Insights

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials” from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is currently in Step 2 of the ICH process and open for public comment until September 19, 2025.

On July 23, 2025, the Trump Administration issued an artificial intelligence (AI) action plan titled “Winning the Race: America’s AI Action Plan” (the Plan) to guide AI innovation in the U.S. The Plan includes 90 policy recommendations that will shape future AI guidance and policies impacting a range of entities and industry sectors, including health care/life sciences and entities involved in clinical research.

On June 12, 2025, the Fifth Circuit ruled in Guardian Flight I[i] and Guardian Flight II[ii] that the No Surprises Act (“NSA”) does not confer a private right of action on parties to confirm an Independent Dispute Resolution (“IDR”) award in court. The Fifth Circuit is the first United States Court of Appeals to weigh in on the issue, which has divided some district courts. On July 11, 2025 the Fifth Circuit denied Appellant’s request for en banc review of the Court’s finding that the NSA lacks a private right of action.[iii] The panel’s ruling is now final and controlling precedent for the Fifth Circuit unless overturned by the Supreme Court.

On July 4, President Trump signed into law the “One Big Beautiful Bill Act” (“the Act”), or H.R. 1, which makes significant changes to federal healthcare programs, including Medicaid, Medicare, and Health Insurance Marketplaces. As proposed in previous versions of the Act, the Act includes cuts to the Medicaid program and imposes new requirements on beneficiaries, states, and healthcare providers.

On July 2, 2025, the U.S. Department of Justice (DOJ) Civil Division and the U.S. Department of Health and Human Services (HHS) jointly announced the formation of a False Claims Act (FCA) Working Group. This new initiative underscores a coordinated federal enforcement strategy focused on identifying and addressing fraud in federally funded health care programs, particularly Medicare Advantage and Medicaid managed care. The announcement comes days after Matthew R. Galeotti, Head of DOJ’s Criminal Division, announced the results of the “largest coordinated health care fraud takedown in the history of the Department of Justice”  and the creation of a “Health Care Fraud Data Fusion Center” comprised of data specialists that will “break down information silos, using coordinated data analysis to enable our investigative teams to quickly identify and dismantle emerging fraud schemes.” Taken together, these announcements demonstrate the DOJ’s effort—in both civil and criminal divisions—to strengthen its collaboration with HHS to investigate and prosecute health care fraud.

On June 27, 2025, the Supreme Court upheld the constitutionality of the USPSTF and its role in identifying preventive services for coverage under the ACA in Kennedy v. Braidwood Management.[1]In the case, the Supreme Court considered whether the Secretary of HHS’s appointment of USPSTF members without the advice and consent of the Senate complied with the Appointments Clause in Article II of the United States Constitution. The Supreme Court found that USPSTF members were “inferior Officers” under the Appointments Clause who did not require Senate confirmation because the Secretary of HHS had the authority to remove USPSTF members at will and “to directly review and block Task Force recommendations before they take effect.” The Supreme Court therefore affirmed that the USPSTF as currently structured may legally recommend preventive services for coverage without cost-sharing requirements under the ACA.

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.”