CMS 定版药品价格谈判最终规则：2029年起高价药谈判成常设框架
美国联邦医疗保险与医疗补助服务中心（CMS）11月5日发布最终规则，为高成本药品价格谈判建立常设框架。该规则为联邦医疗保险药品价格谈判计划定下自2029年生效价格起适用的政策，为参与的药厂提供更高的可预期性。
CMS 主任 Dr. Mehmet Oz 表示：「特朗普总统指示我们动用一切可用工具为美国人降低药价。这项规则为 CMS 增添了工具，帮助我们谈出更好的交易、为纳税人与受益人实现更大节省，并改善依赖联邦医疗保险处方药计划的老年人的健康结果。」按规则，CMS 将在2027年2月1日前再选出至多20种符合谈判资格的药品（涵盖 Part D 承保和／或 Part B 支付的药品），并视情况选出需要重新谈判的药品，启动第四轮谈判。
规则同时定版一项关于特定固定复方药的政策：被 CMS 认定为既有药品新剂型的复方药按既定口径处理，以免原厂借新剂型把患者转移过去、规避最高公平价格（MFP）的适用。规则还落实法律要求的小型生物技术药临时价格下限（2029与2030两个初始价格适用年），并把两项 Part D 政策写入法规：Part D 计划须把已有生效 MFP 的入选药品纳入其药品目录，计划向配药机构支付的协商价格不得高于 MFP 加配药费。
（来源：美国联邦医疗保险与医疗补助服务中心）
CMS Finalizes Drug Price Negotiation Rule: Permanent Framework for Prices Effective in 2029
The Centers for Medicare & Medicaid Services (CMS) on November 5 issued a final rule establishing a permanent framework for negotiating prices of high-cost drugs. The rule sets policies for the Medicare Drug Price Negotiation Program beginning with prices effective in 2029, providing greater predictability for participating manufacturers and supporting continued innovation.
"President Trump directed us to lower drug costs for Americans using every tool at our disposal," said CMS Administrator Dr. Mehmet Oz. "This rule provides additional tools to help CMS negotiate better deals, achieve greater savings for taxpayers and beneficiaries, and improve health outcomes for seniors who rely on the Medicare Prescription Drug Program." By February 1, 2027, CMS will select up to 20 additional negotiation-eligible drugs covered under Part D and/or payable under Part B, as well as select drugs for renegotiation, as appropriate, for the fourth cycle of negotiations.
The rule finalizes a policy on specific fixed combination drugs that CMS determines are new formulations of existing drugs, so that a manufacturer cannot shift patients to a new formulation to circumvent the maximum fair price (MFP). It also implements the Temporary Floor for Small Biotech Drugs required by law for initial price applicability years 2029 and 2030, and codifies two Part D policies: Part D plans must include selected drugs with an MFP in effect on their formularies, and the negotiated prices plans pay dispensing entities are limited to the MFP plus any dispensing fees.
(Source: Centers for Medicare & Medicaid Services)
来源：美国联邦医疗保险与医疗补助服务中心
发布：GSM·美国（发布链接）
图片来源：图：美国联邦医疗保险卡样本（2018年版式）。美国联邦医疗保险与医疗补助服务中心发布，公共领域，经 Wikimedia Commons。 / Photo: Sample U.S. Medicare card (2018 design), issued by the Centers for Medicare & Medicaid Services, public domain, via Wikimedia Commons.
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