Drug Price Transparency Rule Tees Up Constitutional Concerns
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.
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Either through the courts or a postponement by the Trump administration itself, the Medicare Part B rule seems destined to remain dormant instead of going into effect in January as scheduled.
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.
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.’