From: Health Affairs Blog
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Finally, CMS’ boldest action to date might come in a proposed rule currently under review at the Office of Information and Regulatory Affairs. The rule proposes to eliminate the current safe harbor protection for pharmaceutical rebates under the anti-kickback statute and to create a new safe harbor. Without more information, it is not known how important this proposal will be, and many procedural steps (and therefore many months) remain before such a rule could be finalized. (Incidentally, MA plans often rely on pharmacy benefit managers (PBMs) to help control their Part B spending, so although the administration may seek to limit the power of PBMs with this proposed rule, the step therapy announcement doubles down on their importance.)