California and Missouri are the latest states to target hemp-based products containing intoxicating cannabinoids. On Sept. 23, 2024, California signed into law emergency regulations aimed at protecting children from the...more
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more
On Oct. 7, 2023, Gov. Gavin Newsom signed the California Food Safety Act (CFSA) into law, making California the first state to ban the manufacture, sale, distribution or delivery of food products containing four food...more
On June 5, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule in the Federal Register that withdraws COVID-19 vaccination mandates for certain providers’ staff members and withdraws long-term care...more
Both the House and Senate are considering multiple bipartisan bills concerning pharmacy benefit managers (PBMs), meaning action is likely this year. However, the timeline and path forward remain unclear, since the two bodies...more
On April 25, 2023, four federal government agencies released a joint statement announcing their resolve against bias and discrimination in automated systems and artificial intelligence (AI). Together, the Consumer Financial...more
On April 20, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the release of ownership data for all Medicare-enrolled hospice and home health agencies. This release is consistent with the Department of...more
In recent weeks, the Centers for Medicare & Medicaid Services (CMS) has been contacting certain Medicare-enrolled providers and suppliers (hereinafter “providers”) to verify that their ownership information, as reported in...more
The Department of Health and Human Services’ Office for Civil Rights (OCR) announced the expiration of its enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of 1996...more
Government investigators focus on pandemic-related fraud has culminated in a recent criminal conviction As announced by the Department of Justice (DOJ), on Friday, January 13, 2023, a federal jury convicted a Colorado...more