The risen-from-the-ashes HHS final rule eliminating the anti-kickback safe harbor for manufacturer rebates on prescription drugs was finally released 20 November. It includes some modifications of the proposed version but no new data or analyses supporting US HHS Secretary Alex Azar’s position that the rule will not backfire by significantly increasing plan premiums and federal spending. That raises significant questions about its future.
Medicare Part D Drug Rebate Rule Finally Sees Light Of Day: Now What?
Assurances from HHS Secretary Azar that rule will not significantly raise premiums and federal spending amount to a request to ‘just trust me.’
More from Pricing Debate
• By
A Republican think tank suggested variations of the Most Favored Nation and international reference policies in Medicare and Medicaid, as well as tariffs and other trade levers to rebalance drug pricing disparities between US countries and abroad.
• By
Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.
• By
The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
• By
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
More from Market Access
• By
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
• By
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
• By
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.