Rebate Rule May Be Finalized Soon, But Skepticism Lingers That Trump Can Make Lasting Changes On Rx Pricing
Trump administration could also finalize international reference pricing plan, which could be riskier to industry as it's an area where Democrats and Trump have more alignment, but this proposal may be easier for industry to overturn in court than that rebate rule. A finalized rebate rule is under review by the Office of Management and Budget, but it is unclear if the coming proposal will have any teeth given the limitations imposed by the President’s summer executive order.
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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.
Trump Administration addresses concerns that the rule violates the First Amendment and exceeds its statutory authority in the final rule, which is strongly opposed by biopharma.
It’s not quite the rebate rule, but final reg aims for ‘a reduction in the use of rebates and other price concessions’ driven by the transparency requirement and broad definitions. PCMA warns that ‘mandating an increased level of disclosure for this information could result in higher prescription drug prices for consumers.’