Insights

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.

On May 28, 2025, Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz sent a letter to select hospitals requesting information about the hospitals’ practices related to treatment for gender dysphoria in children. The letter also requests financial information related to pediatric gender-affirming care paid for “in whole or in part” by the federal government.

On May 12, 2025, President Trump issued an Executive Order titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," which aims to reduce the costs of prescription drugs and biologics for American consumers and other payers. This Order revives a plan from President Trump’s first term and follows his April Executive Order, “Lowering Drug Prices by Once Again Putting Americans First,” which also sought to reduce drug prices. With drug prices in the United States nearly three times higher than many other countries, this second Order asks drug manufacturers to adopt Most-Favored-Nation (MFN) pricing for drugs sold in the United States or face potential regulation. MFN pricing would tether drug prices offered in the United States to the lower-cost prices offered in other comparably developed nations, such as Canada, Germany, or the United Kingdom.

The Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (the “Tri-Agencies”) have signaled that changes may be coming to the Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule issued on September 8, 2024. On May 9, 2025, the Tri-Agencies filed a Motion for Abeyance in a lawsuit brought by the ERISA Industry Committee (“ERIC”) challenging the 2024 final MHPAEA regulations in the United States District Court for the District of Columbia.[1] The Motion, which was granted by the Court, indicated that the Tri-Agencies intend to “reconsider” the Final Rule, including “whether to issue a notice of proposed rulemaking rescinding or modifying the Final Rule.” Yesterday, on May 15, 2025, the Tri-Agencies issued a notice of non-enforcement stating that they “will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months.”

On May 1, the NIH issued an update on its grants policy, establishing a “new award structure” that would prohibit foreign subawards from being nested under the parent grant, replacing them with direct awards linked to a prime award. Effective immediately, NIH will no longer issue awards that include a subaward to a foreign entity until the new structure is implemented. The notice did not limit this new structure for foreign recipients to any particular jurisdiction, potentially impacting a wide range of grants and limiting international collaboration with U.S. researchers through the subaward model.

On April 17, 2025, Arkansas recently became the first state to enact broad restrictions on pharmacy benefit managers (“PBMs”) owning retail pharmacies within the state.

In a landmark verdict on April 14, 2025, the U.S. Department of Justice Antitrust Division notched its first-ever jury trial conviction for criminal wage-fixing under the Sherman Act in United States v. Eduardo Lopez in the District of Nevada. A home health care staffing executive, Eduardo (“Eddie”) Lopez, was found guilty of (1) conspiring with several competing home healthcare staffing agencies to fix the wages of home health nurses in the Las Vegas area, and (2) defrauding the unwitting buyer of his agency by concealing the then-ongoing antitrust investigation into nurse wage and hiring practices. It is worth noting, however, that while the Lopez conviction is a significant milestone for the DOJ’s campaign into labor antitrust violations, wage-fixing cases may be more straightforward to prosecute than no-poach agreements, where the DOJ still has not prevailed before a jury. This victory nonetheless affirms the DOJ’s ability to criminally prosecute labor market collusion as a criminal offense after numerous failed attempts, signaling the prudence of further caution for companies and individuals to mitigate risk in labor antitrust markets.

On April 11, 2025, the U.S. Department of Justice (DOJ) issued guidance regarding the implementation and enforcement of the newly enacted final rule, “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” now referred to as the Data Security Program (DSP). The release included an Implementation and Enforcement Policy, a Compliance Guide, and Frequently Asked Questions (FAQs). Collectively, these documents are designed to help entities subject to the DSP understand and comply with the obligations set out under the Final Rule.

In its first healthcare proposed regulation, the Trump Administration, through the Centers for Medicare & Medicaid Services (CMS), displayed on March 10, 2025, a proposed rule titled, “2025 Marketplace Integrity and Affordability Proposed Rule” (the Proposed Rule), which proposes policy changes for the Health Insurance Marketplaces that impact health plans and insurers offering Affordable Care Act (ACA) coverage to consumers. Specifically, the Proposed Rule shortens the Annual Open Enrollment Period (OEP) for all individual market coverage; proposes standards related to income verification for Health Insurance Marketplaces (Marketplaces); modifies eligibility redetermination procedures; and eliminates eligibility for “Deferred Action for Childhood Arrivals” (DACA) recipients, among other provisions.  

On March 27, 2025, HHS announced a “dramatic restructuring” of its various agencies and offices in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” HHS also published a Fact Sheet.

Growing focus on antitrust enforcement at the federal level in recent years has been accompanied by a similar trend at the state level. Notably, multiple states have enacted or are considering enacting various legislative or regulatory changes that would create new regulatory requirements for businesses and make antitrust suits significantly easier for state attorneys general and private plaintiffs. These include new pre-transaction notice requirements, as well as the expansion of existing state antitrust statutes to cover more types of conduct while shifting the burden and expense of litigation from plaintiffs to defendants. In several cases, states have expressed a clear intent to increase enforcement related to the private equity and healthcare industries specifically.

On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.

FY 2024 saw continued growth in False Claims Act enforcement, with a record year for new qui tam and government-initiated actions, and the highest total recovery in three years. Enforcement of pandemic-related fraud and cybersecurity noncompliance increased, and health care, procurement, and small business fraud violations were again priority areas. A groundbreaking opinion from the District Court for the Middle District of Florida may have teed up a potentially landscape-shifting decision about the viability of the qui tam mechanism in the not too distant future. And a landmark administrative law decision at the U.S. Supreme Court may impact many FCA cases to come. Significant decisions regarding retaliation, excessive fines, the first-to-file rule, and the public disclosure bar were also handed down by courts of appeals. Crowell attorneys discuss these highlights and others in a “Feature Comment” published in The Government Contractor.

On Friday, February 21, Rep. Brett Guthrie (R-KY) and Rep. John Joyce (R-PA), the Chairman and Vice Chairman of the U.S. House Committee on Energy and Commerce, issued a Request for Information (RFI) inviting stakeholders to provide comment as the Committee explores the development of a federal data privacy and security framework. After efforts to consider a bipartisan and bicameral bill failed last year under former Chair Cathy McMorris Rodgers (R-WA), Chairman Guthrie is starting the effort anew, forming a working group with the goal of developing comprehensive legislation “that can get across the finish line.”

Federal Trade Commission Chair Andrew Ferguson announced on February 24, 2025, that the FTC will create the agency’s “first-ever” labor task force, signaling the agency’s continued focus on competition in labor markets, answering an open question from companies as to the fate of the agency’s no-poach and non-compete enforcement priorities. On February 26 Chair Ferguson followed up on his announcement with a Directive Regarding Labor Markets Task Force, providing additional details on the task force and the agency’s priorities.

California’s Assembly Bill 824 (“AB 824”) was enacted in October 2019 to curb “reverse payment” settlements among pharmaceutical companies that are used to resolve or settle patent infringement claims. The law establishes a presumption that such settlement agreements, through which a brand-name manufacturer compensates a generic manufacturer to forego its patent challenges in exchange for an agreement to enter at a later date (but before the expiration of the branded company’s patents), are anticompetitive and unlawful. AB 824 imposes significant financial penalties, with violators facing civil fines of up to three times the value received from the agreement or $20 million, whichever is greater.

The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged on the meaning of the phrase “resulting from” within the 2010 amendment to the AKS, which provided that a claim that includes items or services “resulting from” a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. The meaning of “resulting from” for purposes of establishing such FCA liability has been hotly debated by courts. The First Circuit now joins the Sixth and Eighth Circuits in adopting this stricter but-for standard, while the Third Circuit has opted for a much looser approach.

On February 18, President Trump issued an Executive Order titled “Ensuring Accountability for All Agencies” that directs independent agencies (as well as Cabinet Departments and their sub-agencies) to route all “proposed and final significant regulatory” and budgetary actions through the White House and the Office of Management and Budget. If implemented to its full extent, this action will significantly strengthen the authority of the White House by weakening the political autonomy of these independent agencies. As an assertion of the President’s inherent powers under Article II of the U.S. Constitution, it also stands to weaken congressional influence over these independent agencies, both through the appropriations and confirmation processes.

Since his inauguration on January 20, 2025, President Trump has issued a flurry of executive orders (“EOs”). Three of these EOs rescind Biden Administration guidance extending the nondiscrimination protections under Section 1557 of the Affordable Care Act (the “ACA”) to discrimination based on gender identity.[1] These protections have had a tumultuous history since Section 1557 was enacted in 2010, with each administration reversing course from the last. The new administration has reverted to the position taken in President Trump’s last presidency – that the protections against discrimination “on the basis of sex” do not apply to gender identity.

Days after President Trump issued an executive order (EO) taking aim at diversity, equity, and inclusion (DEI) programs and prohibiting federal recognition of gender identity apart from biological sex, previously issued draft guidance on diversity in clinical trials was removed from the website of the U.S. Food and Drug Administration (FDA). While the removed guidance was in draft form, it is highly unusual for FDA to revoke or alter draft guidance without issuing a statement or further guidance. This move raises questions about the applicability of statutory obligations to submit clinical trial Diversity Action Plans and the agency’s current thinking on best practices for clinical development.