联邦医保中心定版器官采购组织新规：逾10万人在等移植，表现不合格机构可被立即取消认证
美国卫生与公众服务部通过联邦医疗保险与医疗补助服务中心（CMS）10月30日定版一项新规，加强对器官采购组织（OPO）的监管，让更多捐赠器官能送达等待移植的患者。OPO 负责取得捐赠授权、获取器官，并协调把器官安全、及时送往移植项目。CMS 介绍，2025年全美完成逾4.9万例移植，但目前仍有逾10万名美国人在等待能救命的移植。
新规允许表现优秀的 OPO 竞争多个捐赠服务区，厘清重新认证程序，并强化既有的流程绩效标准。新规还确立了一家 OPO 接替另一家时的明确要求，加强对不安全做法的监管；同时调整移植绩效的计算方式：仅用于胰岛细胞研究的胰腺不再计入移植数，使 OPO 的移植绩效分数反映真正移植到患者体内的器官。
具体条款包括：界定「不健全的医疗做法」，明确 CMS 可在何种情况下动用既有权力立即取消违规 OPO 的认证以保护患者；要求 OPO 更清楚地识别、调查与预防不良事件；捐赠者的胰腺若仅用于胰岛细胞研究，仍计入捐赠率，但不再计入移植率；OPO 必须追踪记录送往研究的器官的去向；OPO 医疗主任必须在该组织服务的至少一个州或领地持有执照；明确取消认证的路径，并把 CMS 主任对听证官决定的裁量复核程序成文化、更新申诉时限。服务区交接方面，离任 OPO 必须与接任者合作，接任者须提交过渡计划并定期汇报进展，以保证器官捐赠业务不中断。新规还删除了一项把认证资格限于2002至2005年间获重新认证组织的旧要求。
「每一份捐赠的器官都带着拯救一条生命的机会。」卫生与公众服务部部长小罗伯特·F·肯尼迪说，「在特朗普总统领导下，我们要让不合格的组织承担责任，加强对患者的保障，并帮助表现优秀的组织惠及更多患者。」
CMS 主任梅赫梅特·奥兹（Dr. Mehmet Oz）表示：「等待救命移植的美国人承受不起 OPO 的糟糕表现，CMS 致力于让这些组织承担责任。」他说，新规在第一届特朗普政府器官采购改革的成功基础上推进，促进更清晰的记录、更高的捐赠率，并对不良行为者施以更迅速的后果。
CMS 介绍，自2020年该机构发布设定透明、客观绩效指标的 OPO 规则以来，全国器官捐赠量已增长36%，移植量增长30%，表现最差的 OPO 数量持续下降。这项定版规则与卫生与公众服务部近日发布的国家肾脏护理计划相配套。
来源：GSM·美国
CMS Finalizes Organ Procurement Organization Rule as More Than 100,000 Americans Wait for Transplants
The U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), on October 30 finalized a rule to help more donated organs reach patients by strengthening oversight of Organ Procurement Organizations (OPOs), which secure authorization for donations, recover organs, and coordinate safe, timely delivery for transplantation. While more than 49,000 transplants were performed in the United States in 2025, over 100,000 Americans are waiting for lifesaving transplants, CMS said.
To improve access, the final rule allows high-performing OPOs to compete for multiple donation service areas, clarifies OPO recertification procedures, and reinforces longstanding process performance standards. It establishes clear requirements when one OPO takes over from another, strengthens oversight of unsafe practices, and changes how CMS measures transplant performance so that pancreata used only for islet cell research do not count as transplants, ensuring performance scores reflect organs transplanted into patients.
Key provisions define "unsound medical practices" to clarify when CMS may use its existing authority to immediately decertify a noncompliant OPO to protect patients; give OPOs clearer guidance to spot, investigate, and prevent adverse events; keep a donor whose pancreas is procured only for islet cell research counting toward the donation rate while removing such pancreata from the transplantation rate; require OPOs to track and record what happens to organs sent for research; require an OPO's medical director to hold a license in at least one state or territory the OPO serves; spell out decertification pathways; and codify discretionary review by the CMS Administrator of hearing officer decisions, with updated appeals timeframes. Outgoing OPOs must cooperate with incoming ones, which must submit transition plans with progress updates. The rule also removes a requirement limiting certification to OPOs recertified between 2002 and 2005.
"Every donated organ carries the chance to save a life," said HHS Secretary Robert F. Kennedy, Jr. "Under President Trump's leadership, we are holding failing organizations accountable, strengthening patient safeguards, and helping high-performing organizations reach more patients."
"Americans waiting for lifesaving transplants cannot afford poor performance by OPOs, and CMS is committed to holding these organizations accountable," said CMS Administrator Dr. Mehmet Oz, adding that the rule builds on the first Trump Administration's organ procurement reforms to promote clearer documentation, higher donation rates, and swifter consequences for bad actors.
Since CMS issued its 2020 OPO rule establishing transparent, objective performance measures, organ donations have increased by 36% nationwide and transplants by 30%, while the number of lowest-performing OPOs continues to decline, the agency said. The final rule complements HHS' recently released Kidney Care National Plan.
Source: GSM · USA
来源：GSM·美国（原文链接）
图片来源：图：美国卫生与公众服务部总部休伯特·汉弗莱大楼（素材库 federal-core 固定图）。ajay_suresh 摄，CC BY 2.0，经 Wikimedia Commons。 / The Hubert H. Humphrey Building, headquarters of the U.S. Department of Health and Human Services (GSM asset library, federal-core pack). Photo by ajay_suresh, CC BY 2.0, via Wikimedia Commons.
