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Safe Harbors › Medical Devices › Physicians

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

Baker Donelson

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

Baker Donelson on

In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

Mintz - Health Care Viewpoints

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

Mintz - Health Care Viewpoints on

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

BakerHostetler

OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations

BakerHostetler on

In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic...more

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