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)
The Office for Civil Rights (OCR) will be ready to enforce the 2024 Part 2 Final Rule by the February 16, 2026, compliance deadline now that the U.S. Department of Health & Human Services (HHS) has delegated enforcement...more
On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more
News Briefs - Study Raises Concerns Around Doctors Becoming Too Reliant on AI - Artificial intelligence is beginning to help doctors screen patients for several routine diseases. But a new study raises concerns about whether...more
After a month-long recess, Congress has returned and is facing a deadline of September 30, 2025, to fund the government for fiscal year (FY) 2026. Both the House and Senate will only be in session for 14 days (including...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
On August 21, 2025, HHS OIG published a Data Brief, Report No. A-04-24-03003, which analyzed the frequency and outcomes for Medicare enrollees who chose to leave acute-care hospitals against medical advice (“AMA”). OIG found...more
As the page turned on 2025, optimism was high among life sciences dealmakers. Elections in the U.S. and other major economies had concluded, interest rates were poised to come in to focus, and the regulatory environment...more
Healthcare remains a key area of focus for antitrust regulators in the first six months of the Trump administration. The Federal Trade Commission (FTC) and the Department of Justice (DOJ) have for the most part stuck to prior...more
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more
On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...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
On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more
The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more
I. Overview of Telehealth and Tele-Prescribing Landscape Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities...more
The Legislation combines spending and policy priorities from 11 congressional committees and will reshape federal policy across nearly every sector of the U.S. economy. With respect to healthcare, more than 35 provisions...more
The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more
On August 4, 2025, CMS issued a final rule (Final Rule) updating payment rates, policies, and quality programs for Skilled Nursing Facilities (SNFs) under the Medicare Prospective Payment System (SNF PPS) for Fiscal Year (FY)...more
On July 24, 2025, the OIG released reports evaluating the prevalence of patient harm in hospitals and the extent to which hospitals detect and report such events. These evaluations follow up on OIG’s 2022 report and provide...more
Welcome to our eighth issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the rural health "slush fund" included in the Federal budget bill, the effect of Medicaid...more