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
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On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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