特朗普总统曾扬言迫使药企向联邦医疗保险提供全球最低价格,如今这一标志性威胁却以雷声大雨点小的方式收场。相关监管规定预计只会影响少数几家药企。但问题是:这一价格试验可能带来影响深远的法律后果。
President Trump's signature threat to force drugmakers into offering Medicare the lowest prices in the world has ended in a whimper, with a regulation that's expected to impact just a handful of manufacturers. Yes, but: The legal ramifications of the pricing experiment could be far-reaching. Why it matters: The policy's fate could fuel future battles over drug price controls, and whether Medicare administrators have the power to overhaul the program's laws.
为何重要:这项政策的命运可能引发未来围绕药品价格管制的争斗,以及联邦医疗保险管理人员是否有权彻底改革该项目的法律框架。
Driving the news: The Centers for Medicare and Medicaid Services this week finalized plans for a five-year program that would peg what the government pays for certain physician-administered drugs to prices in other developed countries.
新闻缘由:联邦医疗保险与医疗补助服务中心本周敲定了一项五年期计划,将政府为某些由医生施用的药品支付的价格与其他发达国家的价格挂钩。
The idea is similar in spirit to the Trump administration's "most favored nation" drug pricing deals, but in the eyes of some critics was less a pilot program than a wholesale policy change.
这一理念与特朗普政府的“最惠国”药品定价协议大致相似,但在一些批评者看来,它与其说是一项试点计划,不如说是一场全面政策变革。如果药企收取的价格高于国际基准,就必须向联邦政府支付返利。
Drugmakers would pay rebates to the federal government if they charge more than an international benchmark. The plan would cover a randomly selected group of about 25% of beneficiaries with original Medicare Part B as their primary coverage, whose out-of-pocket costs would also be tied to the international benchmark.
该计划将涵盖随机抽取的约25%的受益人,这些人以传统联邦医疗保险B部分作为主要保障,其自付费用也将与国际基准挂钩。
Reality check: The scope of the program that the administration outlined this week is much narrower than what it originally proposed and would deliver a fraction of the originally envisioned savings.
现实情况:政府本周公布的计划范围远小于最初提出的方案,节省金额也只会达到最初设想的一小部分。预计已经与特朗普达成“最惠国”定价协议的药企将获得豁免。
It's expected to exempt drug companies that already struck MFN pricing deals with Trump. "Orphan" drugs for rare diseases, certain cell and gene therapies, plasma-derived products and biosimilars and their reference biological products also are excluded.
用于治疗罕见病的“孤儿药”、某些细胞和基因疗法、血浆衍生产品、生物类似药及其参照生物制品也不在计划覆盖范围内。被选中参与联邦医疗保险药品价格谈判的药物同样被排除在外。
So are drugs selected for Medicare drug-price negotiation. All told, the projected savings would be $440 million over five years, compared with the $11.9 billion in last year's proposal. (CMS says total Part B drug spending was $81.9 billion, based on 2025 claims data.)
总体而言,预计五年内可节省4.4亿美元,而去年提案中的金额为119亿美元。(CMS称,根据2025年理赔数据,联邦医疗保险B部分的药品总支出为819亿美元。)政府表示,该计划与降低美国民众药价的持续努力相辅相成,重点针对由联邦医疗保险B部分支付、且主要在医院门诊或医生诊所内使用的日益昂贵的药品。
The administration says the program dovetails with its ongoing efforts to reduce drug costs for Americans and takes aim at increasingly expensive drugs paid for by Medicare Part B that are delivered primarily in a doctor's office or outpatient department. "We're taking action to pilot a new approach to lower costs and strengthen the quality of care while preserving medical innovation," CMS administrator Mehmet Oz said in a statement. But policy analysts portrayed the outcome as a short-term win for pharma:
CMS负责人mehmet·奥兹在一份声明中表示:“我们正在采取行动,试点一种新方法,在维护医疗创新的同时降低成本、提高医疗质量。”但政策分析人士认为,这一结果对制药行业而言只是短期利好:Capital Alpha分析师罗布·史密斯在一份报告中写道:“即使在这么长的时间内节省119亿美元,金额也相当有限,而4.4亿美元更是微乎其微,这很可能意味着该措施只会适用于范围极窄的一部分产品。”
"Even $11.9 billion in drug savings is fairly paltry over that amount of time, but $440 million is microscopic and likely means application would be limited to an extremely narrow band of products," Capital Alpha analyst Rob Smith wrote in a note. The waivers and product exclusions mean there may be fewer than five companies impacted by the payment model, according to Raymond James analyst Chris Meekins.
Raymond James分析师克里斯·米金斯表示,豁免条款和产品排除条款意味着可能受到这一支付模式影响的公司不足五家。
"It is understandable why there was no big White House announcement of the model.
米金斯在一份报告中写道:“可以理解白宫为何没有大张旗鼓地宣布这一模式。CMS大幅缩小了这次试点的覆盖范围。”
CMS substantially narrowed its reach in this demo," Meekins wrote in a note.
政府周三发布的最终规则出台前,针对这项名为“全球高效药物定价基准模式”的计划已经引发了数月的激烈争议。
The final rule the administration released Wednesday came after months of rancor over the plan, known as the Global Benchmark for Efficient Drug Pricing Model.
最初的提案遭到了立场各异的不同团体批评,其中既有保守派纳税人组织,认为政府利用价格管制手段越权,也有根据联邦医疗保险B部分提供癌症治疗服务的肿瘤科医疗机构和医院。患者权益组织也认为,该计划可能会扰乱医疗服务。
The original proposal drew criticism from an unusual assortment of groups — from conservative taxpayer organizations, which argued the administration was overreaching with price controls, to oncology providers and hospitals that administer cancer therapies under Medicare Part B. Patient advocacy groups also argued the plan could disrupt care.
从字里行间可以看出,分析人士警告称,将药品制造商的回扣与其产品在海外的价格挂钩可能引发法律诉讼,该计划的合法性或将受到挑战。
Between the lines: The industry may sue over the legality of linking manufacturers' rebates to foreign prices, analysts warned.
米金斯表示,如果法院维持该方案,将为实施其他Medicare药品价格实验提供更有力的依据,其中包括针对D部分处方药的实验。
Meekins said if courts uphold the plan, it would strengthen the case for implementing other Medicare drug price experiments, including for Part D prescription drugs.
这也可能是一场更广泛法律争夺战的序幕,争议焦点是Medicare在试点项目上能做什么、不能做什么。
It could also be the prelude to a legal fight over what Medicare can — and can't — do with pilot programs more broadly.
值得关注的是:如果不受到法律挑战,这项缩减规模的实验将于2027年初生效。
What we're watching: The scaled-back experiment takes effect at the beginning of 2027, absent legal challenges.
与此同时,分析师预计,这项努力对药企未来收益的影响微乎其微。
In the meantime, analysts are projecting the effort will have little impact on drugmakers' future earnings.