Moving Beyond the Usual Helpline Data
Episode 381 -- NAVEX's 2025 Annual Hotline Report
CSC Guidance Unveiled: NIL Enforcement and Implications for Collectives — Highway to NIL Podcast
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
New Virginia "Workplace Violence" Definition and Healthcare Reporting Law: What's the Tea in L&E?
What the One Big Beautiful Bill Act Means for Employers - #WorkforceWednesday® - Employment Law This Week®
Understanding the New Overtime Tax Policies in the Big Beautiful Bill
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
(Podcast) California Employment News: Creating the Report for a Workplace Investigation – Part 4 (Featured)
California Employment News: Creating the Report for a Workplace Investigation – Part 4 (Featured)
Podcast - Navigating the Updated SF-328 Form
Five Tips for a New Public Company Director
Compliance Tip of the Day: Internal Control Deficiencies
Daily Compliance News: July 7, 2025 the Disaster on the River Edition
First 100 Days of the New HSR Rules with Antitrust Partner Kara Kuritz
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: What is a Gap Analysis
Compliance into the Weeds: Autonomous AI Whistleblowing Misconduct
REFRESH Nonprofit Basics: Federal Tax Filing Deadlines and Penalties
(Podcast) California Employment News: Back to the Basics of Employee Pay Days
On August 20, 2025, the Alabama Board of Pharmacy (the “Board”) issued its long-awaited non-disciplinary penalty schedule via emergency rulemaking. The rule went into effect immediately and will expire on December 18, 2025....more
On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more
The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more
On May 6, 2025, Indiana Governor Mike Braun signed Indiana HB 1666 into law. This new law grants Indiana’s attorney general authority to investigate market concentration of health care entities, modifies existing requirements...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
On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more
On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more
Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more
We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more
On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more
On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last...more
On December 30, 2024, the Massachusetts Legislature passed House No. 4653, “An Act Enhancing the Health Care Market Review Process.” This bill includes sweeping changes focused on increased regulatory oversight and healthcare...more
Following the release of a memo last month detailing upcoming regulations, the Massachusetts Board of Registration in Pharmacy released its long-awaited regulatory changes for non-resident pharmacy licensure last week by...more
A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more
New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more
Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more
The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more