With the introduction of the IRA, a question has loomed about whether CMS will follow an explicit or implied value framework to inform its price negotiations. The revised program guidance has clearly signaled that CMS will consider a broad range of evidence as part its initial price offer. In our view, CMS, in its early actions to explain the evidence they will consider in the drug negotiation process, has taken important steps in establishing a national value framework for the largest federal healthcare prescription drug program in the United States.
