Indiana Approves a Presumptively Anticompetitive Hospital Merger: Five Lessons for the Future of Antitrust in Healthcare

The Indiana Department of Health recently approved a major hospital merger in Terre Haute between Union Health and HCA Healthcare’s Terre Haute Regional Hospital. Under traditional antitrust analysis, the transaction is the kind of horizontal consolidation that would raise serious red flags. The combined system will control nearly all inpatient hospital services in Vigo County, and the state itself acknowledged that the merger is “presumptively anticompetitive.”

Yet the deal moved forward, largely because it was evaluated not under federal merger law, but under Indiana’s Certificate of Public Advantage (COPA) framework, which allows the state to approve consolidations in exchange for price, quality, and service commitments enforced through regulatory oversight.

The decision, and the debate around it, offers a useful case study in the ongoing tension between competition policy and states’ desire to preserve access, stabilize financially strained hospitals, and maintain local control. For healthcare companies, insurers, providers, and counsel, the Indiana approval provides five important lessons.

FTC Enforcement of Interlocking Directorates: What Health Care Entities Should Know

By Christopher Gordon, Daniel Berick and Anushkay Raza on November 4, 2025 Posted in Antitrust, DOJ, FTC, Governance/Management

For many health care organizations, including hospital systems, physician groups, and private equity–backed health care platforms, board and governance structures have grown increasingly complex as the industry consolidates and integrates across service lines. It is common for executives, physicians, and investor representatives to hold board seats or observer roles across affiliated or partnered entities. While such arrangements may promote strategic collaboration or oversight, recent enforcement activity by the Federal Trade Commission (the “FTC”) underscores the need for careful attention to potential interlocking directorates under Section 8 of the Clayton Act, particularly when governance overlaps occur among entities that provide competing services or operate in overlapping geographic or patient markets.

U.S. Government Shutdown 2025 (Week 1): Early Insights into FDA Operations

By Delia Deschaine, John Wyand and Xiaomei Cai on October 13, 2025 Posted in Events, FDA

The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week. The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse.

The U.S. Food and Drug Administration (“FDA”), tasked with protecting public health by ensuring the safety, effectiveness and quality of drugs, biologics, medical devices, food and other regulated products within the broader Department of Health and Human Services (“HHS”), will undoubtedly experience disruptions on its operations in this period.

FDA is not expected to go dark completely. The FY 2026 HHS Contingency Staffing Plan[1] and the FDA-specific contingency plan[2] released right before the shutdown lay out how the Department and FDA will operate in the absence of enacted annual appropriations. These plans provide a roadmap to ensure most of FDA’s core functions continue to operate during this time. This is achieved through two main mechanisms: (1) exempting activities funded through carryover user fee funding and other unlapsed funding; and (2) relying on exclusions in the Anti-Deficiency Act (“ADA”) to continue activities related to imminent threats to the safety of human life or protection of property. Under the umbrella of these exemptions and exclusions, a majority (86%) of FDA staff are expected to be retained during the lapse. This, however, does not obscure the fact that a significant number of FDA’s responsibilities will be constrained by the lapse. Such responsibilities are still critical to protecting and promoting public health.

Healthcare in the Crosshairs: FTC’s New Playbook on Non-Compete Agreements

By Christopher Gordon on September 17, 2025 Posted in Antitrust, FTC

What happened. On September 10, 2025, the FTC announced it sent warning letters to a number of healthcare employers and staffing firms about potentially unlawful non-compete provisions, signaling the agency’s renewed focus on labor restraints in healthcare. The letters urge recipients to reassess existing contracts and warn that the FTC may open investigations if provisions are overbroad or unfair.

Case-by-case enforcement is the plan. Just days earlier, the Commission voted 3-1 to drop its appeals and “accede to vacatur” of its nationwide Noncompete Rule, which has been enjoined since August 2024. The agency underscored that, even without a rule, it will pursue individual matters under Section 5 of the FTC Act, which prohibits “unfair methods of competition.” Expect investigations and settlements rather than a one-size-fits-all federal ban.

A fresh consent order shows the template. On September 4, 2025, the FTC ordered Gateway Services, the nation’s largest pet cremation company, to stop enforcing non-compete agreements covering roughly 1,800 workers. Although outside traditional provider settings, the case highlights the kinds of features the FTC is targeting (broad restrictions imposed on non-executive employees) and foreshadows scrutiny of similar terms in healthcare and staffing.

HRSA to Test 340B Rebate Model in Pilot Program

By Robert Nauman on September 3, 2025 Posted in 340B Program, Hospitals, Pharmaceutical

On July 31, 2025, the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA) announced the availability of a new 340B Rebate Model Pilot Program (the Rebate Pilot Program). Under this Rebate Pilot Program, instead of receiving discounts on the purchase price for certain drugs, covered entities will receive a post-purchase rebate reflecting the difference between the higher upfront cost and the drug’s 340B price. The stated purpose of the Rebate Pilot Program is to test this rebate model on a select group of drugs in a “methodical and thoughtful approach to ensure a fair and transparent 340B rebate model process for all stakeholders involved.” The program is also intended to help HRSA better understand the merits and shortcomings of a 340B rebate model from various perspectives. Initially the Rebate Pilot Program will be limited to those drugs included on the CMS Medicare Drug Price Negotiation Selected Drug List[1], but may be expanded in the future to include other drugs.

Amedisys Pays $1.1 Million for HSR Compliance Lapse Amid Pending UnitedHealth Deal

By Christopher Gordon on August 12, 2025 Posted in Antitrust, Compliance, DOJ, FTC, Mergers and Acquisitions

Amedisys, a major provider of home health and hospice care, has agreed to pay a $1.1 million civil penalty to settle allegations that it violated the Hart-Scott-Rodino (HSR) Act during the antitrust review of its pending $3.3 billion acquisition by UnitedHealth’s Optum division.

What Happened

In December 2023, while responding to a DOJ “Second Request” for information, a mandatory step in large merger reviews, Amedisys filed a sworn certification that its production was “true, correct, and complete.” In reality, the company knew that its email archiving system had malfunctioned, causing the loss of a month’s worth of emails from May–June 2023, a critical period in the merger negotiations.

Rather than flagging this gap at the time, Amedisys submitted its certification without mentioning the problem. Those missing emails could have contained substantive discussions relevant to the DOJ’s competition analysis. The company ultimately filed a corrected certification in August 2024, more than eight months later, but by then had been out of compliance for each day in between.

Food and Drug Administration (FDA) Issues Draft Guidance on Transfer of 510(k)s

By Squire Patton Boggs on June 24, 2025 Posted in FDA, Medical Device, Technology

On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position on the 510(k) requirements in the context of such transactions.

Squire Patton Boggs attorneys Nicole Bothwell, Delia Deschaine, John Wyand, Stephen Chelberg and Jennifer Tharp discuss the FDA’s new guidance in our latest Client Alert, which may be found here.

Trump Signs Executive Order to Reduce U.S. Drug Prices with “Most-favored Nation” Policy and CMS Establishes Pricing Targets

By Squire Patton Boggs on June 17, 2025 Posted in Executive Actions, Pharmaceutical

On May 12, President Trump signed an executive order entitled “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” (the “Order”). At the core of the executive order is a commitment to most-favored nation (“MFN”) pricing for drugs sold in the U.S. Under MFN pricing, Americans would pay no more for prescription drugs than the lowest prices for which those drugs are sold in other developed countries. To implement MFN pricing, the Order directs the U.S. Trade Representative and Secretary of Commerce to take steps against foreign nations that the Administration believes to be suppressing drug prices abroad in ways that unfairly shift higher costs onto American consumers. It also instructs the Administration to communicate clear pricing targets to pharmaceutical companies, reinforcing that U.S. consumers should receive the most favorable pricing. Further, it directs the Secretary of Health and Human Services to establish a mechanism through which American consumers can buy drugs directly from manufacturers rather than intermediaries. Lastly, the Order instructs the Secretary of Health and Human Services to impose MFN pricing through regulations on drug manufacturers that do not voluntarily adopt MFN pricing and to take other steps to reduce the costs of drugs for U.S. consumers.

Reconciliation Bill Provisions Targeting Tax-Exempt Organizations Affect Hospitals

By Stacey Grundman on May 29, 2025 Posted in Hospitals, Legislation, Tax

The budget reconciliation bill passed by the House of Representatives on May 22, 2025 (the “Reconciliation Bill”), contains a number of provisions targeting tax-exempt entities. While these provisions do not specifically target or call out hospitals, they may apply to tax-exempt and government hospitals.

Excise Tax on Compensation Expanded

Under current law, tax-exempt organizations and certain government entities are subject to a 21 percent excise tax on employee compensation that exceeds $1 million or that constitutes an excess parachute payment. The excise tax applies to amounts paid to the five highest compensated employees of the organization in the tax year and those who had been in that category since 2017 (“Covered Employees”).

Hospitals exempt from taxation under section 501(a) of the Internal Revenue Code of 1986 (the “Code”) and, in some cases, those owned by state or local governments are subject to this excise tax. However, compensation paid to licensed medical professionals for the performance of medical services does not count towards the $1 million trigger of the excise tax. Only the portion of a medical professional’s compensation for other services, such as research, teaching, or administrative or governance duties, are considered compensation for this purpose. Compensation paid by entities related to the tax-exempt or government entity, such as a for-profit or tax-exempt subsidiary or other affiliate, is included for this purpose.

Top 10 Key Takeaways From the UK Healthcare and Innovation Forum

By Mark Yeo, Jon Lent, David Naylor, Nicola Smith, Victoria Leigh and Nick Green on May 15, 2025 Posted in United Kingdom

On 12 March, we hosted an event in our London office where lawyers Mark Yeo, Jon Lent, David Naylor, Nicola Smith, Victoria Leigh and Nick Green discussed: decarbonisation in healthcare, healthcare with the new government with geopolitical insights, trends in healthcare M&A and HealthTech innovations.

View the top 10 takeaways affecting the industry and likely to have significant impact in the coming year.