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HHS OIG has “significant concerns” about company-sponsored speaker programs

On November 16, 2020, the U.S. Health & Human Services (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically used to signal enforcement priorities – “to highlight certain...more

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

OIG gives the green light to another innovative warranty

Last week, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 18-10, advising that the OIG would not pursue an enforcement action under the Anti-Kickback Statute (AKS)...more

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