The FDA recently approved a new use for Wegovy (semaglutide), the blockbuster anti-obesity drug, to reduce the risk of heart attacks and stroke in people with cardiovascular disease who are overweight or obese. Wegovy belongs to a class of medications called GLP-1 (glucagon-like peptide-1) agonists that were initially approved to treat type 2 diabetes but are also highly effective anti-obesity drugs. The new FDA-approved indication for Wegovy paves the way for Medicare coverage of this drug and broader coverage by other insurers. Medicare is currently prohibited by law from covering Wegovy and other medications when used specifically for obesity. However, semaglutide is covered by Medicare as a treatment for diabetes, branded as Ozempic.

What does the FDA’s decision mean for Medicare coverage of Wegovy?

The FDA’s decision opens the door to Medicare coverage of Wegovy, which was first approved by the FDA as an anti-obesity medication. Soon after the FDA’s approval of the new use for Wegovy, the Centers for Medicare & Medicaid Services (CMS) issued a memo indicating that Medicare Part D plans can add Wegovy to their formularies now that it has a medically-accepted indication that is not specifically excluded from Medicare coverage. Because Wegovy is a self-administered injectable drug, coverage will be provided under Part D, Medicare’s outpatient drug benefit offered by private stand-alone drug plans and Medicare Advantage plans, not Part B, which covers physician-administered drugs.

How many Medicare beneficiaries could be eligible for coverage of Wegovy for its new use?

The new use of Wegovy is targeted to people with established cardiovascular disease – meaning a prior heart attack, prior stroke, or peripheral arterial disease – and either obesity or overweight. Based on KFF analysis of Medicare data from 2020, an estimated 7% of Medicare beneficiaries, or 3.6 million overall, had established cardiovascular disease and obesity or overweight in 2020, and so could be eligible for Medicare coverage of Wegovy for its new indication (Figure 1) (see Methods for details). This number may well be higher based on more current data than were available for this analysis. These 3.6 million beneficiaries represent just over a quarter (26%) of the 13.7 million Medicare beneficiaries diagnosed as being overweight or obese in 2020. This means that the FDA’s approval of the new use for Wegovy potentially opens up access to this drug for 1 in 4 people on Medicare with obesity or overweight.

Of these 3.6 million beneficiaries, 1.9 million also had diabetes (other than Type 1) and may already have been eligible for Medicare coverage of GLP-1s as diabetes treatments prior to the FDA’s approval of the new use of Wegovy.

Not all people who are eligible based on the new indication are likely to take Wegovy, however. Some might be dissuaded by the potential side effects and adverse reactions. Out-of-pocket costs could also be a barrier. Based on the list price of $1,300 per month (not including rebates or other discounts negotiated by pharmacy benefit managers), Wegovy could be covered as a specialty tier drug, where Part D plans are allowed to charge coinsurance of 25% to 33%. Because coinsurance amounts are pegged to the list price, Medicare beneficiaries required to pay coinsurance could face monthly costs of $325 to $430 before they reach the new cap on annual out-of-pocket drug spending established by the Inflation Reduction Act – around $3,300 in 2024, based on brand drugs only, and $2,000 in 2025. But even paying $2,000 out of pocket would still be beyond the reach of many people with Medicare who live on modest incomes. Ultimately, how much beneficiaries pay out of pocket will depend on Part D plan coverage and formulary tier placement of Wegovy.

Further, some people may have difficulty accessing Wegovy if Part D plans apply prior authorization and step therapy tools to manage costs and ensure appropriate use. These factors could have a dampening effect on use by Medicare beneficiaries, even among the target population.

When will Medicare Part D plans begin covering Wegovy?

Some Part D plans have already announced that they will begin covering Wegovy this year, although it is not yet clear how widespread coverage will be in 2024. While Medicare drug plans can add new drugs to their formularies during the year to reflect new approvals and expanded indications, plans are not required to cover every new drug that comes to market. Part D plans are required to cover at least two drugs in each category or class and all or substantially all drugs in six protected classes. However, facing a relatively high price and potentially large patient population for Wegovy, many Part D plans might be reluctant to expand coverage now, since they can’t adjust their premiums mid-year to account for higher costs associated with use of this drug. So, broader coverage in 2025 could be more likely.

How might expanded coverage of Wegovy affect Medicare spending?

The impact on Medicare spending associated with expanded coverage of Wegovy will depend in part on how many Part D plans add coverage for it and the extent to which plans apply restrictions on use like prior authorization; how many people who qualify to take the drug use it; and negotiated prices paid by plans. For example, if plans receive a 50% rebate on the list price of $1,300 per month (or $15,600 per year), that could mean annual net costs per person around $7,800. If 10% of the target population (an estimated 360,000 people) uses Wegovy for a full year, that would amount to additional net Medicare Part D spending of $2.8 billion for one year for this one drug alone.

It’s possible that Medicare could select semaglutide for drug price negotiation as early as 2025, based on the earliest FDA approval of Ozempic in late 2017. For small-molecule drugs like semaglutide, at least seven years must have passed from its FDA approval date to be eligible for selection, and for drugs with multiple FDA approvals, CMS will use the earliest approval date to make this determination. If semaglutide is selected for negotiation next year, a negotiated price would be available beginning in 2027. This could help to lower Medicare and out-of-pocket spending on semaglutide products, including Wegovy as well as Ozempic and Rybelsus, the oral formulation approved for type 2 diabetes. As of 2022, gross Medicare spending on Ozempic alone placed it sixth among the 10 top-selling drugs in Medicare Part D, with annual gross spending of $4.6 billion, based on KFF analysis. This estimate does not include rebates, which Medicare’s actuaries estimated to be 31.5% overall in 2022 but could be as high as 69% for Ozempic, according to one estimate.

What does this mean for Medicare coverage of anti-obesity drugs?

For now, use of GLP-1s specifically for obesity continues to be excluded from Medicare coverage by law. But the FDA’s decision signals a turning point for broader Medicare coverage of GLP-1s since Wegovy can now be used to reduce the risk of heart attack and stroke by people with cardiovascular disease and obesity or overweight, and not only as an anti-obesity drug. And more pathways to Medicare coverage could open up if these drugs gain FDA approval for other uses. For example, Eli Lilly has just reported clinical trial results showing the benefits of its GLP-1, Zepbound (tirzepatide), in reducing the occurrence of sleep apnea events among people with obesity or overweight. Lilly reportedly plans to seek FDA approval for this use and if approved, the drug would be the first pharmaceutical treatment on the market for sleep apnea.

If more Medicare beneficiaries with obesity or overweight gain access to GLP-1s based on other approved uses for these medications, that could reduce the cost of proposed legislation to lift the statutory prohibition on Medicare coverage of anti-obesity drugs. This is because the Congressional Budget Office (CBO), Congress’s official scorekeeper for proposed legislation, would incorporate the cost of coverage for these other uses into its baseline estimates for Medicare spending, which means that the incremental cost of changing the law to allow Medicare coverage for anti-obesity drugs would be lower than it would be without FDA’s approval of these drugs for other uses. Ultimately how widely Medicare Part D coverage of GLP-1s expands could have far-reaching effects on people with obesity and on Medicare spending.

In light of worsening mental health among youth, strategies have been implemented to improve access to behavioral health services in recent years, including expanding school-based care for students. School-based behavioral health services can improve access to care and allow for early identification and treatment of mental health issues. However, challenges such as funding and workforce shortages often hinder implementation and sustainability of these services. Further, although 96% of public schools offered at least some mental health services in the 2021-2022 school year, only 12% strongly agreed that they could effectively provide mental health services to all students in need.

Leveraging Medicaid to improve and address gaps in school-based behavioral health services has been a key strategy in recent years as youth mental health concerns have grown. Medicaid provides significant financing for the delivery of these school services and provides coverage to approximately 4 in 10 children nationwide. School-based behavioral health programs may rely on Medicaid in several ways, including reimbursement for medically necessary services that are part of a student with a disability’s Individualized Education Plan (IEP), for eligible health services for students with Medicaid coverage, and for some administrative activities. Recent guidance states that Medicaid spending for school-based health services in 2021 was nearly $6 billion. Provisions from the Safer Communities Act of 2022 utilize Medicaid to expand both school-based health care and other mechanisms of youth behavioral health care in several ways, including:

• Requiring the Centers for Medicare and Medicaid Services (CMS) to provide states with guidance on how to support and expand school-based health care, including mental health services.
• Awarding $50 million in planning grants to states to create and/or build out school-based health services.
• Improving the implementation of Medicaid’s Early and Periodic Screening, Diagnostic and Treatment benefit across states.

This issue brief explores the implementation of these provisions from the Safer Communities Act thus far, with a focus on the guidance issued from CMS. While the guidance is complex and covers a wide array of services, this analysis focuses on provisions related to behavioral health services (i.e. services for mental health and substance use disorders). This guidance is the first updated Medicaid guidance on school-based services in nearly 20 years and provides detailed information on ways to make payments for school-based services and reduce administrative burden. Additionally, this brief highlights other, recent federal initiatives that may impact youth behavioral health care access in schools.

How does the recent guidance from CMS address access to behavioral health care in schools?

CMS issued new guidance on school-based health services in 2022 and 2023; this updated guidance highlights the importance of providing behavioral health services to students. The goal of the updated guidance is to increase access to school-based health services and to decrease the administrative burden schools face when delivering services through Medicaid. The guidance provides an overview of services that can be offered in schools and how those services can be delivered; outlines flexibilities in billing, documentation, and claiming practices; and updates provider qualification requirements. Medicaid may cover a range of health services provided to children in schools including health screening services, speech or physical therapy for children with disabilities, and a range of medically necessary physical, mental health, and SUD services. Specific behavioral health services including psychological testing and evaluation, individual and group therapy, and behavioral health crisis services. The guidance does not expand upon services covered but clarifies what is covered and how schools can most efficiently deliver them under Medicaid. The guidance encourages state Medicaid agencies to coordinate with state education agencies and schools to facilitate school-based services and announces opportunities for technical assistance. Finally, the guidance explicitly states the advantages of providing behavioral health services in schools, noting that school-based behavioral health services are linked to improved access to mental health treatment, fewer disciplinary actions, and higher graduation rates among students.

The guidance aims to facilitate increased school provider capacity through 1) opportunities for higher reimbursement rates and 2) broadening the provider qualification requirements. Historically, reimbursement rates for school-based services could not exceed rates for the same services offered in a community setting. However, the updated guidance highlights opportunities in which the reimbursement for school-based services may be higher than the community reimbursement rate due to additional costs associated with operating in a school environment. Rates would be at the regular Medicaid match rate and must still be consistent with Medicaid rules that require payments to be consistent with efficiency, economy, and quality of care. The ability to pay school-based providers higher rates may be a strategy for schools to build out and/or retain providers, as seen in South Carolina in 2022. Additionally, the guidance says that states have the flexibility to determine which providers of school-based services will be covered and to establish minimum provider qualifications that may differ from qualifications for non-school based services. The guidance provides the example that states provide counseling services by school social workers who may not be able to provide such services outside of a school setting because they lack the required credentials. These changes aim to mitigate widespread behavioral health provider shortages for youth.

With the intention of reducing administrative burden, the updated guidance offers simplified methods and clarifications­ on billing and claiming processes. Medicaid claiming and payment practices pose an administrative burden on schools and may impact their ability to provide and sustain health services (including for behavioral health) for students. For example, the Reconciled Cost Methodology is a common route of reimbursement; however, it requires multiple steps including careful documentation of covered services provided to Medicaid-enrolled students and determining interim payments throughout the year to allow for appropriate cash flow. The updated guidance offers detailed information for each step and provides examples for states to take into consideration. Random Moment Time Studies – a method used to determine the amount of time schools spend on Medicaid-covered services and administrative activities – are also time consuming, complex, and require detailed documentation. The updated guidance eases this process in several ways, including greatly reducing the number of times these studies must be completed by staff.

The guidance specifies coverage of interprofessional consultants and the ability to expand access to 988. Interprofessional consultations expand access to specialty care and foster interdisciplinary input on patient care. In the context of schools, a school-based provider could consult with a specialty provider about a student’s needs and bill the consulting provider’s time to Medicaid. In the past, consulting providers were not covered by Medicaid since the patient would not be present. In addition, the guidance specifies that state Medicaid agencies and schools can partner to expand the use of 988 for students experiencing suicidal ideation, issues with substance use, and/or mental health crisis, or any other kind of emotional distress.

The guidance highlights opportunities to use CHIP behavioral health benefits, including Health Services Initiatives to address mental health and substance use. CHIP behavioral health benefits include screenings, preventive services, therapy, and treatments such as medication-assisted treatment for opioid use disorders and tobacco cessation services. Health Services Initiatives (HSIs) allow states to use a portion of CHIP funds to improve the health of low-income children, including their mental health. HSIs can include coverage of direct care or broader public health measures. For example, New York currently has an HSI for providing and training school staff with naloxone kits to prevent overdose-related deaths for students. Nevada previously had an HSI covering mental health services in after-school programs for high-risk students.

As indicated in the guidance, CMS, in partnership with the Department of Education, launched a Technical Assistance Center for school-based Medicaid services. The intention of the center is to help schools – particularly schools in rural areas – and state Medicaid programs implement and expand school-based services in a variety of ways, including navigating complex Medicaid billing practices. The center has so far hosted webinars covering topics such as service implementation and evaluation processes, developing payment methodologies, and recommendations for engaging local education agencies. The center recently published FAQs that offer information on topics such as requirements for submitting state plan amendments and billing.

In 2024, CMS opened applications for state-level grants totaling $50 million to be used toward expanding school-based services. CMS anticipates that 20 states will receive $2.5 million over three years from the grant funding. At least 10 of the awarded grants will be marked for states that currently do not cover school-based services for all children enrolled in Medicaid. CMS anticipates that funds will be awarded by this summer. The $2.5 million of funds is modest but provides a mechanism for states to obtain additional administrative resources that will lead to greater access and coverage of school-based services.

Even with the implementation of Medicaid-related provisions from the Safer Communities Act, some barriers to expanding Medicaid school-based services remain. For example, there is no mechanism in place for schools to easily identify which students are eligible for services (i.e., which students are enrolled in Medicaid).

What other recent measures leverage Medicaid for behavioral health care access among children?

CMS guidance from 2022 summarizes existing resources and provides examples of ways to leverage funding and expand access to mental health and substance use disorder (SUD) services through the Early Periodic Screening Diagnosis and Treatment (EPSDT) benefit and how this extends to school-based services. This Center for Medicaid and CHIP Services (CMCS) Informational Bulletin also provides State Medicaid Agencies, agencies administering the Children’s Health Insurance Program (CHIP), state behavioral health agencies, state developmental disability agencies, and other stakeholders with relevant existing federal guidance and examples on ways that Medicaid and CHIP funding, alone or in tandem with funding from other federal programs of the Department of Health and Human Services (HHS), can be used in the provision of high-quality behavioral health services to children and youth. CMCS remains committed to providing information and technical assistance on leveraging funding opportunities to optimize beneficiary access to needed.

The guidance provides various strategies to expand and strengthen behavioral health services for children with Medicaid. Under EPSDT, states may cover services even for students who do not have an existing mental health/SUD diagnosis. EPSDT extends to prevention, screening, assessment, and treatment for behavioral health conditions without fixed limits on coverage. The 2022 guidance cites examples of state efforts to increase behavioral health screenings and school-based services; for example, in Arizona, Michigan, and Georgia. The Bipartisan Safer Communities Act requires federal agencies to review EPSDT implementation and provide updated guidance for state Medicaid programs by June 2024 and requires review and updated guidance every five years thereafter.

In 2024, CMS released new guidance on how state Medicaid agencies can further adopt broad telehealth coverage to improve access to care in schools. CMS highlighted three states as examples of best practices for delivering Medicaid school-based health services, including behavioral health services.

• Colorado‘s website with information on billing for school-based services includes procedure codes for telehealth services, including tele-behavioral health services.
• New Mexico provides a list of facilities that can serve as an originating site for a telehealth visit, including school-based health centers.
• Washington offers a School-Based Health Care Services Program Billing Guide that includes information on which originating sites are covered for telehealth services for students with disabilities. Information for providers billing services for students without disabilities can be found in the states’ Telemedicine Policy and Billing Guide.

Outside of Medicaid, other provisions from the Safer Communities Act address access to children’s behavioral health services. Provisions include providing trauma care to students, expanding the number of school-based mental health providers, and funding additional school programming. SAMHSA has awarded $74 million to Project AWARE, a program to develop mental health support and trauma care in schools. As of February 2024, the Department of Education distributed more than $571 million to increase the training and hiring of school-based mental health professionals. The Biden Administration’s proposed budget for FY 2025 includes $200 million from the Safer Communities Act to increase the number of mental health professionals in schools. President Biden’s proposed budget also adds $19 million to the CDC’s Leadership Exchange for Adolescent Health Promotion initiative, which develops plans for school-based services focused on behavioral health.

Based on a new KFF analysis, fewer than 1 in 5 (19%) nursing facilities currently meet the minimum staffing standards set out in the final requirements of the federal rule released today by the Centers for Medicare and Medicaid Services (CMS).

CMS adopted staffing standards that are similar to the staffing requirements in the rule proposed last year, which included minimum staff levels of 0.55 registered nurses and 2.45 nurse aide hours per resident day. The final requirements of the rule maintain these staff levels, and add an overall staffing requirement of 3.48 hours per resident day. The rule also requires a registered nurse on staff 24 hours per day, 7 days per week.

Nearly 60% of facilities currently meet the overall staffing requirement of 3.48 hours per resident day, which has been set as the interim requirement in the rule. Fewer facilities (19%) would meet the final requirements that include minimums for registered nurses and nurse aides, which will be applied when the rule is fully implemented.

This analysis does not estimate which facilities would qualify for an exemption or how staffing levels will change between now and when the staffing standards take effect. Urban and rural facilities have different timelines to come into compliance with the rule, which this analysis also does not take into account.

Editor’s Note: For an in-depth analysis of the final nursing home staffing requirements, including data by state, rural and urban areas, and facility profit status, view KFF’s newest brief. This brief was updated on April 24th, 2024 to reflect a CMS statement that the final requirements of the rule must be met by May 2029 for rural facilities. A previous version of this brief cited May 2028, which reflected the date written into the text of the regulation. 

On April 22, 2024, the Centers for Medicare and Medicaid Services (CMS) released a highly-anticipated final rule that creates new requirements for nurse staffing levels in nursing facilities, settings that provide medical and personal care services for 1.2 million Americans, and for which the adequacy of staffing has been a longstanding issue. CMS received nearly 50,000 comments on the proposed rule, ranging from comments that strongly supported the proposed standards to those that opposed them. Among those comments, the nursing home industry suggested the rule was too onerous, given staffing shortages and costs, and could lead to nursing facility closures, while resident and family advocates suggested the proposed standards were too weak to address quality concerns.

In the final rule, CMS adopted staffing standards that are mostly similar to the staffing requirements in the proposed rule. Requirements will take effect in different phases. When fully implemented for all facilities, nursing facilities will be required to meet minimum nurse staffing levels of 3.48 hours per resident day (HPRD), including 0.55 registered nurse (RN) and 2.45 nurse aide HPRD. Additionally, they will be required to have an RN on duty 24 hours a day, 7 days a week (24/7). By May 2027, prior to full implementation, the final rule requires nursing facilities to have an RN on duty 24/7 and at least 3.48 HPRD of total nurse staffing hours irrespective of staff type, without the more specific RN and nurse aide requirements that take effect when the rule is fully implemented. Timelines for meeting the interim and final requirements will differ for urban (10,400 facilities, or 73% of facilities) and rural facilities (4,000 facilities, or 27% of facilities). The interim requirements must be met by May 2026 for urban facilities and May 2027 for rural facilities. The final requirements must be met by May 2027 for urban facilities and May 2029 for rural facilities.

This analysis uses the most recent publicly-available data to examine the percentage of nursing facilities that currently meet the minimum staffing requirements in the final rule, which phases in beginning in May 2026 for some facilities. Specifically, this analysis calculates the share of facilities that currently meet the overall requirement of 3.48 HPRD (regardless of staff type) and the share that meet the fully implemented, more specific staffing standards (HRPDs of 3.48 overall, 0.55 for RNs, and 2.45 for nurse aides). This analysis uses Nursing Home Compare data from March 2024, which includes 14,403 nursing facilities (97% of all facilities, serving 1.18 million or 98% of all residents), and reflects staffing levels from July to September 2023. Due to data limitations, this analysis does not look at the 24/7 RN requirement. See Methods for more information.

KFF estimates that 19% of nursing facilities would meet the minimum HPRD staffing standards under full implementation of the final rule with their current staffing levels (Figure 1). Nearly 60% of facilities would meet the interim requirement of an overall requirement of 3.48 HPRD, but fewer facilities would meet the RN and nurse aide provisions that are required when the rule is fully implemented (49% and 30% respectively; data not shown).

The final rule also includes new reporting and assessment requirements and the process by which facilities may qualify for an exemption from the minimum staffing provisions. The final rule also indicates that CMS will release additional details later this year on how the $75 million investment in a nursing home staffing campaign will be structured. As noted in the proposed rule, CMS aims to balance the goal of establishing stronger staffing requirements against the practicalities of implementation and costs.

The analysis does not evaluate facilities’ ability to comply with other requirements in the final rule, including the requirement to always have a registered nurse on duty 24/7 or the ability to meet the new reporting and assessment requirements due to data limitations (see Methods). The analysis also does not estimate which facilities would qualify for an exemption or how staffing levels will change between now and when the staffing standards take effect.

A forthcoming analysis will look at the share of facilities that currently meet the new standards across a variety of dimensions, including ownership, state, and urban or rural location.

Methods

This analysis uses Nursing Home Compare as of March 2024 and reflects staffing levels from July to September 2023. Nursing Home Compare is a publicly available dataset that provides a snapshot of information on quality of care and key characteristics for approximately 14,900 Medicare and/or Medicaid-certified nursing facilities. This analysis drops about 3% of nursing facilities, including the facilities in Guam and Puerto Rico and nursing facilities for which there was not staffing data available for the fourth quarter of 2023, for a total analytic sample of 14,403 facilities. The number of facilities identified in this analysis as meeting/not meeting requirements may differ from CMS’ estimates due to different years and quarters of data used for estimates.

The Office of Management and Budget’s (OMB) delineation of metropolitan and micropolitan statistical areas were used to designate rural and urban areas. Urban and rural facilities have different timelines to come into compliance with the rule, which this analysis does not take into account. This analysis reflects compliance rates if the HPRD requirements were in effect now for all facilities.

Due to the limitations of publicly available data, this analysis does not look at facilities that meet the requirement to have an RN on staff 24 hours a day, seven days a week (24/7). Nursing home staffing data is calculated from the Payroll Based Journal (PBJ), which includes data on the total number of RN hours worked per day at a facility, but no data on the timing of shifts. This limits our understanding of whether shifts were worked simultaneously by multiple employees (possibly not fulfilling the 24-hour requirement) or whether those hours were spread out over a 24-hour period (fulfilling the 24-hour requirement).

On April 24, the Supreme Court will hear Idaho v. United States—the second case this term involving access to abortion. In a new brief, KFF examines what’s at stake, focusing on whether the Emergency Medical Treatment and Active Labor Act (EMTALA)—a federal law requiring nearly all hospitals to ensure emergency room patients are stable before they are discharged from hospital care—preempts state abortion laws. 

The new brief reviews the background on the case and EMTALA, including guidance from the Biden Administration, legal challenges, the issues the Supreme Court will consider, and the potential impact of a ruling.

Idaho has an abortion ban that only includes an exception to save the pregnant person’s life and argues that EMTALA does not preempt its ban. In states with abortion bans that don’t have an exception for health, a hospital, can’t under state law, provide abortion as a stabilizing treatment for a pregnant patient presenting with conditions that risk severe and lasting harms, such as sepsis, kidney failure, and fertility loss. Idaho contends there is no conflict between state and federal law, since EMTALA requires physicians to do everything possible to preserve the life of both the pregnant person and their fetus. 

The Biden Administration considers abortion care to protect the health of a pregnant person—not only to save a life—an integral component of the type of stabilizing treatment that EMTALA requires hospitals to provide. A ruling in favor of the federal government would mean pregnant patients could obtain abortion care if needed to stabilize their health in hospital emergency rooms throughout the country, even in states with an abortion ban that only has a life exception.

Key Takeaways:

• On April 24, 2024, the Supreme Court will hear the second case this term involving access to abortion: Idaho v. United States. At stake in this case is whether the Emergency Medical Treatment and Active Labor Act (EMTALA), a federal law requiring hospitals to provide stabilizing treatment to patients who present to their emergency rooms, preempts state abortion laws and requires hospitals that accept Medicare to provide abortion care when it is necessary to stabilize a patient’s condition, even when this abortion care violates state law.
• The state of Idaho has an abortion ban that only includes an exception to save the life of the pregnant person. It contends that EMTALA does not preempt its abortion ban because there is no conflict between the state and federal law since EMTALA requires physicians to do everything in their power to preserve the life of both the pregnant person and the fetus.
• The Biden Administration maintains that EMTALA requires hospitals to provide stabilizing treatment, including abortion, to preserve the health of a pregnant person, not only in situations where abortion is the necessary treatment to save a patient’s life.
• This case not only has implications for access to pregnancy-related emergency care, including abortion, but could also have ramifications for a pregnant person’s right to preserve their own health and clinicians’ autonomy to manage pregnancy-related medical emergencies based on accepted standards of care.

Introduction

On April 24, 2024, the Supreme Court will hear the second case this term involving access to abortion: Idaho v. United States, which has been consolidated with Moyle v. United States. At stake in this case is whether the Emergency Medical Treatment and Active Labor Act (EMTALA), a federal law requiring hospitals to provide stabilizing treatment to patients who present to their emergency rooms, preempts state abortion laws and requires hospitals to provide abortion care when it is necessary to stabilize a patient’s condition, even when this abortion care violates state law. While all state abortion bans have an exception for pregnancies that jeopardize the life of a pregnant person, some do not have an exception that would allow an abortion to preserve the health of the pregnant person. Even in states with health exceptions, the exception might be very narrow and not well defined, leaving significant gaps in emergency medical care for pregnant people. EMTALA, however, requires that hospitals provide stabilizing care to patients with emergency medical conditions, including conditions that may harm their health. According to Department of Health and Human Services (HHS) guidance issued in the wake of the Dobbs decision, EMTALA requires hospitals to provide abortion care to pregnant patients with emergency medical conditions when abortion is necessary to stabilize the patient’s condition. The Court’s decision in this case could impact access to abortion in emergency situations across the country and potentially lay the foundation for future challenges involving state laws granting fetal personhood. This brief explains the arguments presented by Idaho and the Biden Administration in the lawsuit, the potential Supreme Court decisions, and the implications for pregnant people seeking emergency health care in states with abortion bans.

What Is EMTALA?

In 1986, Congress enacted the Emergency Medical Treatment and Active Labor Act (EMTALA) to prevent hospitals from “dumping” or transferring uninsured patients to public hospitals without consideration of their condition or attempting to stabilize them before they were transferred. The law requires Medicare-participating hospitals – effectively all acute care hospitals – to perform an appropriate medical screening examination to any patient who presents to their dedicated emergency department. If a patient is identified as having an emergency medical condition, the hospital must provide stabilizing treatment within the hospital’s capability or transfer the patient to another medial facility that has the capabilities to provide treatment to stabilize the emergency medical condition.

The law defines an emergency medical condition as: “A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual  (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, serious impairment to bodily functions or serious dysfunction of any bodily organ or part or with respect to a pregnant woman who is having contractions that there is inadequate time to effect a safe transfer to another hospital before delivery or that transfer may pose a threat to the health or safety of the woman or the unborn child.”  The provisions about pregnant women and the unborn child were added to the Act in 1989 in response to reports of hospitals refusing to treat uninsured pregnant women in labor.

The law includes a section that states: “The provisions of this section do not preempt any state or local law requirement, except to the extent that the requirement directly conflicts with a requirement of this section.”

HHS, through its Office of the Inspector General (OIG), may impose a civil monetary penalty on a hospital ($119,942 for hospitals with over 100 beds, $59,973 for hospitals with under 100 beds per violation) or physician ($119,942 per violation). The HHS OIG may also exclude physicians from participating in Medicare and state health care programs if they are found to be violating EMTALA. Individuals who suffer personal harm as a direct result of a hospital’s violation may bring a civil action against the hospital and obtain personal injury damages.

What Guidance Has the Biden Administration Issued About EMTALA?

In September 2021, after Texas implemented its civil abortion ban SB 8, the Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality issued guidance titled, “Reinforcement of EMTALA Obligation specific to Patients who are Pregnant or are Experiencing Pregnancy Loss.” While this guidance does not state abortions must be provided if that is the necessary stabilizing treatment, it does state that: “A physician’s professional and legal duty to provide stabilizing medical treatment to a patient… preempts any directly conflicting state law or mandate that might otherwise prohibit or prevent such treatment.”

As states were starting to implement abortion bans after the Dobbs decision, HHS issued guidance in July 2022 regarding the enforcement of EMTALA. The guidance clarifies that hospitals and physicians have obligations to provide stabilizing care, including abortion, if that is the necessary stabilizing treatment when a patient presenting at an emergency department is experiencing an emergency medical condition.

On January 22, 2024, the Biden Administration announced a broad plan to educate patients on their right to abortion services in emergency situations and hospitals on their obligation to provide those emergency services.

What Are the Legal Challenges?

After HHS issued their 2022 guidance, two lawsuits were filed in federal courts. The state of Texas sued HHS to block enforcement of the HHS guidance in Texas, arguing that EMTALA does not authorize the federal government to “compel” clinicians to provide abortion care. Texas was joined by religious anti-abortion physician organizations, which argue that the guidance infringes on their conscience rights in violation of the federal Religious Freedom Restoration Act (RFRA) by requiring them to provide abortion care in situations contrary to their beliefs. In another case, HHS sued the state of Idaho to block enforcement of its abortion ban to the extent it conflicts with EMTALA.  The Idaho legislature subsequently intervened to defend the state law. These two cases have resulted in conflicting decisions in the federal district courts and the federal courts of appeal.

In the Idaho case, the federal district court concluded that because the Idaho law did not include exceptions for health or life, the law conflicted with EMTALA. At the time the district court considered the case, the Idaho law did not have an exception for situations that threatened the life or health of the pregnant person. The law only allowed physicians to assert a defense (see box below) to criminal prosecution if in their good faith medical judgment performing the abortion was “necessary to prevent the death of the pregnant woman.” Having an affirmative defense instead of an exception means that a physician could be prosecuted and then would need to assert their defense and would bear the burden of proof to demonstrate that they provided the care to save the patient’s life. The district court blocked Idaho from enforcing the abortion ban to the extent it conflicts with EMTALA while the litigation proceeded.

After the district court issued its decision, the Idaho legislature amended the law changing the affirmative defense to an exception for life. The law now imposes penalties on physicians who perform abortions unless “[t]he physician determined in his good faith medical judgment and based on the facts known to the physician at the time, that the abortion was necessary to prevent the death of the pregnant woman.” The State of Idaho and their legislature appealed to the 9^th Circuit Court of Appeals, which initially reversed the district court’s ruling. Later, a full panel of judges from the 9^th Circuit reinstated the district court’s ruling blocking the provisions of the law that conflict with EMTALA. Idaho and the Idaho Legislature appealed to the Supreme Court, which took the case and allowed the Idaho law to be fully enforced while the case proceeds.

The federal district court in Texas reached the opposite decision and blocked HHS from enforcing its EMTALA guidance, but only in Texas. The court highlighted that the HHS guidance states that abortion may be required for medical conditions that are likely to become emergent. Texas law requires that life-threatening physical conditions already be present for an abortion to be excepted from its abortion ban. The court concluded that Texas is likely to succeed on their claim that the HHS Guidance exceeds HHS’s statutory authority: “The Guidance goes well beyond EMTALA’s text, which protects both mothers and unborn children, is silent as to abortion, and preempts state law only when the two directly conflict. Since the statute is silent on the question, the Guidance cannot answer how doctors should weigh risks to both a mother and her unborn child.” The court similarly sided with anti-abortion physician organizations on their conscience objections claims, stating that the guidance does not contain any exceptions for clinicians with sincerely held religious beliefs. However, the court did not rule definitively that a religious exemption is required under federal law. The Biden Administration contends that EMTALA requires hospitals, not individual doctors, to provide stabilizing care, and appealed this decision to the 5^th Circuit Court of Appeals. The Court affirmed the lower court’s ruling blocking HHS from enforcing the abortion-related EMTALA guidance. On April 1, 2024, the Biden Administration appealed the 5^th Circuit’s ruling to the Supreme Court, asking the Court to hold this case pending the outcome in the Idaho case and then apply that decision to this Texas case.

What Is the Supreme Court Considering?

The Supreme Court will consider whether EMTALA preempts Idaho’s abortion ban in situations in which terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health, but the state prohibits a physician from providing that care.

The Biden Administration’s position is that EMTALA preempts Idaho’s abortion ban when a pregnant person presents in an emergency room with a condition that threatens their health, and abortion is the standard of care to stabilize the patient. The Biden Administration contends the hospital must provide an abortion when that is the “necessary stabilizing treatment” to prevent lasting harms including sepsis, uncontrollable bleeding, kidney failure or loss of fertility. The Idaho abortion ban is in direct conflict with the requirement of EMTALA to provide stabilizing care and is therefore preempted by EMTALA. The Administration argues: “Many pregnancy complications do not pose a threat to the woman’s life when she arrives at the emergency room—but delaying care until necessary to prevent her death could allow her condition to deteriorate, placing her at risk of acute and long-term complications.” EMTALA creates an obligation to allow the pregnant person, not the fetus, to receive and proceed with treatment.

As evidence that Congress did not intend to exclude abortion care from EMTALA, the Administration  highlights that although the Affordable Care Act (ACA) allows states to prohibit abortion in qualified health plans or refuse to include abortion as a covered essential health benefit, the ACA also states that “[n]othing in this Act shall be construed to relieve any health care provider from providing emergency services as required by State or Federal law, including… EMTALA.”  The Administration maintains that EMTALA mentions a specific form of stabilizing treatment in one circumstance, when a pregnant woman is in labor and having contractions. “But by singling out ‘having contractions,’ EMTALA expands the definition of ‘emergency medical condition’ to include labor which otherwise might not satisfy the [law’s] definition and requires a particular treatment. In identifying a specific stabilizing treatment in that one instance, Congress did not override EMTALA’s general stabilization obligation – or preclude any other necessary stabilizing treatment.”

Idaho argues there is no conflict between EMTALA and Idaho’s Defense of Life Act because EMTALA requires physicians to do everything in their power to preserve the life of both the pregnant person and their fetus. Idaho maintains that EMTALA was enacted to ensure that hospitals do not “dump” uninsured patients, not to create any standards of care, and only requires hospitals to offer treatments to uninsured patients that are available to insured patients. The only form of stabilizing treatment expressly required by the statute is delivering a baby when a pregnant woman with contractions has an emergency medical condition. EMTALA treats an “unborn child” or fetus as a patient, and expressly requires that the fetus of a pregnant woman in labor be delivered.

Idaho contends that EMTALA does not preempt their abortion ban because EMTALA states that it preempts state law only when it contradicts the statute’s express requirements. Idaho further argues that Congress did not intend for EMTALA to preempt state regulation of health care. Idaho points to the Hyde Amendment as further evidence that Congress did not intend EMTALA to require abortion care. If the Biden Administration guidance is implemented, they argue, then hospitals will be required to provide abortions in cases where the hospital cannot use federal funds, as the abortions do not fall within a Hyde exception.

What Would Be the Impact of a Ruling in Favor of the Federal Government?

If the Supreme Court rules in favor of the Biden Administration, hospitals in states where abortion is banned or restricted will be required to provide abortion care in emergency situations to stabilize the health of a pregnant person or they will face monetary penalties (discussed above). This means that, in practice, pregnant patients will be able to obtain abortion care to stabilize their health in hospital emergency rooms throughout the country, even in states with an abortion ban that has only an exception to preserve the pregnant person’s life. This will give clinicians protections to provide this abortion care in states that ban or limit abortion without risking criminal or civil penalties. Many states with abortion bans either have no health exception or a very narrow health exception. In addition, many states do not defer to the doctor’s medical judgment that an abortion qualifies for an exception under state law, which has made clinicians hesitant to provide care that could later be prosecuted and reviewed by a court.

Idaho and other states with abortion bans claim that a ruling in favor of the federal government would limit their sovereign ability to regulate the practice of medicine. In addition, the Christian Medical and Dental Associations claim that the EMTALA guidance “imposes a substantial burden on the many healthcare professionals whose religious beliefs compel them not to participate in abortion”, forcing these physicians to pay a fine for following their sincerely held beliefs. The U.S. Conference of Catholic Bishops claim a ruling in favor of the federal government would prompt many Catholic medical practitioners and entities to opt out of programs covered by EMTALA which in turn would limit public access to health care in the future.

What Would Be the Impact of a Ruling in Favor of Idaho?

Impact in States Where Abortion Is Banned

A ruling in favor of Idaho will maintain the current patchwork of uneven access to medical emergency care for pregnant patients. Pregnant patients needing emergency abortion care in the 14 states that ban abortion and the states that severely restrict abortion would continue to be disproportionately impacted. This is because some states with abortion bans do not have health exceptions and those that do, do not make robust exceptions.

While all states have life exceptions, five states with abortion bans (Arkansas, Idaho, Mississippi, Oklahoma, and South Dakota) do not make exceptions for the health of the pregnant person. In these states, a hospital cannot legally provide abortion as a stabilizing treatment for a pregnant patient presenting with conditions that risk severe and lasting harms, including sepsis, kidney failure and loss of fertility, unless these conditions become life-threatening. And even in states that have exceptions for the health of the pregnant person, because these exceptions are often narrow and vague, pregnant people can still be denied emergency abortion care needed to preserve their health.

Due to the lack of health exceptions or meaningful and clear health exceptions in abortion bans and limits, physicians would continue to be reluctant to provide emergency abortion care. This chilling effect will persist, discouraging physicians from providing evidence-based emergency medical care, even in situations where they cannot prevent the loss of the pregnancy.

While the United States Conference of Catholic Bishops and other Catholic organizations assert in their amicus brief that pregnancy complications can always be safely and ethically treated without intentionally taking the life of an unborn child in a direct abortion, the American College of Obstetricians and Gynecologists (ACOG) and other medical professional organizations illustrate in their amicus brief some of the emergency situations clinicians might encounter and highlight the difficulty they may face in ascertaining whether an exception applies, stating that:

In many of the emergency medical conditions requiring abortion care, the loss of the pregnancy is inevitable. When a pregnant patient experiences PPROM [preterm premature rupture of the membranes] prior to viability, continuing the pregnancy risks serious health consequences including sepsis and death. Pre-eclampsia prior to viability also presents a risk of serious health consequences including seizure, stroke, multiple organ failure, and even death. An inevitable or incomplete abortion—commonly called a miscarriage—can cause excessive bleeding and risk of hemorrhage or infection and fetal or embryonic cardiac activity may remain. Other emergency situations occur precisely because a pregnancy is not viable and will not result in a live birth, like a molar or ectopic pregnancy. In these and other cases, abortion may be required to stabilize the patient.

This presents the second issue, timing. No clinical bright line defines when a patient’s condition crosses the lines of this continuum. At what point does the condition of a pregnant woman with a uterine hemorrhage deteriorate from health-threatening to the point that an abortion is “necessary” to prevent death? When is it certain she will die but for medical intervention?

These are questions that OBGYNs in states that ban abortion are currently facing. In a recent KFF national survey of OBGYNs, six in ten OBGYNs practicing in states where abortion is banned or where there are gestational limits say their decision-making autonomy has become worse since the Dobbs ruling. Four in ten OBGYNs in these states report they have personally felt constraints on their ability to provide care for miscarriage and other pregnancy-related medical emergencies since the Dobbs decision.

Seventeen women who experienced an obstetrical emergency while pregnant in a state with a near-total abortion ban submitted an amicus brief. They claim hospitals are engaging in dumping patients with pregnancy-related emergencies, the exact action EMTALA aims to block, rather than providing stabilizing care. After presenting at emergency rooms, these women were sent home with instructions to come back when their situations became more dire. While the delays in care did not help the fetus, many of them now suffer the health consequences of having their care delayed. These situations would continue to occur if the Supreme Court rules in favor of Idaho

Impact on Emergency Care in States Where Abortion Is Not Banned

In addition to those residing in states with abortion bans, a Supreme Court ruling that EMTALA does not preempt the Idaho abortion ban could also have an impact on people seeking emergency care in other states. Twenty-four states and DC have submitted an amicus brief claiming that allowing states to override EMTALA’s requirement to stabilize patients will drive more patients to amici States and “may result in more crowded waiting rooms, increased delays for urgent healthcare services, and overall strains on many amici States’ healthcare systems.”

Potential Broader Implications for Fetal Personhood

At the heart of this case, Idaho is asking the court to allow the state to recognize and protect the rights of a fetus over the health of the pregnant person. A decision in favor of Idaho, depending on how the court frames its decision, could crack open the door to future cases further recognizing the rights of embryos or fetuses, as did the Alabama Supreme Court’s IVF ruling. For instance, states may seek to mandate specific childbirth methods, such as a C-section contrary to the wish or beliefs of pregnant person to preserve the life of the fetus, or police the behavior of pregnant people to protect the fetus.

Idaho and the Idaho Legislature cite their law which stipulates that, “The people of Idaho recognize the “life of each human being begins at fertilization, and preborn children have interests in life, health, and well-being that should be protected.” The Charlotte Lozier Institute, an anti-abortion advocacy organization, contends in their amicus brief that the Biden Administration is disregarding EMTALA’s “plain text requiring physicians to protect the life of unborn children.” Some lower courts have ruled that hospitals have “dual stabilization requirements” to the pregnant person and the fetus, and the state can direct hospitals to prioritize the survival of the fetus over the wellbeing of the pregnant person.

While states have focused on restricting abortion care, this has broader implications for a pregnant person’s right to make decisions about how they want to manage their own pregnancy including the right to preserve their own health, and clinicians’ autonomy to manage pregnancy-related medical emergencies based on accepted standards of care.

Mergers and acquisitions involving hospitals and other health care providers are drawing attention from federal and state regulators, including the Federal Trade Commission, and policymakers amid concerns that such consolidations can reduce competition and contribute to the high costs of health care.

A new KFF brief examines and summarizes the evidence about consolidation among health care providers as more community hospitals become part of a larger system, and more physicians are in practices owned by hospitals and systems.

Drawing from a wide variety of sources, the brief offers insights into the pace of consolidation among providers, its impact on prices and quality, and policy proposals aimed at reducing consolidation and increasing competition, such as:

• Following a wave of consolidation in the early- and mid-1990s, there were 1,573 hospital mergers from 1998 to 2017 and another 428 hospital and health system mergers announced from 2018 to 2023.
• The share of physicians working for a hospital or in a practice owned at least partially by a hospital or health system increased from 29% in 2012 to 41% in 2022. In addition, a growing share of physician practices are owned by other corporate entities, including insurance companies.
• While consolidation may allow providers to operate more efficiently, a substantial body of research shows that it generally leads to higher health care prices. The evidence overall does not show clear gains in access or quality. 
• Some studies have found that hospital consolidation can lead to lower wages for some skilled workers, such as nurses. The broader evidence on employment and compensation effects is limited, including the extent to which mergers that prevent closures could preserve jobs.
• State and federal policy proposals to address consolidation and increase competition include strengthening antitrust enforcement, reducing financial incentives for provider consolidation, increasing price transparency, and allowing more providers to enter the market. Each of these proposals would involve tradeoffs, and the extent to which they can reduce health costs is unclear since many markets already are highly concentrated.

The brief is part of KFF’s expanding work examining the business practices of hospitals and other providers, and their impact on costs and affordability. 

National health spending totaled $4.5 trillion in 2022—17% of gross domestic product (GDP)—and is projected to grow faster than GDP through 2031, contributing to higher costs for families, employers, states, and the federal government. As policymakers consider a variety of strategies to make health care more affordable, they have been increasingly attentive to consolidation in health care markets—including mergers and acquisitions of health care providers—and the potential effects of consolidation on the cost and quality of care and other outcomes. Consolidation may allow providers to operate more efficiently, and could help struggling providers keep their doors open in underserved areas, but also often reduces competition. A substantial body of evidence has found that consolidation has led to higher prices, but the evidence on quality is unclear.

In response to concerns about the effects of consolidation and reduced competition on prices and quality, the Federal Trade Commission (FTC) recently authorized a lawsuit to block a hospital acquisition in North Carolina. And, just last month, the FTC, Department of Justice, and Department of Health and Human Services issued a request for information (RFI) seeking input on the effects of consolidation involving health care providers and related products and services as part of a broader effort to clamp down on anticompetitive practices.

This issue brief identifies ten things to know about consolidation in health care provider markets, touching on topics such as the different types of consolidation, trends, ways in which consolidation can be beneficial or harmful for patients and other consumers, some key findings from existing research, and policy options for increasing competition. This brief focuses on consolidation among health care providers, rather than health insurers, and builds on a 2020 KFF issue brief on provider consolidation. More recent research has not altered the key takeaways pulled from that brief.

Efforts to promote more competitive provider markets could help address health spending and affordability issues, but also entail a number of challenges, given that many markets are already highly concentrated and that some regions cannot support competitive markets. Some have considered more direct regulation of prices and spending, and the two approaches could play complementary roles when addressing rising health care costs, such as by encouraging providers to compete on quality when prices are regulated.

1. Consolidation in health care markets can take many forms and involve various types of providers

Health care consolidation often refers to scenarios where hospitals and other health care entities join together under common ownership through either a merger or acquisition (referred to as “mergers” in this brief). There are three main types of mergers:

• Horizontal mergers occur when there is consolidation between entities that offer the same or similar services, such as when a health system acquires a hospital or when two physician practices that provide overlapping services merge. For instance, in August 2023, Oregon Health & Science University and Legacy Health—two of the largest health systems in the Portland area—announced plans to merge.
• Vertical mergers occur when there is consolidation between entities that offer different services along the same supply chain, such as when a hospital or health plan acquires a physician practice. For instance, in May 2023, the health system HCA Healthcare announced a deal to acquire 41 urgent care centers in Texas, where HCA already had a large presence. Some mergers may entail both vertical and horizontal consolidation (e.g., if a health system acquires a physician practice that provides services offered by the system’s existing physician group).
• Cross-market mergers occur when there is consolidation between two providers that operate in different geographic markets for patient care. For example, in March 2024, Kaiser Permanente closed its merger with Geisinger Health through a new organization called Risant. These systems operate in different regions of the United States, with Kaiser Permanente operating in five states in the West (including California) and Georgia, Maryland, Virginia, and DC and Geisinger operating in Pennsylvania.

Aside from merging, health care entities can form other types of affiliations without necessarily changing ownership, which may also have implications for patient care. Examples include the creation of accountable care organizations (i.e., groups of doctors, hospitals, and other providers who form partnerships to collaborate and share accountability for the cost and quality of care delivered to their patients) and joint ventures (i.e., agreements to collaborate on a particular goal, such as a health system and group practice that work together to create a new ambulatory surgery center). These affiliations can raise similar issues as mergers and are sometimes referred to as “soft” forms of consolidation.

2. There has been a large amount of consolidation in provider markets over the past 30 years

Provider markets have become increasingly consolidated over the past 30 years. Following a wave of consolidation in the early- and mid-1990s, there were 1,573 hospital mergers from 1998 to 2017 and another 428 hospital and health system mergers announced from 2018 to 2023. The share of community hospitals that are part of a larger health system also increased from 53% in 2005 to 68% in 2022 (see Figure 1). Relatedly, the share of physicians working for a hospital or in a practice owned at least partially by a hospital or health system increased from 29% in 2012 to 41% in 2022.

Consolidation has also contributed to the emergence of large health systems. For example, the ten largest health systems (see Table 1) accounted for about one in five (22%) of nonfederal general acute care hospital beds in 2022. These systems are the size of large corporations. For example, HCA Healthcare, which operates the largest number of nonfederal general acute care hospital beds in the country, had greater operating revenues than each of Netflix, Uber, and Starbucks in 2023. AdventHealth, the smallest of the ten largest health systems in terms of beds, had greater operating revenues than Zoom and Lyft combined in 2023 (as did Community Health Systems, the smallest of the ten largest systems in terms of operating revenues). Consolidation, which often occurs between providers based in the same region, has also contributed to highly concentrated markets where patients have limited options among large provider organizations.

Today, many provider markets are highly concentrated, particularly markets for hospital care. One study estimated that the vast majority (90%) of metropolitan statistical areas (MSAs) had highly concentrated hospital markets in 2016, while another estimated that the share of metro areas with highly concentrated hospital markets increased from 71% to 77% over the period from 2017 to 2021 (differences in magnitudes across these studies likely reflect their distinct methods, including market definitions). The former also found that most MSAs (65%) had highly concentrated specialist physician markets in 2016, and nearly two in five (39%) had highly concentrated markets for primary care physicians. Physician markets may have become more concentrated in recent years due to the ongoing trends in consolidation described above.

3. Corporations such as CVS, Amazon, and UnitedHealth and private equity firms have recently acquired many physician practices

In addition to hospitals and health systems, other types of entities have also been involved in a large number of acquisitions in recent years:

• Corporate buyers. Corporations that have not traditionally specialized in the provision of health care services—including large national companies such as CVS, Amazon, and UnitedHealth—have acquired many physician practices in recent years. The share of physicians employed by corporate entities increased over a three-year period from 15% in January 2019 to 22% in January 2022. Optum, a division of the insurer UnitedHealth, now employs or is affiliated with about 10% of all practicing physicians. Some policymakers have expressed concern about the role that large corporate buyers could have in increasing consolidation and reducing competition, which could lead to higher costs and reduced quality, although evidence is not yet available on this trend.
• Private equity firms. Private equity is a form of corporate ownership that often entails relying on loans to acquire a business, taking it private (if not so already), and attempting to increase its value with the goal of selling it at a profit in three to seven years. One common strategy is to consolidate providers through a series of mergers and acquisitions. Private equity provider acquisitions have increased by a large amount since 2010—e.g., with physician practice deals increasing more than six-fold from 2012 to 2021—though deals have slowed somewhat since a peak in 2021. Some policymakers have expressed concern about the role of private equity in consolidation and the effect of the short-term profit motive of private equity firms on the prices, quality, and financial standing of acquired providers. 

4. A substantial body of evidence shows that consolidation has led to higher prices, but the evidence on quality is unclear

Consolidation could in principle benefit consumers in some instances and be harmful in others. On the one hand, consolidation could allow providers to operate more efficiently, such as by obtaining supplies at steeper discounts (by purchasing them in greater volume); sharing resources (such as medical imaging equipment); and achieving the scale necessary to participate in value-based payment programs. These potential efficiencies could in turn benefit patients, for example, if they lead to higher quality care or reduced costs (e.g., if providers share savings through lower prices), and the latter could benefit health plan enrollees more generally to the extent that it leads to lower plan spending and premiums. On the other hand, consolidation often reduces market competition and therefore the pressure on providers to lower prices or invest in quality improvement. Critics have also questioned the extent to which mergers allow providers to operate more efficiently. Efficiencies may depend, in part, on the degree to which providers integrate their operations, which can be complex and may or may not be a priority.

The following discussion describes key findings from the research.

A substantial body of research shows that consolidation has led to higher health care prices, as noted in a 2020 KFF issue brief on provider consolidation. The evidence that consolidation leads to higher prices is strongest for hospitals, though studies that have evaluated physician and hospital-physician consolidation have also tended to find that they are associated with higher prices. Studies that have looked specifically at consolidation among nonprofit hospitals—which account for 58% of all community hospitals—have found price increases as well. A RAND Corporation review from 2022 (which also informs other sections of this brief) found that estimated price increases associated with hospital mergers have ranged from 3 to 65 percent. The large variation in estimated price increases may reflect differences in the types of mergers that were evaluated (e.g., the extent to which they reduced competition), the context of these mergers (e.g., the competitiveness of local insurance markets), and methodology. In addition to increases in the prices that commercial insurers pay providers, consolidation can also lead to higher Medicare reimbursement rates, as the program often provides greater reimbursement for a given service when provided in a hospital outpatient department versus a freestanding physician office (see discussion of site-neutral payment reforms below).

Relatedly, studies have typically found that consolidation leads to higher health care spending, which could increase costs for families, employers, states, and public programs, like Medicare and Medicaid. Several studies have found that consolidation leads to higher spending, which reflects both the price and volume of care. This includes studies evaluating hospital consolidation and hospital-physician consolidation. Only a small number of studies have evaluated physician consolidation, with mixed results. Increases in health care spending can be passed onto health plan enrollees through higher premiums and workers with employer-sponsored insurance through lower wages. Notably, a couple of studies have found an association between consolidation and premium increases, and one study found that hospital mergers led to decreases in wages among non-health care workers with employer health plans.

The evidence on the effect of provider consolidation on the quality of patient care is unclear. The evidence on the impact of horizontal and vertical consolidation on quality has been mixed, as described in a 2020 KFF issue brief and 2022 RAND Corporation review. For example, most of the research on horizontal hospital consolidation has found no difference¹  in or a negative impact on quality. Among other analyses, one study found that increased market concentration was associated with higher risk-adjusted one-year mortality rates for heart attacks and another found that hospital mergers were associated with a small decrease in patient experience measures and no changes in 30-day readmission and mortality rates (with inconclusive findings regarding clinical process measures). However, some studies have included mixed or positive findings relating to hospital consolidation. For example, a study funded by the American Hospital Association found that mergers were associated with decreases in 30-day readmission rates but no change in 30-day mortality rates (though an earlier version of the study found decreases in mortality rates as well).

The evidence is also mixed on the effects of vertical hospital-physician consolidation on quality. For example, one fairly recent study found that clinical process and patient experience measures were “marginally” higher for patients when their primary care physician was part of a system, another study found no difference in patients’ 30-day readmission rates when their primary care physician was part of a large system, and a third study found that complications following colonoscopies were higher for patients when their gastroenterologist was part of a system (though the evidence was less clear for clinical process measures).

Interpreting the evidence on quality is further complicated by the fact that there are many dimensions and measures of quality that have been or could be used to assess the effects of consolidation and that it could take time for changes in quality to materialize. Additionally, it is likely that the effects of consolidation vary based on the extent to which providers have integrated their operations and across different patient populations.

5. Mergers between hospitals and health systems can lead to higher prices even when entities operate in different markets

While policymakers and regulators have historically focused on consolidation within the same region, many mergers have occurred between hospitals and health systems that operate in different regions, as discussed in a KFF issue brief, including several multi-billion dollar deals over just the past couple of years. The small number of studies that have focused on cross-market mergers have estimated price increases ranging from 6% to 17%, even though these deals entail hospitals and health systems that are not competing against each other in the same area. There are a few reasons why cross-market mergers might lead to price increases. For instance, a combined health system with providers in, say, different areas of a state may be able to use its dominant position in one market to negotiate higher prices in another when contracting with a given health plan (e.g., a state employee plan with enrollees that reside in several markets). As another example, a large system that, say, acquires a small hospital may have more expertise in bargaining with insurers, which it could use to negotiate for higher prices.

6. The impact of consolidation on the availability of health care services for rural and other underserved patients is unclear

Consolidation could in principle have mixed implications for access to care. For example, it is conceivable that the acquisition of a small, financially struggling, rural hospital by a large health system based in another region could increase the availability of services in the community in some instances and reduce it in others. On the one hand, being acquired could benefit the hospital financially—such as by providing access to a wide range of resources, managerial expertise, and capital—which could help the hospital keep its doors open and maintain or expand the services it offers. On the other hand, the system that acquires the rural hospital may be less responsive to the needs of the local community, such as when deciding whether to close the hospital or to stop offering certain services, such as maternity care (an outcome supported by some research, as described below).

A small number of studies have evaluated the association between consolidation with rural hospital closures and service eliminations, with mixed results. Two studies found that rural hospitals that merged with other hospitals or health systems were more likely to eliminate certain service lines, such as obstetrics care, and another study found that independent hospitals (urban and rural) that joined a health system were more likely to stop offering inpatient pediatric services. One study found that system affiliation was associated with a lower likelihood of closing among rural hospitals with weaker finances but a higher likelihood among those with stronger finances.

A small number of studies have evaluated the association between consolidation and access to care among Medicaid patients, also with mixed results. On the one hand, two studies found that physician practices were more likely to accept Medicaid patients after becoming affiliated with a health system. This may be because the broader system has a commitment or obligation to treat patients regardless of their ability to pay (e.g., for emergency care) or because efficiencies allow providers to treat more patients. On the other hand, one study found that increases in hospital market concentration were associated with fewer Medicaid admissions and a shift in care from nonprofit to public hospitals. This could be because increases in commercial prices resulting from greater market concentration may lead private hospitals to focus more on commercial versus Medicaid patients. Another study found that system affiliation was associated with a decrease in Medicaid as a percentage of all hospital discharges, although that study also found that the number of beds in a hospital or health system was associated with an increase in Medicaid discharges as a share of the total.

A small number of studies have evaluated the effect of consolidation on hospital charity care and total community benefits, with mixed results. For example, one study found no association between the acquisition of independent hospitals and charity care or total community benefit spending overall but a decrease in the latter when focusing on hospitals acquired by an out-of-state system. Another study found that the association of higher market concentration with hospital charity care varied depending on the method used, with an increase under one approach and no difference under another. One study found that higher market concentration was associated with higher income thresholds for charity care eligibility, which effectively increases the number of patients who could qualify for charity care in a hospital.

7. Hospital consolidation can lead to lower wages for some skilled workers, such as nurses, but the broader evidence on employment and compensation effects is limited

Consolidation could in principle have both benefits and drawbacks for health care workers. On the one hand, consolidation could increase the negotiating leverage of hospitals and their ability to extract concessions from workers. For example, in 2023, a coalition of labor unions filed a complaint with the DOJ that UPMC, a large health system in Pennsylvania, had used its market power to suppress the wages of nurses and other health care workers, increase workloads, and restrict the ability of health care workers to seek better employment elsewhere. Mergers could also lead to layoffs, for example, to the extent that providers consolidate their staff and operations. On the other hand, health care workers could benefit from hospital mergers in some scenarios where consolidation allows hospitals to remain open and operate more efficiently. For example, the acquisition of a struggling rural hospital by a health system could help the facility sustain its operations in certain circumstances, which could protect jobs and possibly bolster wages.

A couple of studies have found that hospital consolidation has led to lower wages for some skilled workers, such as nurses, though the implications of other studies on health care worker wages are less clear. For example, one study found that hospital mergers were associated with lower wages for nurses and pharmacy workers and for skilled nonmedical workers following mergers that caused large increases in market concentration (but not for unskilled workers). Research from the Center for Economic and Policy Research also found that increases in hospital market concentration were associated with lower wages for nurses in small metropolitan statistical areas. An earlier study did not find consistent evidence when evaluating nurses’ wages but did find that hospital mergers in California were associated with greater work effort (as measured by patient caseload). A small number of studies that looked more broadly at the financial impact of consolidation, including average compensation across all hospital workers, have produced mixed results.

Some studies find that hospital consolidation has led to reductions in staffing, though others have not, and the evidence is unclear on whether mergers avert closures, which could preserve jobs. A small number of studies have analyzed the effects of hospital consolidation on employment, with some finding an association with reduced staffing levels. For example, one study evaluating independent hospitals in New York found an association between joining a system and a reduction in employment, especially among employees with overhead and support functions. However, other studies have found no differences or inconsistent or unclear results. Additionally, as noted above, there is no clear evidence regarding the effect of mergers on hospital closures. If mergers lead to efficiencies that prevent closures, they may help preserve jobs.

8. The FTC, the DOJ, and state antitrust agencies each play a role in challenging consolidation and other potentially anticompetitive practices

Federal and state antitrust agencies each play a role in challenging consolidation and other potentially anticompetitive practices of health care providers and other businesses, as described in a KFF issue brief. At the federal level, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) share responsibility for enforcing federal antitrust laws, including the Sherman Act, the Clayton Act, and the FTC Act. State attorneys general (AG) offices also have the authority to bring action under federal antitrust law, as well as under state statutes, which sometimes expand upon federal law. Antitrust agencies challenge mergers, acquisitions, and other practices that may hinder competition (such as the use of anticompetitive contract clauses). They do so to promote competitive markets, often for the benefit of consumers (such as patients and health plan enrollees).

There are at least a few challenges that may limit the ability of the federal government and states to foster competitive provider markets through antitrust enforcement:

• It is difficult to break up mergers after they have already occurred, and many provider markets are already highly concentrated. Breaking up a merger after providers have already consolidated can be difficult. At the same time, regulating the behavior of merged providers—such as through restrictions on the prices they charge—may be difficult to monitor and enforce on an ongoing basis.
• Some regions cannot support competitive provider markets. For instance, rural communities may not have enough residents to support several providers that offer the same service.
• Antitrust litigation can be complex and expensive. Without adequate funding, it may be impractical to challenge a large number of provider business practices that raise anticompetitive concerns.
• Antitrust agencies may have difficulty staying ahead of market trends. For example, it could take time for the government to develop strong guidelines for challenging vertical or cross-market mergers and to accumulate enough evidence to convince courts that these practices harm competition. In the meantime, these mergers will likely continue.
• The benefits of competitive provider markets for individuals with health insurance will depend in part on the competitiveness of health insurance markets. One study estimated that most MSAs (57%) had highly concentrated insurance markets in 2016. When insurance markets are not competitive, cost savings from competitive provider markets might not be fully passed along to consumers.

The FTC and DOJ have recently signaled an interest in expanding their scrutiny of different types of mergers. For example, in December 2023, the agencies released updated merger guidelines that indicate that they may challenge a broader range of deals. Among other changes, the guidelines expand the definition of highly concentrated markets, rely on a lower threshold for identifying large changes in market concentration, consider the combined effect of a series of acquisitions (e.g., of a health system acquiring several small physician practices over time), add an explicit discussion of the agencies’ views on how workers may be negatively impacted when their employers merge, and touch on cross-market mergers.

The FTC and DOJ have also indicated an interest in challenging provider acquisitions by private equity firms and private payers. For instance, the agencies, along with HHS, specifically mentioned these types of entities in a March 2024 request for information on the effects of transactions involving health care providers and related products and services. Further, in September 2023, for the first time, the FTC challenged a common strategy of private equity firms that entails amassing market power through a series of physician practice acquisitions.

9. Site-neutral payment reforms, if enacted, could reduce incentives for vertical consolidation by lowering the rates at which acquired providers bill Medicare

Policymakers have expressed interest in aligning Medicare reimbursement rates for outpatient services across care settings through “site-neutral payment reforms,” which could directly lower program costs and reduce the incentive for hospitals to buy up physician practices. Under current payment rules, Medicare reimbursement is often higher for a given outpatient service when provided in a hospital outpatient department versus a freestanding physician office or ambulatory surgical center. Two studies have found that these payment differences are associated with an increase in hospital-physician consolidation, which can allow providers to bill Medicare at higher rates.

Through legislation and rulemaking, Medicare has aligned payments for office visits across freestanding physician offices and off-campus hospital outpatient departments—which often resemble physician offices—as well as for other services for relatively new off-campus facilities. Policymakers have considered other site-neutral reforms with varying scope that would extend to additional sites of care and services. Proponents of these reforms assert there are no grounds to pay different amounts for the same service based on site of care (physician office or outpatient hospital department) while hospitals and other opponents counter that patients treated in hospital outpatient settings have greater needs than patients in physician settings and that their cost structure justifies higher payment rates.

10. Policymakers have considered a number of options to increase the competitiveness of provider markets

Several policies have been proposed to rein in provider consolidation or increase the competitiveness of provider markets in other ways:

• Strengthen antitrust enforcement. This approach would make it easier for the FTC and DOJ to enforce antitrust law. Specific policies include: requiring more providers to report planned mergers, lowering the legal standards by which mergers are deemed anticompetitive, and mandating that providers receive approval from the government before merging. Other proposals to strengthen antitrust enforcement include: eliminating state Certificate of Public Advantage (COPA) laws (which some states use to shield mergers from federal antitrust challenges in exchange for state regulation), increasing the scope of antitrust law (such as by giving the FTC full authority to regulate nonprofit providers and outlawing anticompetitive contracting clauses), and providing greater resources to agencies that enforce antitrust law.
• Reduce incentives for health care providers to consolidate. This could include site-neutral payment reforms (as described above), changes to the 340B program (which currently allows certain providers acquired by a 340B entity to purchase drugs at a substantial discount), and efforts to reduce the administrative burden of government regulations on providers (which may incentivize small practices that have difficulty shouldering these requirements to merge with other providers).
• Increase price transparency. Greater price transparency could help patients, plans, and employers shop for health care providers (e.g., to receive care from or include in provider networks) and may in turn encourage greater competition among providers. As discussed in a KFF issue brief, information about hospital and other health care prices remains elusive, despite recent federal transparency rules.
• Allow more providers to enter the market. This could include reforming state Certificate of Need (CON) statues (which can be used to limit, for example, the construction of new health care facilities) and scope of practice laws (which regulate what work various health care professionals, such as nurse practitioners, are allowed to perform).

Each of these proposals would involve tradeoffs that would be important to consider.

1. References to no differences, no changes, or no associations in this issue brief indicate that there were no statistically significant differences. ↩︎

Compared to the general population, individuals who are incarcerated have higher rates of mental illness, substance use disorder, and chronic disease. However, the federal “inmate exclusion” policy prohibits Medicaid coverage for people who are incarcerated (except for limited inpatient hospital services). When people leave incarceration, they are at greater risk of overdose death and suicide, as well as hospitalization and emergency department use. 

In a new explainer, KFF examines a new waiver opportunity that allows states to request a partial waiver of the inmate exclusion policy from the Centers for Medicare and Medicaid Services (CMS) to help smooth individuals’ transitions back into the community with “reentry services.” These services aim to improve health care transitions, increase continuity of health coverage, reduce disruptions in care, improve health outcomes, and reduce recidivism rates.KFF explains the current landscape of “pre-release” waivers across states. The explainer also provides background on the demographic characteristics and health needs of people who are incarcerated. 

Among the key takeaways:

• About 1.2 million people were incarcerated in federal and state prisons as of the end of 2022, and 660,000 people were held in local jails as of mid-year 2022. Millions more interact with the correctional system each year.
• Individuals who are incarcerated have higher rates of chronic diseases such as hypertension, tuberculosis, hepatitis, and HIV/AIDS than the general population and also have significant behavioral health needs. An estimated 65% of people incarcerated in prisons nationally have an active substance use disorder.
• Three states (California, Montana, and Washington) have approval to provide pre-release services to certain incarcerated, Medicaid-eligible individuals as of April of this year. California estimates that approximately 200,000 people each year will be eligible to receive pre-release services, and Washington estimates 4,000 people per year will receive them. Nineteen additional states have waiver requests pending with CMS.

Pre-release services vary by state but include (at a minimum) case management (to assess health and social needs and to assist individuals in obtaining services both pre- and post-release), medication-assisted treatment and counseling for substance use disorders, and a 30-day supply of prescription medications upon release.