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Enforcement Actions › Civil Monetary Penalty › Safe Harbors

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

Buchalter

CFPB Further Defines Abusiveness Standard; Expresses Intent to Limit Duplicative Enforcement

Buchalter on

In a Policy Statement effective on January 24, 2020, the CFPB addresses perceived uncertainty as to the scope and meaning of the abusiveness standard, and that the CFPB had in various enforcement actions asserted claims for...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

Mintz - Consumer Product Safety Viewpoints

California Prop 65: More Unintended Consequences

Mintz - Consumer Product Safety Viewpoints on

Last month, the California Office of Environmental Health Hazard Assessment (“OEHHA”) adopted new Proposition 65 warning regulations. Much of the discussions regarding these new regulations have centered on the warning...more

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