The risen-from-the-ashes HHS final rule eliminating the anti-kickback safe harbor for manufacturer rebates on prescription drugs was finally released 20 November. It includes some modifications of the proposed version but no new data or analyses supporting US HHS Secretary Alex Azar’s position that the rule will not backfire by significantly increasing plan premiums and federal spending. That raises significant questions about its future.
The rebate rule was announced during a White House event along with an interim final rule much more worrisome to biopharma that would enable the government to test a new...