to cover drugs used for weight loss. As a result, GLP-1 coverage for medically accepted FDA-approved indications other than obesity is required while access to GLP-1s to treat obesity under Medicaid is currently limited. Only 13 states provided coverage as of January 2026, down from 16 states in 2025, likely reflecting the significant costs of coverage and recent state budget challenges and federal funding cuts.  

Even with these coverage limits on obesity drugs in place, utilization and gross spending on GLP-1 drugs for approved uses in Medicare and Medicaid have increased considerably in recent years. In 2024, there were 8.4 million prescriptions and $8.6 billion in spending on GLP-1s in Medicaid, and 21.8 million claims and $27.5 billion in gross spending (not excluding rebates) on GLP-1s in Medicare (Figure 1).

CMS is proposing temporary expansions of Medicare and Medicaid coverage of GLP-1s for obesity through demonstration programs

CMS initially proposed a two-step approach to expanding coverage of GLP-1s for obesity in Medicare – a temporary payment demonstration for 2026, known as the Medicare GLP-1 Bridge, and a new Center for Medicare and Medicaid Innovation (CMMI) model, known as the BALANCE Model, that was originally scheduled to begin in January 2027 and end in December 2031. CMS has recently announced an indefinite delay in implementation of the BALANCE Model, however, and an extension of the GLP-1 Bridge through the end of 2027 (as described below).

For Medicaid, GLP-1 coverage will be expanded through the BALANCE Model beginning in May 2026 and ending in December 2031. (See Figure 2 for a timeline of key activities associated with the GLP-1 coverage demonstrations.)

Medicare coverage of GLP-1s for obesity begins in July 2026 through the Medicare GLP-1 Bridge and will be extended through the end of 2027

CMS will provide Part D beneficiaries with coverage of select GLP-1s for obesity from July 1, 2026 to December 31, 2027 (originally December 31, 2026) through the Medicare GLP-1 Bridge, which is a short-term demonstration established using Section 402 demonstration authority. The Medicare GLP-1 Bridge is a nationwide demonstration program that will be separate from Part D coverage, meaning Part D sponsors will not have to opt into the demonstration for eligible beneficiaries to gain access, nor will Part D sponsors bear any financial risk for costs incurred by their enrollees associated with the demonstration.

Medicare beneficiaries enrolled in Part D plans who meet the eligibility criteria will have access to GLP-1 medications approved for weight reduction (all formulations of both Foundayo and Wegovy and the KwikPen formulation of Zepbound) at a copayment of $50 per month. For a beneficiary to qualify, their provider must submit a prior authorization request that attests the beneficiary is being prescribed the drug to reduce excess body weight and ongoing maintenance of weight reduction and that they fall into one of three categories related to BMI and other clinical diagnostic criteria (Figure 3).

Manufacturers have agreed to provide eligible GLP-1s under the Bridge program at a net price of $245 per month supply. When participating beneficiaries fill a prescription for one of these drugs, pharmacies will collect the $50 copayment and submit claims to a central processor for reimbursement. Pharmacies will be reimbursed by CMS at no lower than the wholesale acquisition cost (WAC) of a drug, less the beneficiary copay, plus a dispensing fee and, as applicable, sales tax. Manufacturers will then owe money back to CMS for the difference between the WAC and the negotiated $245 net price.

Because this payment demonstration operates outside coverage under a Part D plan, the $50 copayment toward these medications will not count toward a participating beneficiary’s Part D deductible or the $2,100 out-of-pocket maximum in 2026 (increasing to $2,400 in 2027), and copayments will stay consistent at $50 per month, regardless of the Part D benefit phase a beneficiary is in when they fill the prescription. Medicare beneficiaries who are already receiving coverage from their Part D plan for a GLP-1 for a Medicare-covered use, such as type 2 diabetes, cardiovascular disease risk reduction, or sleep apnea, will continue to access the drug through their Part D plan and not through the Medicare GLP-1 Bridge, which will only provide coverage of GLP-1s when used for obesity.

For beneficiaries enrolled in the Low-Income Subsidy (LIS) program, the LIS cost-sharing subsidies will not apply in the Medicare GLP-1 Bridge. This may make it more difficult for low- and modest-income beneficiaries who are otherwise eligible to participate to take advantage of coverage under the short-term demonstration in 2026 and 2027 if the $50 monthly copayment is unaffordable.

At this time, it is uncertain how participating beneficiaries will be able to maintain Medicare coverage of their GLP-1 medication for obesity after the Medicare GLP-1 Bridge ends at the end of 2027, pending further action from CMS to implement the BALANCE Model in Medicare Part D in 2028, as described below.

The BALANCE Model was designed to expand coverage of GLP-1s for obesity in Medicaid and Medicare Part D

According to CMS, the BALANCE Model aims to increase access to GLP-1 medications and healthy lifestyle interventions to help people on Medicare and Medicaid improve their overall health. Under this model, CMS negotiated with manufacturers of GLP-1s to provide lower prices to the state Medicaid programs and Medicare Part D plans that choose to participate in the model. For beneficiaries to be eligible under the BALANCE Model, providers must attest that they meet certain clinical criteria, including qualifying for a GLP-1 for a currently covered use (such as type 2 diabetes, cardiovascular disease risk reduction, or sleep apnea) or for use to treat obesity based on similar clinical criteria as applied in the Medicare GLP-1 Bridge (Figure 3).

In addition to offering lower prices for GLP-1s, this model will provide patients with access to lifestyle support programs at no cost, which are intended to support medication adherence as well as increase GLP-1 effectiveness. (Details about these programs are not yet available.) These lifestyle support programs will be provided by participating manufacturers. As part of their agreements with CMS, the manufacturers must demonstrate how these lifestyle support programs will meet the program requirements, including encouraging healthy eating and increasing physical activity, supporting medication adherence, ensuring engagement with the program on a regular basis, and ensuring availability of this program to all patients receiving these medications, either online or offline for those who have limited digital access. However, prescribing providers will not be required to document that patients are actively participating in these lifestyle support programs as part of attesting to their eligibility for the model based on other clinical criteria.

Participation in the BALANCE Model is voluntary for drug manufacturers, state Medicaid programs, and Medicare Part D plans, but there was insufficient interest among Medicare Part D plans to move forward in 2027

Participation in BALANCE is voluntary for drug manufacturers, state Medicaid agencies, and Medicare Part D plans. The date for manufacturers to notify CMS of their interest in participating was January 8, 2026; for Medicare Part D plans was April 20, 2026; and for state Medicaid programs is July 31, 2026 (Figure 2).

On April 21, 2026, the day after the application deadline for Medicare Part D plan sponsors to participate in the BALANCE Model, CMS announced that it would not be moving forward with implementation of the BALANCE Model in Medicare in 2027 and instead would be extending the Medicare GLP-1 Bridge to run through the end of 2027. CMS said that this was in part to allow for collection of additional data on GLP-1 utilization to share with Part D plan sponsors ahead of potential implementation of BALANCE in Part D. CMS also stated they received feedback from plans that an extension of the BRIDGE would facilitate a smoother transition to potential implementation of BALANCE in Part D. At the same time, it was also reported that major Part D plan sponsors were reluctant or unwilling to participate in the BALANCE Model as it was originally designed. The discussion below of Medicare Part D participation in BALANCE reflects implementation details under CMS’s original design. However, implementation of this model in Medicare faces an uncertain future, since CMS has not yet announced specific plans to restart or restructure the model for future years. The delay in implementation of the BALANCE Model within Medicare Part D will not affect plans for implementation of the model within Medicaid beginning in 2026.

Drug Manufacturers

During the model pre-implementation period in early 2026, CMS negotiated with Novo Nordisk and Eli Lilly to come to agreement on the key parameters of the model, including details about pricing of the model drugs, cost sharing, rebate calculations, access policies (i.e., coverage criteria and prior authorization policies), the length of the agreement, data sharing arrangements, and agreement on lifestyle supports that will be offered. Both manufacturers have agreed to participate in the model, and the following medications will be included: all formulations of Foundayo, Mounjaro, Ozempic, Rybelsus, and Wegovy, and the KwikPen formulation of Zepbound. The manufacturers have agreed to a $245 net price per 30-day supply for all model drugs in 2027 for the Medicare program though the net price for state Medicaid programs is confidential to the public. CMS and manufacturers may renegotiate terms in the future depending on certain circumstances such as changes in the FDA labeling, new clinical evidence, or new products launched.

State Medicaid Programs

Participation. For state Medicaid agencies that opt to participate in the model, implementation will be on a rolling basis from May 1, 2026 through January 1, 2027. To participate in the model, state Medicaid programs must sign a State Agreement with CMS and then adopt supplemental rebate agreements (SRAs) with each participating manufacturer that reflects the standard key terms that the participating manufacturers and CMS have agreed to. While states typically develop their own utilization management strategies, the model key terms establish standardized coverage criteria (Figure 3). States may offer broader coverage but cannot make coverage criteria more restrictive, and the Medicaid key terms must apply equally in both fee-for-service and Medicaid managed care. Although the Medicaid component of the BALANCE Model will launch May 1, the deadline for the state Medicaid agency Request for Applications (RFA) is July 31, 2026.

Cost. The discounted GLP-1 net price for state Medicaid programs will be available through additional supplemental rebates (on top of statutory rebates through the MDRP). To participate in the model, state Medicaid programs must terminate or update any existing SRAs with participating manufacturers. While the original announcement of the MFN deals with Eli Lilly and Novo Nordisk noted Medicaid programs would also have access to the $245 price available to Medicare, the final negotiated discounted price available to state Medicaid programs mentioned in the state Medicaid RFA is not available to the public, only participating states. The model will not affect out-of-pocket costs for Medicaid enrollees, which are limited to nominal amounts under federal law.

Medicare Part D Plans

Participation. Part D plan sponsors needed to apply to participate in the model by April 20, 2026. Participants could include sponsors of Part D stand-alone prescription drug plans (PDPs) and Medicare Advantage prescription drug plans (MA-PDs), including Special Needs Plans (SNPs), and employer plans that offer Part D. Eligible plan types exclude Defined Standard benefit plans, which charge a standard 25% coinsurance amount for all covered drugs and do not vary cost sharing by drug type or formulary tier, although plan sponsors could indicate if they wished to convert a Defined Standard benefit plan to another basic benefit type in order to become eligible. Participation was defined at the plan sponsor level, and plan sponsors could choose which of their specific plan benefit packages would be part of the model. However, CMS required plan sponsor participants to include all of their enhanced alternative plans and 90% of their enrollment in basic plans.

CMS was aiming for a “critical mass” of Part D sponsors to participate and established a threshold participation rate of 80% for 2027. This participation rate was to be calculated as the enrollment in Part D plans applying to participate in the model divided by the total enrollment in all Part D plans, excluding special needs plans and employer plans, even though they are eligible to participate in the model, but including Defined Standard benefit plans, even though they are ineligible to participate. (This calculation could produce a different participation rate than if it was based on enrollment in all participating plans divided by enrollment in all plans eligible to participate. CMS did not explain the rationale behind their approach.) CMS specified that if the 80% threshold was not met, CMS would not move forward with the BALANCE Model in Medicare in 2027, and that appears to be what occurred, as CMS’s April 21, 2026 announcement suggests.

Cost sharing. Part D plans must adopt specific cost-sharing limits under the basic benefit plan structure as agreed upon by CMS and manufacturers. Cost sharing for model drugs will be limited to $245 for a 30-day supply in the deductible phase and a lower amount in the initial coverage phase: $50 per month for enhanced plans and employer group plans and $125 per month for basic plans (though plan sponsors can choose to apply lower cost-sharing amounts to model drugs as long as they do so uniformly across all model drugs). Once beneficiaries reach their out-of-pocket maximum (set at $2,400 in 2027), they will pay $0 for their medications, including for model drugs. Part D plans participating in the model are required to place all model drugs on the same formulary tier, cover all medically accepted indications for model drugs, and apply the same cost sharing to all indications.

Participation incentives. Because the model was voluntary for Part D plan sponsors, CMS designed financial incentives to encourage plan participation. The primary approach to encourage participation for 2027 involved an optional narrowing of the risk corridor thresholds to reduce the range of spending where PDPs bear full risk for actual costs higher than their bids (Figure 4). Model participants would qualify for this additional financial protection if they opted in and had higher-than-average utilization of model drugs relative to other similar plan participants. CMS initially stated that for future model years, the agency was considering additional payment incentives, including higher direct subsidy payments based on an adjustment factor to the beneficiary risk score in participating plan bids.

Millions of people with Medicare and Medicaid could benefit from expanded coverage of GLP-1s for obesity

Overall, CMS’s efforts to expand Medicare and Medicaid coverage of GLP-1s for people with Medicare and Medicaid could greatly expand access to these drugs, albeit on a temporary basis, depending on the level of participation by drug manufacturers, state Medicaid agencies and Part D plans. In addition to providing coverage of these drugs for obesity, which would be a new indication in Medicare and in most states under Medicaid, these efforts will also allow beneficiaries in participating states and Part D plans to access GLP-1s for obesity at a lower out-of-pocket cost than if they were to purchase them with cash at the direct-to-consumer prices offered by the manufacturers. Additionally, this model will provide access to a lifestyle support program to promote healthy behaviors and increase the effectiveness of GLP-1s, which could provide improvements in health along with sustained weight reduction.

However, there are factors that could limit the reach of these temporary programs for both the Medicaid and Medicare populations. For example, if the level of participation by state Medicaid agencies is relatively low, the impact of this model for Medicaid recipients may not be very far reaching. In addition, state Medicaid agencies can choose to participate in the model initially but then decide to drop out of the model in later years, which could result in disruptions in coverage. And there is no clear path forward for GLP-1 coverage in Medicare after 2027 if the Medicare GLP-1 Bridge is not extended further and the BALANCE Model is not implemented. This sets up the possibility that Medicare beneficiaries could have coverage of GLP-1s for obesity under the Medicare GLP-1 Bridge in the latter half of 2026 and 2027 but then lose access in 2028 if the BALANCE Model or another coverage pathway are not implemented.

If the BALANCE Model launches in some future year with at least 80% participation, Part D plans could drop out of the model before the final year (originally 2031), which could interrupt treatment, or require frequent plan changes for Medicare Part D enrollees to maintain access. It is also unclear whether Part D plan sponsors would be able continue to cover GLP-1 drugs for the treatment of obesity once the model ended if Medicare’s statutory exclusion on weight loss drugs is not lifted.

Another uncertainty for Part D enrollees in terms of their out-of-pocket costs is the impact of the BALANCE model on Part D premiums. Participating plan sponsors would factor the cost of the model into their bids. That could have the effect of increasing Part D premiums across the board, although Medicare Advantage plans can use rebates to buy down Part D premiums, but this is not an option for stand-alone PDPs. It is possible that CMS could modify the parameters of the Part D PDP premium stabilization demonstration to provide greater premium subsidies for PDP plan sponsors that participate in the BALANCE Model. The ultimate effect on Part D plan bids and premiums is unknown at this time.

The potential federal and state budgetary impacts of expanded coverage of GLP-1s for obesity in Medicare and Medicaid are unknown

CMS documentation does not include potential federal or state budgetary impacts from either the BALANCE Model or the Medicare GLP-1 Bridge. Spending on GLP-1 drugs for currently covered uses under Medicare and Medicaid has increased substantially in a relatively short period of time and could increase further with expanded coverage of GLP-1s for obesity, even at the lower net prices for these medications under both demonstrations. The cost to Medicare of covering obesity drugs under Part D has been estimated at between $25 billion and $35 billion over 10 years, which could have been a driving factor in the reluctance or unwillingness of major Part D plan sponsors to participate in the BALANCE model as it was originally designed. The cost to Medicaid of covering obesity drugs has been estimated at $15 billion, with the federal government paying $11 billion and states paying nearly $4 billion of this estimated total.

The law requires Innovation Center models to either maintain or reduce program expenditures. The BALANCE Model is designed to test whether lower negotiated prices as applied to currently covered indications will lower program spending. It is unclear how the new negotiated prices under the model for state Medicaid programs (which remain confidential) compare to the net prices state Medicaid programs are currently paying for these drugs, but Medicaid already typically pays lower prices than other payers for prescription drugs. In general, without knowing what Medicaid and Medicare generally are currently paying for these drugs on net, it is uncertain whether the lower prices that will be made available to state Medicaid programs and Part D plans under the BALANCE Model for currently covered uses of GLP-1s will generate enough savings to offset the additional costs from expanded use of these medications for obesity. If state Medicaid programs estimate the costs from expanded use will outweigh the savings, initial state Medicaid participation may be limited, especially given recent state budget challenges and federal funding cuts. Based on the reluctance of major Part D plan sponsors to participate in the BALANCE Model in 2027 under the original specifications, it appears that sponsors had insufficient data to estimate their added costs associated with covering GLP-1s for obesity.

Evaluations of the model will also determine whether improvements in health related to the use of these drugs and associated reductions in health care utilization are significant enough to maintain or reduce health care costs in the Medicaid and Medicare programs, after taking into account expanded use and coverage of GLP-1s for the treatment of obesity. Even with lower prices, there is little evidence to date to suggest that the expanded use of GLP-1s will be offset by lower spending on other health care services in the short term, even though the drugs do provide significant health benefits to users.  

The cost of the Medicare GLP-1 Bridge is not discussed in CMS documentation about this demonstration. Federal spending is expected to increase under this demonstration due to paying for GLP-1s for obesity, which is not currently covered under Medicare, but the amount of the increase is unknown since CMS hasn’t disclosed the projected cost. In addition, because the demonstration will operate outside the Part D benefit, the manufacturers won’t be responsible for providing the manufacturer price discount on eligible GLP-1s (10% in the Part D initial benefit phase and 20% in the catastrophic phase.) While many prior section 402 demonstrations have had to conform to budget neutrality rules by the Office of Management and Budget (OMB), some demonstrations have been able to move forward without this requirement. Given the short timeframe of the GLP-1 demonstration, it is unlikely that there will be cost offsets from improved health due to increased GLP-1 use for obesity that can be documented.

While spending on prescription drugs accounts for a relatively small share of overall Medicaid spending, Medicaid drug spending has grown in recent years. As a result, both states and the federal government continue to prioritize the management of rising prescription drug costs. There have been several recent Trump administration prescription drug initiatives, including negotiating “most-favored-nation” (MFN) drug pricing deals. These MFN agreements are based on the premise that the U.S. shouldn’t pay higher prices for prescription drugs than other comparable nations. The deals include agreements by drug manufacturers to provide MFN pricing in Medicaid and other commitments in return for a 3-year reprieve from tariffs, though the specific details of these agreements remain confidential. Though prices vary across countries, studies have shown that drug prices in the U.S. are about three times higher than in other countries.

To make MFN drug prices available to state Medicaid programs, the Centers for Medicare & Medicaid Services (CMS) developed 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. Given significantly lower drug prices internationally, this approach could result in substantial Medicaid savings, with a recently released White House report estimating that a voluntary MFN framework in Medicaid would save $64.3 billion over a 10-year period. While initial savings would be large and diminish over time – in part due to the fact that prices in other countries might increase as a result – savings would average $6.43 billion a year, or approximately 14% of annual Medicaid prescription drug spending.

However, it is unclear what assumptions were made to develop the administration’s estimates, and there remain several uncertain factors that make it difficult to assess the overall impact the new model will have on Medicaid drug costs. This issue brief provides background on the GENEROUS model, examines the factors that will contribute to the model’s overall impact on Medicaid drug costs, and illustrates how savings will depend on model details that are confidential or uncertain at this time. Key takeaways include:

• The impact of the GENEROUS model on Medicaid prescription drug spending remains unclear due to several uncertain factors related to drug pricing and model participation.
• Existing Medicaid rebates already reduce overall Medicaid prescription drug spending substantially, likely limiting the impact of the GENEROUS model’s MFN supplemental rebate approach.
• GENEROUS model savings will depend on which manufacturers and states participate as well as what drugs are included in the model due to variation in drug rebates (and net prices) as well as spending and utilization trends.

What Is the GENEROUS Model?

The CMS Innovation Center launched the GENEROUS model in January 2026 with the goal of lowering Medicaid drug spending by offering prices based on what other countries pay. The model is voluntary for manufacturers, though it is expected that the seventeen pharmaceutical companies (e.g. Pfizer, AstraZeneca, etc.) that have signed MFN agreements will participate. Manufacturers now have until June 11, 2026 to apply to participate in the GENEROUS model (the deadline has been extended twice from March 31, 2026 to April 30, 2026 and again to June 11, 2026). The model is also voluntary for states, with states having until July 31, 2026 to submit their application and until August 31, 2026 to execute a state participation agreement with CMS. States may be able to join the model after August 31, 2026 at CMS discretion. The model will run for five years through 2030, though manufacturers and states may voluntarily terminate their participation and key terms between CMS and manufacturers may be renegotiated.

Through the GENEROUS model, CMS will negotiate supplemental drug rebates based on prices paid in other countries (or the “MFN price”). For model drugs (single source or innovator multiple source drugs, also known as brand drugs), CMS will calculate the MFN price based on international pricing data provided by manufacturers across eight other countries (the United Kingdom, France, Germany, Italy, Canada, Japan, Denmark, and Switzerland). The MFN price is the second lowest reported net price after any rebates or discounts and is adjusted by gross domestic product per capita using a purchasing power parity method. CMS will then calculate the supplemental rebate for each model drug that results in a Medicaid net price equivalent to the MFN price (more specifics on the MFN price and Medicaid guaranteed net unit price calculations are available in both the state request for applications (RFA) and the manufacturer RFA). States can select which model drugs they’d like to receive MFN pricing for and must enter into new supplemental rebate agreements (SRAs) that reflect the model’s key terms (states cannot receive additional supplemental rebates outside of the model for drugs they have opted into).

CMS and participating manufacturers will also negotiate uniform coverage criteria, which includes utilization controls such as prior authorization or step therapy. These terms will be based on existing criteria states have negotiated, and states will have to adopt the uniform criteria to access the supplemental rebate for a given drug. States currently negotiate their own SRAs with manufacturers and use an array of payment strategies and utilization controls to manage prescription drug expenditures. States often use placement on a preferred drug list (PDL) and prior authorization as leverage to negotiate supplemental rebates with manufacturers, though the specific strategies vary by state. The negotiation of standardized coverage criteria could help reduce the administrative burden for states and manufacturers of negotiating individual SRAs tied to specific clinical criteria. However, the negotiated criteria may be more broad or more restrictive than the criteria states have already developed, which could have implications for state participation and model savings.

CMS will also conduct GENEROUS model monitoring and evaluation. The law requires Innovation Center models to either maintain or reduce program expenditures, and the model will test whether the MFN supplemental rebate approach can reduce Medicaid drug costs. To the extent negotiated clinical criteria broadens, the model may also increase enrollee access. Throughout the model, CMS will track data and assess the impact of the model on health care spending and access to care as well as audit the manufacturer reported international drug pricing data. GENEROUS works within the existing Medicaid Drug Rebate Program (MDRP) framework and builds on other CMS supplemental rebate models including the Cell and Gene Therapy Access Model and the BALANCE model. Notably, while these models aim to address high drug costs for the Medicaid program, they do not affect out-of-pocket costs for Medicaid enrollees, which are limited to nominal amounts under federal law.

What Are the Potential Impacts on Medicaid Prescription Drug Spending?

The impact of the GENEROUS model on Medicaid prescription drug spending remains unclear due to several uncertain factors related to drug pricing and model participation. Several factors will affect model cost savings (Figure 1), many of which are confidential or not yet available, including:

• While data on gross drug prices is available, data on the size of rebates for specific drugs is proprietary in both Medicaid and internationally, making it difficult to compare net Medicaid prices to net international prices.
• At this time, it also remains uncertain which manufacturers and states will participate in the model and how long participation will last.
• Further, while model documentation makes it clear that states may select model drugs, it remains uncertain whether all drugs in a participating manufacturer’s portfolio will be subject to the model. The RFAs note that “model drugs are limited to all the single source drugs or innovator multiple source drugs of a participating manufacturer”, indicating manufacturers must include all of their covered outpatient drugs. However, the RFAs also report that the listed terms may differ from the final terms, and a CMS presentation to states noted “manufacturers will opt into the model for certain branded Medicaid covered outpatient drugs”, leaving it uncertain whether all of a manufacturer’s drugs will be subject to MFN pricing or if exemptions will be available. Recent letters from the Senate Finance Committee sent to drug manufacturers push for more model details, including which drugs will be included in the model.
• Lastly, details on the uniform coverage criteria for model drugs have not been released, making it difficult to assess the impact the terms may have on drug spending or access.

Existing Medicaid rebates already reduce overall Medicaid drug spending substantially, likely limiting the impact of the GENEROUS model’s MFN supplemental rebate approach. Medicaid programs already pay lower prices, net of rebates, than other payers due to the MDRP, which requires manufacturers to rebate a portion of drug payments to states. Medicaid rebates overall reduced gross Medicaid spending on prescription drugs by 53% on average from FY 2019 to FY 2024 (Figure 2). Rebates for brand drugs are typically even higher, with a Medicaid and CHIP Payment and Access Commission (MACPAC) analysis of FY 2020 data finding a 62% rebate overall for brand drugs.

At the same time, a recent study showed that U.S. drug prices overall were 2.78 times international drug prices (across 33 OECD countries); this differential is similar to those found in other research. Assuming U.S. drug prices are 2.78 times more than international prices, this would mean international prices are about one-third (36%) of U.S. drug prices. Based on this calculation, an MFN approach that reduced prices to international levels would provide a 64% rebate off existing U.S drug prices (Figure 2). The same study found U.S. brand drug prices were 4.22 times international drug prices, which is effectively a 76% rebate. While this is an illustrative example based on non-Medicaid specific drug prices in aggregate, it indicates that an MFN approach could provide substantial discounts given the large difference between drug prices in the U.S. and abroad. However, Medicaid already receives sizeable rebates, signaling there may be limits to this approach when applied to the Medicaid program.

However, rebates and net prices vary substantially by drug, meaning GENEROUS model savings will vary for each model drug (Figure 3). While data on the total rebate for a specific drug is confidential, rebates vary substantially by drug. The minimum federal statutory rebate for a brand drug is 23.1%, but FY 2020 data shows statutory rebates for brand drugs subject to Medicaid’s best price provision and inflationary rebate component are generally much higher, reaching 77% overall. Further, as of January 1, 2024, there is no longer a cap on the total rebate amount if a drug’s price increases quickly over time, meaning overall rebates may now be even higher. In addition to these federal statutory rebates, states have been increasingly negotiating supplemental rebates with manufacturers, with supplemental rebates across states reducing gross Medicaid spending by 7% in FY 2024 (resulting in a higher total rebate estimate of 84% if added to the 77% in statutory rebates for some brand drugs). International countries in the model may also negotiate rebates or discounts. Available studies indicate rebates vary by type of drug and country, ranging anywhere from 0% of gross spending in Japan to about 25% or more in several model countries including Canada, Germany, France, Switzerland.

To illustrate, this analysis examines three example drugs (Drugs A-C), all with a gross Medicaid price of $422 compared with $100 internationally (based on the above study) but with different sized rebates (Figure 3). Some drugs, typically newer drugs with few (or no) competitors in their therapeutic class, may have smaller rebates and large gaps between the net Medicaid and net international price (like Drug A). For example, Biktarvy, the first single tablet combination HIV treatment with the ingredient bictegravir, was FDA approved in 2018 and had an estimated Medicaid rebate of 24% in 2019. It can be difficult for states to secure supplemental rebate agreements for these types of drugs, meaning their inclusion in the model would likely result in savings for states but at a cost to manufacturers.

However, there are also drugs, typically those with more competitors or that have been on the market longer, for which states are already receiving sizeable Medicaid rebates (like Drug B or C). For example, Eliquis, an anticoagulant (or blood thinner), was FDA approved in 2012 and had an estimated Medicaid rebate of 100% in 2019, meaning Medicaid programs are likely paying little to nothing for the drug. In cases where Medicaid rebates are already high, there may not be substantial savings for states through the GENEROUS model, but the impact of the model on manufacturer profits would be mitigated.

Medicaid drug rebates also vary by state, resulting in differing model impacts across states. While federal statutory rebates are required by law and calculated by CMS, the number and magnitude of SRAs vary across states. Medicaid rebates reduced gross Medicaid spending on prescription drugs by 53% on average nationally from FY 2019 to FY 2024, though the percentage varies across states. MACPAC data from FY 2024 shows that drug rebates (including both statutory and state supplemental rebates) reduced gross Medicaid spending on drugs by less than 40% in four states (Kentucky, Oregon, South Dakota, and Virginia) to over 90% in another four states (Delaware, Mississippi, Nevada, and Wyoming). This variation likely reflects differences in the amount and types of drugs paid for as well as differences in SRAs across states. States will likely complete their own internal analyses to assess model impact, including comparing their existing supplemental rebate agreements to what is available under the model and analyzing the impacts of standardized criteria before entering into new model SRAs.

Medicaid drug utilization and spending patterns will also have implications for the Medicaid savings possible under the model. KFF analysis of Medicaid State Drug Utilization Data shows that a relatively small number of drugs account for a large share of Medicaid drug spending (Figure 4). The top five drugs (Biktarvy, Humira, Stelara, Dupixent, and Ozempic) account for 10% of all Medicaid drug spending, and the top 50 drugs account for over one-third of all Medicaid drug spending. Substantial MFN supplemental rebates on the costliest and most utilized drugs for Medicaid programs could result in significant savings (if the drugs are not already subject to sizeable Medicaid rebates), whereas substantial rebates on drugs that are not frequently utilized or only account for a small share of spending would have less of an impact. In addition, the overall number of participating manufacturers and model drugs as well as the number of participating states will affect the magnitude of savings.

Overall, GENEROUS model savings will depend on who participates, both manufacturers and states, and what drugs are included. While these factors remain uncertain at this time, the implications for Medicaid drug costs may become clearer as additional model details become available or if manufacturers respond to recent Senate letters requesting details of the Trump administration’s deals. Looking ahead, substantial state participation will likely indicate the potential for considerable model savings as states may only opt in if they expect the model supplemental rebates to be larger than their current supplemental rebates. States are also currently facing broader state budget pressures and federal Medicaid cuts, which may make some states eager to adopt pharmacy cost containment strategies. Further, manufacturer model participation may increase following the recent announcement of new pharmaceutical tariffs for companies who have not yet entered into MFN deals, though it is not clear what will happen to manufacturer participation when the tariff reprieves end. Once implemented, the GENEROUS model could also have implications for Medicaid prices on drugs from non-participating manufacturers or for the broader drug market, including changes in international prices or manufacturer participation in international markets.

Medication abortion—most commonly a two-drug regimen of mifepristone and misoprostol—has become a central legal battleground in the years since Dobbs v. Jackson Women’s Health Organization. Over 25 years ago, the U.S. Food and Drug Administration (FDA) approved mifepristone, along with a requirement that the drug be dispensed in person by a physician. In 2023, after reviewing research that continued to demonstrate its safety even when dispensed through telehealth, the FDA eliminated the requirement that the drug be dispensed in person, enabling the drug to be mailed or dispensed by retail pharmacies. This change has allowed clinicians to dispense the drug via mail and enabled tens of thousands of patients to access medication abortion in states where the provision of abortion is outlawed.

Multiple lawsuits filed after 2022 have focused specifically on the FDA’s role in regulating mifepristone: whether the agency can set conditions of use through its Risk Evaluation and Mitigation Strategy (REMS), whether courts can override the agency’s scientific and administrative judgments, and how state abortion bans interact with federal drug regulation. In 2024, the Supreme Court ruled in Alliance for Hippocratic Medicine v. FDA, that a group of doctors, associations and organizations that oppose abortion lacked legal standing to challenge the FDA’s approval of mifepristone, but did not reach the merits of their claims.

Three state-led lawsuits are now claiming that FDA policy enabling remote prescribing and mailing of mifepristone harms states by undermining their abortion restrictions and generating downstream costs. Several provider- and organization-led cases argue the opposite: that FDA restrictions – which allow mifepristone to be mailed, but only through certified prescribers and pharmacies — remain unlawfully burdensome given the drug’s safety record. This brief reviews the case now before the Supreme Court, Louisiana v. FDA, provides an overview of the other pending litigation involving mifepristone, and the mounting tension between states seeking to protect abortion and states banning the provision of abortion.

Overview of the Case

In October 2025, Louisiana filed a lawsuit against the FDA claiming the agency violated the Administrative Procedure Act (APA) when it approved the 2023 REMS for mifepristone. Louisiana also claims that the 2023 REMS violates an 1873 anti-obscenity law, the Comstock Act, which prohibits the mailing of any medication used for abortion. The 2023 REMS no longer required that the drug be dispensed in person to patients and enabled the medication to be mailed or dispensed at retail pharmacies like most prescription drugs. The state of Louisiana alleges that this revised dispensing requirement has harmed the state and interferes with their ability to regulate abortion in their own state (Louisiana bans the provision of abortions). The Trump Administration defended the FDA and said that an internal review was already underway to examine the 2023 approval decision and the medication’s safety record in light of the updated dispensing policies. In April 2026, the U.S. District Court for the Western District of Louisiana paused the litigation for six months to give the FDA time to continue its review of the drug’s safety. Louisiana appealed this decision to the 5th Circuit Court of Appeals.

On May 1, 2026, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit granted Louisiana’s request to roll back the FDA rules that enabled remote prescribing, mailing and retail pharmacy dispensing while the appeal proceeds. This decision, which required mifepristone to be dispensed only in person, took effect immediately with implications for abortion access nationwide, not just in states where abortion is banned. That evening Danco Laboratories, one of the drug manufacturers and an intervenor-defendant, filed an emergency motion asking the Fifth Circuit to pause its decision for one week to allow them time to appeal to the U.S. Supreme Court. The following day, after the Fifth Circuit did not respond to Danco’s motion, Danco and GenBioPro (another mifepristone manufacturer) filed emergency appeals to the Supreme Court. Justice Alito granted a one-week administrative stay of the Fifth Circuit’s decision.

On appeal the Supreme Court will first consider whether the Plaintiffs have legal standing to bring this case; without legal standing, the case does not proceed. Both the district court and the Fifth Circuit Court of Appeals found Louisiana has legal standing because it has shown injury caused by the FDA’s 2023 REMS that can be alleviated by a court decision. However, in a similar case, Alliance for Hippocratic Medicine v. FDA, the Supreme Court ruled that a group of doctors and health providers did not have standing for multiple reasons including that they could not show a concrete injury resulting from the updated FDA mifepristone dispensing requirements.

In this lawsuit Louisiana asserts that the policy of allowing mifepristone to be mailed has harmed the state’s ability to enforce its abortion ban and has caused the state to spend state Medicaid funds on patients who took mifepristone received by mail and then needed emergency care for complications. Specifically, “Louisiana identifies $92,000 it paid in Medicaid costs from two women who needed emergency care in 2025 from complications caused by out-of-state mifepristone.” 

The FDA, and the drug manufacturers (GenBioPro and Danco), claim that Louisiana has failed to show legal standing. The FDA regulates drugs and has no oversight over states or providers. They assert that the FDA’s 2023 REMS does not implicate the State’s sovereign “power to create and enforce a legal code.” The Defendants further argue that Louisiana’s alleged Medicaid-based economic harm is too “attenuated” to establish standing, suggesting Louisiana cannot show that the FDA’s policy of allowing mifepristone to be mailed led to their alleged economic harm. Patients could obtain mifepristone out of state, bring it back to Louisiana, and suffer the same complications, they argue.

The Defendants (the FDA, Danco and GenBioPro) assert that if Louisiana is granted standing in this case, a state could challenge any federal policy alleged to have caused a visit to a doctor or a hospital for which the state pays the bills. The Defendants cite to the examples the Supreme Court provided in the decision denying the Alliance for Hippocratic Medicine standing: “EPA roll[ing] back emissions standards for power plants,” “[a] federal agency increas[ing] a speed limit from 65 to 80 miles per hour,” and the federal government “repeal[ing] certain restrictions on guns.”

The FDA’s Tightrope Walk—Defending Agency Authority While Not Defending the 2023 REMS

The FDA’s posture in this case and the related litigation has been complicated by the transition from the Biden administration, which embraced reproductive rights, to the Trump administration, which supports abortion restrictions. The agency is defending the lawsuits. But, after pressure from anti-abortion organizations and state attorneys general, in September 2025, the FDA announced it was conducting a comprehensive review of mifepristone, including the 2023 REMS. When announcing the review, the FDA wrote, “HHS’s decision to do so is informed by the lack of adequate consideration underlying the prior REMS approvals, and by recent studies raising concerns about the safety of mifepristone as currently administered.” The Fifth Circuit relied on that statement in its ruling, finding that the FDA conceded in the September 2025 letter that it did not comply with the Administrative Procedures Act when removing the in-person dispensing requirement.

The Trump administrations FDA position contrasts with the administrative record underlying the FDA’s 2023 REMS decision, which shows the FDA’s removal of the in-person dispensing requirements was grounded in more than two decades of experience with mifepristone. The 2023 analysis included: its 2021 review of published literature; safety information submitted during the COVID-19 pandemic; more than five years of adverse data; a separate one-year assessment report for the REMS; and information provided by advocacy groups, individuals and manufacturers. The FDA found that all this information supported the safety of the REMS modification in 2023. The FDA further found there were “no new safety concerns” related to the removal of the in-person dispensing requirement. It therefore concluded that, “[r]emoving the in-person dispensing requirement will render the REMS less burdensome to healthcare providers and patients and provided all other requirements of the REMS are met, including the additional requirement for pharmacy certification, the REMS will continue to ensure that the benefits of mifepristone for medical abortion outweigh the risks.”

Enforcement of a Court Decision Directed at the FDA

A court order to rescind the 2023 REMs would again require in person dispensing, resulting in regulatory pressure on Mifepristone manufacturers (Danco, GenBioPro and Evita Solutions) to ensure that providers certified to dispense mifepristone comply with a court order, and only dispense the medication in person. Furthermore, it is unprecedented for a federal court to compel the FDA to modify the REMS for an approved medication and could potentially undermine the agency’s authority to determine and regulate drug safety.

Even if the Court suspends the FDA’s policy of dispensing mifepristone by mail, that will not end the use of telehealth in the provision of medication abortions. Some clinics and providers will respond by switching to a misoprostol-only regimen. While this single drug regimen is less effective (approximately 80-100% depending on the regimen and pregnancy duration) than using the highly effective mifepristone and misoprostol regimen (between 91.9 to 99.7% depending upon the gestational duration and route or interval of misoprostol administration) it is still a demonstrated protocol that is used in many countries. While misoprostol alone is effective, it can also cause abortion patients to experience more side effects, including greater pain, bleeding, and gastrointestinal effects than the regimen with mifepristone and misoprostol combined.

Conflict Between States

Interstate Conflict and the Rise of Shield Laws

Many states that are protective of abortion rights have implemented so-called “shield laws.” These laws are designed to protect telehealth providers prescribing and mailing mifepristone in their state from criminalization across state lines. As GenBioPro and Danco highlight in their appeals to the Supreme Court: “Louisiana’s filings below made clear—the alleged frustration of Louisiana’s laws occurs because other “states have enacted ‘shield laws’ to protect medical practitioners in their states from extradition for prescribing” mifepristone. This difference in state policies is yet again a natural result of this Court “return[ing]” abortion policy to the states,” in the Dobbs ruling.

Under shield laws, in June 2025 approximately 55% of telehealth medication abortions were provided to people living in states with abortion bans or telemedicine bans according to the #WeCount project of the Society of Family Planning. That month, 45% of telehealth medication abortions were mailed to patients in states without restrictions reflecting the uneven availability of abortion even in states where abortion is not restricted. Texas and Louisiana have attempted to prosecute or fine telehealth providers in California and New York but have been blocked by shield laws.

New State Laws Regulating Mifepristone

Beyond regulating abortion generally, states have implemented new laws specifically targeting medication abortion. These laws often prohibit the prescription, dispensing, or mailing of abortion-inducing drugs within state borders, and in some instances impose criminal penalties on providers. Such measures operate in direct tension with the FDA’s policy set forth in the REMS for mifepristone. For example, Mississippi recently passed a new law (effective July 1, 2026) that makes it unlawful to manufacture, distribute, dispense or prescribe abortion medication. Anyone who violates the law may face civil liability and up to 10 years in prison. Louisiana has enacted a law that classifies mifepristone and misoprostol as controlled substances, which limits the appropriate storage and dispensing; however, this law is currently being challenged in state court. Texas also passed a new law that allows private citizens to sue individuals or entities that provide, mail, or transport abortion medication to or from Texas.

Proposed Federal Bills and Investigations

Dissatisfied with the pace of the FDA review, Senator Josh Hawley, an anti-abortion leader, has introduced a bill that would rescind the FDA’s approval of mifepristone. He has also launched an investigation into mifepristone manufacturers Danco Laboratories and GenBioPro seeking information about adverse events associated with the drug, claiming that the drug is risky based on the results of the same study cited by HHS officials. In April 2026, Indiana Senator Jim Banks sent a letter to the Federal Trade Commission Chairman urging the Commission to investigate abortion drug manufacturers for allegedly engaging in deceptive trade practices and promoting misleading safety claims.

Other Cases Involving the FDA and Medication Abortion

In recent years, courts have issued conflicting rulings on the FDA’s 2023 decision to eliminate the in-person dispensing requirement. (Table 1) In July 2025, a federal court in Washington upheld the REMS revisions, while in October 2025, a federal court in Hawaii (Purcell v. Kennedy) ruled that the FDA violated the Administrative Procedure Act, “by failing to provide a reasoned explanation for its restrictive treatment of the drug ”when it maintained restrictions on access to mifepristone in 2023. The court has ordered the FDA to review evidence it allegedly overlooked including, “the wealth of peer-reviewed evidence proving mifepristone’s safety, including when delivered by telemedicine as well as how FDA’s restrictions burden patient access.”

Additional lawsuits underway brought by states, Missouri, Idaho, Kansas, Florida, and Texas, also challenge either the FDA’s original approval or subsequent modifications to the REMS. Florida and Texas have agreed to pause their litigation while the FDA continues its internal review.

Whole Woman’s Health Alliance, an independent abortion provider in Virginia with other independent abortion providers in Montana and Kansas, filed a lawsuit (Whole Woman’s Health Alliance v. FDA) against the FDA in May 2023, asserting that the FDA violated the Administrative Procedure Act when imposing REMS on mifepristone. The lawsuit seeks to remove all the REMS for mifepristone. This case is ongoing, and the Plaintiffs have opposed a stay to allow the FDA to continue its internal review.

Separate litigation is also testing whether the FDA’s regulation of mifepristone preempts state restrictions. In GenBioPro v. Raynes (West Virginia), GenBioPro challenged the state’s near-total abortion ban; in July 2025, the Fourth Circuit affirmed dismissal of the case, holding that the FDA’s mifepristone policies do not preempt West Virginia’s ban. In a second case, brough in North Carolina, Bryant v. Stein(formerly Bryant v. Moore), a physician argues that the FDA’s dispensing framework for mifepristone preempts additional state-law restrictions—on the theory that the FDA considered more stringent limits on mifepristone and chose not to adopt them, so states may not impose those same restrictions. There is a Louisiana state court challenge brought by Birthmark Doula Collective to Louisiana’s law which classifies mifepristone and misoprostol as controlled substances, subjecting these medications to controlled-substance storage, prescribing and dispensing rules. This case tests whether a state can use controlled-substance classification to restrict access to medication.

Looking Ahead

The return of mifepristone to the Supreme Court underscores how many questions remain post-Dobbs about how state authority to regulate abortion intersects with federal authority to regulate drugs. In Louisiana v. FDA, the immediate question before the Court is whether Louisiana has legal standing to challenge FDA’s 2023 REMS. Justice Alito issued an administrative stay of the Fifth Circuit’s decision until May 11, 2026. How the Supreme Court handles the emergency appeal once that stay expires will determine whether the rollback of the 2023 REMS remains in effect while the case proceeds and will signal how the Supreme Court views deference to the FDA on matters of drug approval and safety.

While the Supreme Court considers this case, related lawsuits are pulling in opposite directions—other state-led challenges also seeking to restore the in-person dispensing requirement for mifepristone, provider-led cases arguing the current REMS are unlawfully burdensome, and preemption cases testing whether states can restrict an FDA-approved drug. At the same time, state shield laws offer protections to providers who prescribe and mail medication abortion to patients in states with abortion bans, intensifying interstate conflict and raising new questions about enforcement and jurisdiction.