HCCA 2019 Boston Regional Conference

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...

In November 2020, Alicia Siani co-authored with C. James Watson, James D. Whitledge, and Michele M. Burns "Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors," published in Journal of Medical...

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory...

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services ( CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...