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Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models

On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added...more

FDA Issues Draft Guidance on Providing Health Care Providers With Scientific Information on Unapproved Uses of Approved/Cleared...

On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more

Medical Device Legal News with Sam Bernstein: Episode 14 [Video]

A DMEPOS supplier agrees to pay $29M to resolve False Claims Act allegations that it billed Medicare, MA Plans, and beneficiaries for oxygen equipment for which it had already received payment in full; the FDA releases...more

New York Pharmacy Owners Indicted for Alleged Healthcare Fraud Scheme

On May 2, 2023, the U.S. Department of Justice (DOJ) announced the indictment of two New York state pharmacy owners, Taesung Kim and Dacheng Lu, for their participation in an alleged $29 million healthcare fraud scheme. Kim...more

OIG Issues Special Fraud Alert That Challenges Industry Norms Regarding Speakers Programs

On Nov. 16, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a special fraud alert addressing fraud and abuse concerns with speakers programs conducted by pharmaceutical...more

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