Insights

Boston – October 15, 2025: Jeffrey S. Gleason, an accomplished first-chair trial attorney and former leader in the Civil Fraud Section of the U.S. Department of Justice, has joined Crowell & Moring as a partner, further bolstering the firm’s fast-growing and industry-leading Health Care Group.

Washington – September 24, 2025: Crowell & Moring today announced the arrival of two seasoned attorneys, Rachel Park and Jill Abrams, to its nationally recognized Health Care Group. Both join Crowell after more than two decades at the Department of Health and Human Services (HHS), where they served in various senior level positions across the department. The addition of Park and Abrams further strengthens the firm’s ability to advise sophisticated health care clients on complex regulatory, compliance, enforcement, and litigation matters. They join the firm as senior counsel in Washington, D.C.

On April 10, 2026, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (2026 CMS Interoperability Standards and Prior Authorization for Drugs, or CMS-0062-P) outlining the agency’s plans to impose new interoperability requirements on payors participating in certain Medicare and Medicaid programs. As described by the agency in a recent press release, the proposed rule “builds on” prior rulemaking by clarifying and enhancing interoperability requirements for payors’ prior authorization processes, specifically those associated with coverage requests for pharmaceutical therapies.

In mid-April, a bipartisan coalition of 45 State Attorneys General (AG) submitted a formal letter to the U.S. Department of Labor (DOL) expressing their collective support for a proposed rule (Improving Transparency into Pharmacy Benefit Manager Fee Disclosure, or RIN 1210-AB37), which would — if enacted — impose new disclosure obligations on pharmacy benefit managers (PBM) regulated under the Employee Retirement Income Security Act of 1974 (ERISA).

In keeping with ongoing efforts to intensify regulatory oversight of organ procurement organizations (OPOs) and curtail improper spending within federal health programs, the Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule that would, among other adjustments, align Medicare payment policies for non-renal organs to be consistent with those currently applicable to kidneys. If enacted as drafted, this latest rule could have a direct impact on the financial stability of OPOs and histocompatibility laboratories (HCL) at a time when such organizations face increasing pressure to meet CMS’s new outcome measures — or else face non-renewal or decertification later this year. 

Join us for an interactive and educational event tailored for biotech leaders seeking to ensure security compliance while leveraging the power of Amazon Web Services (AWS). This session will dive into the critical elements of designing secure, scalable, and compliant systems for biotech operations, from research and development to clinical trials and beyond.

The landscape of AI governance and regulation is shifting. Following the release of the White House’s “America’s AI Action Plan” in July 2025 and the President’s signing of related Executive Orders, the White House has emphasized (at least rhetorically) a preference for innovation, adoption, and deregulation. But that does not tell the entire story. The Administration remains committed to exercising a heavy hand in AI, including by banning the U.S. government’s procurement of so-called “woke AI,” intervening in the development of data centers and the export of the AI technology stack, imposing an export fee for certain semiconductors to China, and assuming a stake in a U.S. semiconductor company. State legislatures are also racing to implement their own regulations, particularly around AI’s use in critical areas, such as healthcare, labor and employment, and data privacy. The many sources of regulation raise the specter of a fragmented compliance environment for businesses. This webinar will delve into the Administration’s AI strategy, going beyond the headlines to analyze:

On October 16, 2025, Partner Matthew F. Ferraro, Partner and CHS Managing Director Jason Johnson, and Counsels Jacob Canter and Anna Z. Saber hosted a webinar on the shifting dimensions of AI governance and regulation. They discussed federal policy, state laws, international efforts, and key court cases and how these many sources of regulation serve to fragment the AI compliance environment for businesses and how firms can respond. Click here to view the webinar on demand.

This podcast episode features the following speakers:

Click below to listen or access from one of these links: PodBean | SoundCloud | iTunes

In this episode, hosts Payal Nanavati and Megan Beaver speak with Linda Malek and Matthew F. Ferraro about the latest federal and state developments in artificial intelligence (AI) policy affecting health care. The conversation covers the Trump administration’s AI action plan and Executive Orders on AI, new industry-specific and comprehensive state laws, and enforcement trends, with a focus on how these changes impact the health care industry.