False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
The State of Healthcare Enforcement
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
Work this Way: An Employment Law Video Podcast | Episode 50: Creating a Competitive Advantage Through Employee Benefits with Connor Shaw of Gallagher
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
CareYaya: A Revolutionary Approach to Elder Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more
Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more
On July 23, 2025, the president signed three AI-related Executive Orders (“E.O.s”) to accompany the recently released White House’s Artificial Intelligence (AI) Action Plan (“AI Action Plan”). These E.O.s seek to add clarity...more
The last week of June was a busy one when it comes to news about prior authorization – a major tool used by health plans and the federal government to manage healthcare utilization. The week started with a commitment from...more
In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more
Certificate of Need (CON) emerged as a central issue during West Virginia's recent legislative session, with substantial efforts to eliminate the system ultimately falling short. The CON reform has been a longstanding policy...more
On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the first of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding health care...more
Texas House Bill 3749 (HB 3749), known as "Jenifer's Law," has undergone dramatic revisions since its introduction. What began as a bill that could have shuttered many IV hydration clinics has transformed into legislation...more
On May 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule, entitled “Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole” to address a...more
From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more
After months of signaling that a new strategy was in the works, on May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) released a new strategic direction for the CMS Center for Medicare and Medicaid Innovation...more
When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more
Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more
On April 9, 2025, President Trump issued an executive order, titled “Reducing Anti-Competitive Regulatory Barriers” (the EO), directing federal agencies to identify and rescind or modify anticompetitive regulations. The EO...more
ESRD ETC among value-based care models being ended early by CMS - This decision to end the ESRD ETC payment model and several others on Dec. 31 aligns with CMS’ goal to focus on models that demonstrate potential for...more
The Center for Medicare and Medicaid Services ("CMS") has announced significant changes to its value-based payment model portfolio projected to save $750 million as part of a shift in the agency's refocused strategy toward...more
As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more
As a further update to our alert from March 27, the Trump Administration began mass layoffs at US health agencies on April 1....more
Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more
On Feb. 4, 2025, Virginia Speaker of the House Don Scott announced the creation of short-term emergency committee to address federal program cuts and layoffs. On March 8, 2025, Senate Finance and Appropriations Chairwoman...more