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Healthcare Fraud Safe Harbors Medical Devices

Knobbe Martens

Application of Safe Harbor Exceptions to the Anti-kickback Statute

Knobbe Martens on

On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical...more

ArentFox Schiff

Understanding OIG Advisory Opinion 25-09: Compliance Guidelines for Physician-Owned Medical Device Companies

ArentFox Schiff on

On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs)....more

Bass, Berry & Sims PLC

The Philosophy for Investing in Urology: 5 Key Regulatory Risks

Bass, Berry & Sims PLC on

In the wave of physician practice management transactions, urology is poised to be one of the next hot sectors. In addition to the issues to consider in connection with any physician practice transaction, below we discuss...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

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