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Hospitals Safe Harbors Manufacturers

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

K&L Gates LLP on

In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...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

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