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New Kickback Safe Harbor for Federally Qualified Health Centers

Client Alert | less than 1 min read | 07.01.05

The HHS Office of Inspector General has issued a proposed new anti-kickback law safe harbor protecting transfers of goods, items, services, donations and loans to federally qualified health centers if specific conditions are met. The proposed regulation implements a provision of the Medicare Modernization Act calling for the new safe harbor where an arrangement contributes meaningfully to the health center's provision of services to a medically underserved population.  The comment period on the proposed regulation runs until August 1, 2005. Click here to view the proposed rules published in the Federal Register.

Insights

Client Alert | 15 min read | 08.20.25

The New EU “Pharma Package”: Interplay with the Critical Medicines Act and other shortage initiatives

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy....