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2 Anti-Kickback Developments Hold Lessons for Biopharma
February 13, 2025 | By Mary Kohler in Law360 Last year ushered in new Anti-Kickback Statute concerns for biopharma companies after...

Remarks Delivered at Public Meeting on FDA's Rare Disease Innovation Hub
October 16, 2024 Attorney Mary Kohler was invited to comment during a public meeting on FDA's plan to launch a Rare Disease Innovation...

Vertex Suit Highlights Issues for Pharma Fertility Support
September 19, 2024 | By Mary Kohler in Law360 On July 15, Vertex Pharmaceuticals Inc. sued the U.S. Department of Health and Human...

Unpacking HHS' Opinion on Cell Therapy Refund Programs
July 30, 2024 | By Mary Kohler in Law360 Cell and gene therapies grab headlines for the miracles they deliver and for their seven-digit...

Assessing HHS' Stance On Rare Disease Patient Assistance
May 13, 2024 | By Mary Kohler in Law360 It's a rainy rush hour. You're trying to navigate trucks on the freeway when your teenager...


DOJ's Biopharma Settlement Raises Anti-Kickback Questions
January 23, 2024 | By Mary Kohler in Law360 You've lost your wedding ring on the beach. Do you frantically comb the sand, or find a...


Reading Between the Lines of HHS OIG's National Lab Opinion
November 3, 2023 | By Mary Kohler in Law360 The U.S. Department of Health and Human Services' Office of Inspector General recently...

HHS Neuromonitoring Advisory May Have Broad Relevance
September 7, 2023 | By Mary Kohler in Law360 You start a wildly profitable business. Competitors flock. Some take a more aggressive...


A Glimpse Into HHS' Digital App Enforcement Priorities
July 25, 2023 | By Mary Kohler in Law360 You need to see a cardiologist. Your primary care doctor recommends two. But one's not...


Celebrating 2 Years, and What I've Learned From Mom
July 6, 2023 July 4 brought Fun & Fireworks on the firm’s deck to celebrate 2 big birthdays 🎂 . Kohler Health Law finished its second...

Schutte Ruling Shifts Risk Calculus For Compliance Officers
June 22, 2023 | By Mary Kohler in Bloomberg Law Attorney Mary Kohler explores practical considerations for business leaders,...


DOJ Incentives Pilot Takes Carrot-Stick Approach to Compliance
May 8, 2023 | By Mary Kohler in Bloomberg Law Attorney Mary Kohler analyzes the DOJ’s financial incentives and clawbacks pilot, and...


Guidance on Patient Assistance Programs Needs Careful Review
April 5, 2023 | By Mary Kohler in Bloomberg Law Health-care attorney Mary Kohler explains the intricacies of federal law and...


OIG Lays Out Risks for Continuing Education Funding
July 14, 2022 | By Mary Kohler The US Department of Health and Human Services, Office of Inspector General (OIG) recently posted...


Kohler Health Law has officially launched
May 18, 2022 I’m delighted to announce the official launch of Kohler Health Law. After a quiet start in late 2021, the firm’s website is...


Health Cos. Could See More Conference Enforcement Risk
April 20, 2022 | By Mary Kohler in Law360 Medical conferences fuel the development of new therapies. Research professionals share...

Social Media Endorsements Can’t Escape FTC’s Watch
Nov. 9, 2021 | By Mary Kohler in Bloomberg Law The FTC recently sent 700 retailers and advertisers a letter alerting them to...
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