CMS发布医保药价谈判最终规则 编号CMS-4215-F 2026年12月5日生效
美国医疗保险和医疗补助服务中心（CMS）11月5日发布最终规则（编号 CMS-4215-F），把联邦医保处方药价格谈判计划的操作指南正式写入法规，适用于2029年及以后「初始价格适用年」的谈判周期。该规则将于2026年12月5日生效。
医保药价谈判计划源于《降低通胀法》（IRA）第11001至11002条，授权联邦政府就 Medicare Part D 中支出最高的一批品牌药与药企直接谈判「最高公平价格」。此前每轮谈判的操作细节主要通过年度指南文件发布，此次最终规则将既有指南成文化，提高流程的稳定性和可预期性。
CMS 表示，最终规则明确了入选药品的确定、谈判流程、价格生效与合规监督等环节的规则文本。谈判达成的价格只适用于 Medicare 受益人，不直接改变商业保险的药品价格，但市场普遍关注其对药价体系的示范效应。
药价谈判自首轮启动以来一直是医药行业的焦点，入选药品名单、谈判降幅和对新药研发的影响备受争议。按计划，下一轮谈判将按新规则推进，CMS 后续会公布适用于2029年价格适用年的入选药品与时间表。（来源：美国医疗保险和医疗补助服务中心）
CMS Issues Final Rule CMS-4215-F Codifying Medicare Drug Price Negotiation Guidance, Effective December 5, 2026
The Centers for Medicare & Medicaid Services (CMS) on November 5 issued a final rule (CMS-4215-F) that codifies the operating guidance for the Medicare Drug Price Negotiation Program into regulation, covering negotiation cycles for initial price applicability years 2029 and beyond. The rule takes effect on December 5, 2026.
The negotiation program was created by sections 11001 and 11002 of the Inflation Reduction Act, authorizing the federal government to negotiate "maximum fair prices" directly with manufacturers for a set of high-spending brand-name drugs covered under Medicare Part D. Operational details for earlier cycles were issued mainly through annual guidance documents; the final rule now writes that guidance into the Code of Federal Regulations for greater stability and predictability.
CMS said the rule spells out how drugs are selected, how negotiations proceed, and how negotiated prices take effect and are enforced. Negotiated prices apply to Medicare beneficiaries and do not directly set commercial insurance prices, though the market watches the program for its wider signaling effect on drug pricing.
Drug price negotiation has been a focal point for the pharmaceutical industry since its first cycle, with debate over drug selection, discount levels and effects on research investment. The next negotiation cycle will proceed under the new rule, with CMS to announce selected drugs and the timeline for the 2029 price applicability year. (Source: Centers for Medicare & Medicaid Services)
来源：美国医疗保险和医疗补助服务中心
发布：GSM·美国（发布链接）
图片来源：Medicare 医保卡样本（资料图），美国医疗保险和医疗补助服务中心，公共领域
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