Alexandra PearsallOn June 21, the U.S. Food and Drug Administration (FDA) finalized industry guidance pertaining to the requirements and recommendations for manufacturers, packers, and distributors when…
On April 22, 2019, the Centers for Medicare & Medicaid Services (CMS) announced five new payment model options under its “Primary Cares” initiative. The aim…
Many states have enacted any willing provider (“AWP”) laws that apply to pharmacy participation in networks. These laws require managed care plans to accept qualified…
CMS Expands Immediate Jeopardy Standards “Immediate Jeopardy” is defined by the Centers for Medicare & Medicaid Services (CMS) as “a situation in which the provider’s…
The Food and Drug Administration (FDA) recently published a Notice and Request for Comments regarding a potential proposal to impose less stringent regulations on biopharmaceutical…
The Centers for Medicare & Medicaid Services (“CMS”) recently published proposed changes to the Anti-Kickback Statute and Stark Law to address concerns that these laws…