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State Scrutiny of Hemp Cannabinoids: California and Missouri Issue Bans on Intoxicating Hemp Products

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

Medical Device Legal News with Sam Bernstein: Episode 19 [Video]

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

Medical Device Legal News with Sam Bernstein: Episode 18 [Video]

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

California Bans Four Common Food Additives and 26 Chemicals Used in Cosmetics

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

CMS Ends COVID-19 Vaccine Mandate for Medicare- and Medicaid-Certified Providers and Suppliers

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

U.S. House and Senate Committees Move Legislation to Reform Pharmacy Benefit Managers

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

Government Agencies Join Forces Against Bias and Discrimination in AI

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

CMS Publicly Releases Ownership Data for Medicare-Certified Hospice and Home Health Agencies

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

Outdated Medicare Enrollment Data? Caution: CMS Verifying Ownership

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

HIPAA Enforcement Discretion Ends When Public Health Emergency Expires on May 11

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

Medicare Accelerated Payment Fraud Leads to Criminal Conviction

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

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