Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

Medicare actuaries indicate the ‘most-favored nations’ plan could limit patients’ access to medicine, though CMS’ Verma says she has confidence manufacturers won’t let that happen. Loss of access, combined with expected legal challenges, may make Democrats wary of embracing the Trump team’s last-minute rule, despite general agreement on the underlying policy idea. A Part D reference pricing policy is still in the works, CMS said.

Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.