Oct 12, 2023

In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators,...

Sep 8, 2023

In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agency initiative to help create security tools to protect the US health care system from cyberattacks.

Aug 22, 2023

In this episode, Darlene Davis, Leah Richardson, and Andrew Ruskin unravel CMS’s proposed rule for the remedy for Medicare payments for drugs purchased under the 340B Program and reimbursed as hospital outpatient services. The discussion includes background of the unlawful 340B drug reimbursement policy, as well as...

Jul 12, 2023

In this episode, Alexander Chu and Ashley Davis review the end of the continuous Medicaid enrollment condition as a result of the Consolidated Appropriations Act, 2023. They discuss potential impacts of the disenrollment process for health care providers and provide helpful tips for health systems to navigate this change.

Jun 27, 2023

In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers have experienced in navigating the new regulatory flexibilities for value-based arrangements announced in 2020.