On March 12, 2025, in one of the Trump Administration’s first actions with respect to the Center for Medicare and Medicaid Innovation (CMMI), CMMI announced that it would prematurely terminate four alternative payment model...more
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more
Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more
The Senate Finance Committee chronic care working group recently released a Policy Options Document continuing an effort that started with a hearing titled, “Chronic Illness: Addressing Patients’ Unmet Needs” in the summer of...more
Last week, as the Affordable Care Act turned three, the drumbeat of concern over Medicare Advantage cuts grew louder when Senate Finance Committee Chairman Max Baucus and Ranking Member Orrin Hatch – as well as 98 house...more