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OIG Approves Manufacturer’s Arrangement to Make Zero-Interest Financing Available to Provider Customers

USA - June 28 2022 The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), recently published a favorable Advisory Opinion, Advisory…

Meenakshi Datta, Mariah Hines, Donielle McCutcheon

OIG Approves Pharmaceutical Manufacturer-Sponsored Genetic Testing and Counseling Arrangement

USA - April 21 2022 The U.S. Department of Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion, Advisory Opinion 22-06…

Meenakshi Datta, Terrence L. George, Donielle McCutcheon

Clinical Trial Enrollment: OIG Approves Another Patient Cost-Sharing Proposal Designed to Increase Socioeconomic Diversity

USA - March 29 2022 Clinical trial enrollment continues to present challenges to sponsors seeking to identify, recruit, and enroll patients in their clinical studies. A…

Meenakshi Datta, Donielle McCutcheon

Digital Health Compliance Considerations — Revenue Models and Patient Incentives

USA - March 10 2022 The digital health market continues to grow exponentially in the United States. As startups and established companies market digital tools and…

Meenakshi Datta, Elizabeth Hardcastle, Donielle McCutcheon, Trevor L. Wear

New Flexibilities Available to Healthcare and Life Sciences Companies Under Loosened HHS-OIG Advisory Opinion Procedures

USA - January 18 2022 On January 11, 2022, the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a final rule, effective…

Meenakshi Datta, Brenna E. Jenny, Mark B. Langdon, Joseph R. LoCascio, Donielle McCutcheon