Judge’s Order Likely to Derail Federal Rule Clarifying 340B Drug Discount Program 2

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The Orphan Drug Imbroglio

The controversy over HRSA’s authority emerged late last year, when the agency published a legislative rule that sought to provide coverage for some uses of orphan drugs.

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A federal judge has blocked the Health Resources and Services Administration from rolling out a pilot program that would reimburse safety net hospitals that get a discount on drugs through the 340B program via a rebate, as opposed to the status quo of up-front savings. The preliminary injunction was issued on Dec. 29, just a few days before the program was slated to begin on Jan 1. 

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