卫生与公众服务部发布肾脏护理国家计划:覆盖约3,700万患者 推早期检测与移植改革

美国卫生与公众服务部(HHS)10月20日在华盛顿宣布推出「肾脏护理国家计划」(Kidney Care National Plan),这是一项覆盖全部门的协调战略,旨在振兴美国的肾脏护理。该计划隶属「让美国再次健康」(Make America Healthy Again)倡议,将针对疾病根源,改善肾病各个阶段的治疗,并明确联邦政府可以在哪些环节采取行动:改善肾病全程护理、消除阻碍创新的监管壁垒、维护运转良好的肾脏护理市场,让患者有更多选择、获得更好疗效。
卫生与公众服务部长 Robert F. Kennedy, Jr. 表示:「特朗普总统2019年就挑战了那套等到患者发展成肾衰竭才出手的体系。如今 HHS 在此基础上更进一步:更早发现肾病、扩大治疗与居家护理选择、清除创新与移植的障碍、强化整个移植系统的安全。我们的目标很简单:保住肾脏健康、给患者更多选择,帮助更多美国人避免肾衰竭、活得更久更健康。」
据 HHS 介绍,肾病是美国最常见的慢性病之一,估计约有3,700万美国成年人患病,但多数患者并不知情,治疗往往在肾脏已受显著损伤后才开始;这种延误限制了延缓病情进展的机会,使患者只能依赖终身透析或肾移植。特朗普总统2019年签署里程碑式的《推进美国肾脏健康》行政令,确立了预防肾衰竭、扩大患者选择、增加移植可及性的联邦愿景;2026年这份国家计划在此基础上展开。
计划确立三大优先方向:一是预防肾衰竭——更早发现肾病、更早干预,推进能减缓或阻止病情进展的疗法与技术;二是改善透析护理并扩大患者选择——促进竞争、降低新机构与新疗法的准入门槛、扩大居家护理、支持改善疗效与生活质量的创新;三是改革移植系统——强化全系统的安全、透明与问责,同时扩大活体与逝者捐献移植的可及性。作为计划支柱之一,HHS 将推进一项全国移植扩展战略,让活体捐献更简便、更可及。
联邦医疗保险与医疗补助服务中心(CMS)主任 Mehmet Oz 表示:「要让美国再次健康,我们必须在慢性病变得灾难性之前就直面它——肾病就是一个明显的例子。太多美国人是在严重损伤已经发生后才被确诊,而我们的体系往往等到肾衰竭才行动、而不是更早出手。」他表示,该计划把预防放在首位,并将继续清除不必要的障碍、追究体系的护理责任。
HHS 同日还列出已在推进的工作:过去12个月,食品药品监管局(FDA)批准了多项严重肾病新疗法,包括首个针对局灶节段性肾小球硬化部分患者的获批治疗、首个可减少蛋白尿的补体3肾小球病成人治疗,以及免疫球蛋白A肾病与特发性肾病综合征的新疗法;卫生部通过 KidneyX 奖金竞赛投入最高467万美元,与美国肾脏病学会(ASN)合作推进心血管—肾脏—代谢风险的早期识别与护理;卫生部规划与评估助理部长办公室(ASPE)同日发布的分析显示,2019年行政令之后肾移植增长加快,该政策与每年约2,000例额外肾移植相关联,预计到2040年经济效益可达2,000亿美元。此外,HRSA 已落实2026年2月通过的《HOLD 法案》,修订活体器官捐献者费用报销计划的资格指引、减少活体捐献的经济障碍;HHS 并已对未达联邦安全、绩效与问责标准的器官获取组织采取撤销认证的行动。卫生资源与服务管理局(HRSA)局长 Tom Engels 表示,改革将帮助更多患者获得所需移植、改善整个移植系统的结局。
该计划列出三大优先方向:预防肾衰竭(早筛、早干预,推进可延缓或阻止病情进展的治疗与技术);改善透析护理并扩大患者选择(促进竞争、降低新提供者与新疗法的准入门槛、扩大居家护理);以及加强移植体系的安全。
HHS Launches Kidney Care National Plan to Transform Kidney Care in America
The U.S. Department of Health and Human Services (HHS) on October 20 launched the Kidney Care National Plan in Washington, a coordinated department-wide strategy focused on revitalizing American kidney care. As part of the Make America Healthy Again initiative, the plan will address the root causes of disease and implement better treatments at every stage of kidney disease, identifying where federal action can improve care across the entire spectrum, eliminate regulatory barriers to support innovation and a well-functioning kidney market, and deliver greater choice and superior outcomes.
"President Trump changed the course of kidney care in 2019 by challenging a system that waited for patients to reach kidney failure," said HHS Secretary Robert F. Kennedy, Jr. "Now HHS is building on that work by detecting kidney disease earlier, expanding treatment and home-care options, removing barriers to innovation and transplantation, and strengthening safety across the transplant system. Our goal is simple: preserve kidney health, give patients more choices, and help more Americans avoid kidney failure and live longer, healthier lives."
Kidney disease is one of the nation's most common chronic diseases, affecting an estimated 37 million American adults, according to HHS. Most of those affected do not know they have it, so treatment often begins only after significant damage has occurred, leaving patients dependent on lifelong dialysis or a kidney transplant. President Trump signed the landmark Executive Order Advancing American Kidney Health in 2019, establishing a federal vision to prevent kidney failure, expand patient choice, and increase access to transplantation, on which the 2026 plan builds.
The plan centers on three priorities: preventing kidney failure by detecting disease earlier and advancing treatments that can slow or stop progression; improving dialysis care and expanding patient choice by promoting competition, expanding home-based care, and supporting innovation; and reforming transplantation by strengthening safety, transparency, and accountability while expanding access to living and deceased-donor transplantation. As a pillar of the plan, HHS will advance a National Transplant Expansion Strategy to make living donation easier and more accessible.
"To Make America Healthy Again, we must confront chronic disease before it becomes catastrophic — and kidney disease is a clear example," said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. "Too many Americans are diagnosed after serious damage has occurred, while our system often waits for kidney failure instead of acting sooner."
HHS also cited work already underway: over the last 12 months the Food and Drug Administration (FDA) expanded the treatment landscape for serious kidney diseases, including the first FDA-approved treatment for certain patients with focal segmental glomerulosclerosis and the first treatment for adults with complement 3 glomerulopathy to reduce proteinuria, plus new therapies for immunoglobulin A nephropathy and idiopathic nephrotic syndrome; HHS is investing up to $4.67 million in the KidneyX Prize Competition with the American Society of Nephrology; an analysis released the same day by the Office of the Assistant Secretary for Planning and Evaluation associates the 2019 Executive Order with roughly 2,000 additional kidney transplants per year and projected economic benefits reaching $200 billion through 2040; HRSA has implemented the HOLD Act, passed in February 2026, streamlining living organ donor reimbursement; and HHS has moved to decertify organ procurement organizations that failed to meet federal standards. "Millions of people living with kidney failure deserve the best chance at a longer, healthier life," said HRSA Administrator Tom Engels.
The plan sets three priorities: preventing kidney failure through early screening and intervention and advancing treatments that can slow or stop progression; improving dialysis care and expanding patient choice by fostering competition, lowering entry barriers for new providers and therapies, and expanding home care; and strengthening the safety of the transplant system.
发布:GSM·美国(发布链接)
图片来源:图:患者接受血液透析治疗(资料图)。维基共享资源,CC0,作者 Anna Frodesiak/Photo: A patient receiving hemodialysis treatment (file photo). Wikimedia Commons, CC0, by Anna Frodesiak
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