July 16th, 2024

July 16th, 2024

Orrick Grows Life Sciences & HealthTech Platform with 7-Lawyer FDA and Healthcare Regulatory Team

The global law firm – 奥睿 - has expanded its Life Sciences & HealthTech platform by adding three regulatory partners. Georgia Ravitz, formerly head of the FDA regulatory practice at Wilson Sonsini, joins in Washington, D.C., focusing on food and drug law and regulatory policy. Amy Joseph and Jeremy Sherer , who come from the national healthcare boutique law firm Hooper, Lundy & Bookman, P.C. in Boston, advise healthcare industry stakeholders on regulatory compliance, digital health, and AI utilization. With these additions, Orrick’s platform has grown to 53 partners, serving over 600 life sciences, healthtech, and digital health clients. The firm aims to provide destination-quality regulatory solutions for innovative clients in this sector. Link: https://bit.ly/3Y5jE2q

Media Shines Spotlight On Urinary Catheter Fraud

Jeffrey Baird from Brown & Fortunato discusses how, despite Medicare's massive budget, it faces persistent challenges from fraudulent claims, particularly in the durable medical equipment (DME) sector. Recent scrutiny and regulatory actions have targeted fraudulent schemes involving products like urinary catheters, where companies have allegedly billed for unnecessary supplies using Medicare beneficiary and physician information. This has prompted calls for enhanced industry self-policing mechanisms, such as dedicated fraud hotlines or interactive websites, to proactively identify and report fraudulent activities before they escalate, thereby improving industry credibility and regulatory compliance.

Link: https://bit.ly/4d1AT8R

Healthcare Founders Face New Exit Considerations

Hal Katz from Husch Blackwell discusses how exiting a business, whether as a serial entrepreneur moving on or a healthcare provider with decades of investment, is daunting due to the intricate nature of corporate transactions and the emotional attachment involved. Despite a historically robust market fueled by substantial private equity investment, post-pandemic challenges like high interest rates and increased regulatory scrutiny have slowed deal activity. State and federal scrutiny, including new reporting requirements and antitrust inquiries into smaller transactions, have intensified, impacting deal timelines and complexity. However, despite these obstacles, strategic preparation and negotiation can facilitate successful exits, especially when aligning seller goals with buyer expectations and utilizing structures like earnouts to bridge valuation gaps. Link: https://bit.ly/3S4LDLG

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