Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?
The movement toward a value-based healthcare system has created new care models focused on paying for outcomes and clinical improvements. Olsson Frank is at the forefront of these changes, working with both healthcare providers and suppliers interested in introducing, testing and successfully participating in new care arrangements. Our lawyers have experience working at the Center for Medicare and Medicaid Innovation (CMMI), the Centers for Medicare & Medicaid Services (CMS), and as agency counsel in roles promoting these reforms. In addition, our team is focused on the intersection of these value-based models and new reforms to existing fraud and abuse laws, like the Stark Law and Anti-Kickback Statue, to create new opportunities and remove barriers to care coordination.