Tamsulosin Hydrochloride

5月23日，国家医保局向社会公开发布第一批医保基金智能监管规则库、知识库的规则和知识点。来源 | 国家医保局、新华网5月23日，国家医保局向社会公开发布第一批医保基金智能监管规则库、知识库的规则和知识点。此次公开发布的智能监管规则和知识点，在充分尊重医学规律、尊重临床实践的基础上，涵盖了药品区分性别使用、医疗服务项目区分性别使用、药品儿童专用、药品限儿童使用、医疗服务项目儿童专用等5类规则对应知识点明细。图源：国家医保局国家医保局要求，各省级医保部门要及时根据最新知识点明细及代码对省级医保信息平台智能监管子系统“两库”进行动态更新。守好百姓看病就医的“钱袋子”，离不开医保基金的智能监管。国家医保局有关负责人介绍，在飞行检查、打击欺诈骗保等医保基金监管工作中，大数据筛查和智能监管发挥了重要作用，而“两库”则是智能监管的核心。这位负责人说，希望通过公开智能监管“两库”的规则和知识点，进一步帮助定点医药机构通过智能化的技术手段主动、持续合规，实现监管关口前移，筑牢安全规范使用医保基金“第一道防线”。定点医药机构可以利用公开的智能监管规则和知识点开展自查自纠，对已完成医保结算的费用进行自主筛查，发现违规问题后及时进行整改。这位负责人表示，鼓励定点医药机构将智能监管“两库”置于本机构智能提醒等信息化系统中，或对接医保部门智能监管系统事前提醒功能模块，将不合规的行为消除在“萌芽”阶段。接下来，国家医保局将按照工作计划分批次推进“两库”规则和知识点的征求意见和公开发布工作。附：国家医保局基金监管司有关负责人就公开发布第一批医保基金智能监管规则和知识点工作答记者问一、公开发布智能监管规则和知识点有何重要意义？主要基于哪些考虑？近年来，我们积极推进大数据和智能监管手段在基金监管工作中的应用。在飞行检查、打击欺诈骗保等医保基金监管工作中，大数据筛查和智能监管发挥了重要作用，提供了有力的支撑。可以说，经过近年的探索和努力，智能监管已经成为医保基金监管的重要方式，通过大数据和智能监管手段，不断提升监管效率，提升监管的精准度。我们考虑，要将智能监管这一有效手段从事后的检查、数据筛查，向事前提醒、事中审核进行延伸，实现监管关口前移，从源头上减少违法违规使用医保基金问题的发生。近期，我们印发了《关于开展智能监管改革试点的通知》（医保办函〔2025〕40号），进一步推进监管改革试点，重点任务是坚持事前、事中、事后相结合，加快推进医保基金智能监管子系统的建设应用，尤其是要把事前提醒模块建设应用好，帮助定点医药机构和医务人员规范涉及医保基金使用的医药服务行为，规范医保基金使用行为。在开展智能监管事前提醒工作过程中，我们坚持实事求是，“两条腿走路”。一方面，依托医保信息平台建设事前提醒模块，允许所有定点医药机构免费接入、调用。另一方面，对于业务规模大、复杂程度高、信息技术实力强的大型医疗机构，我们通过智能监管的规则库、知识库（以下简称“两库”）的开放和共享，允许其直接将“两库”本地化部署、嵌入到HIS系统中，进一步提高事前提醒的效率和准确性。“两库”是智能监管的工作核心。我们希望通过公布公开智能监管“两库”的规则和知识点，进一步帮助定点医药机构通过智能化的技术手段主动合规、持续合规，从而实现监管关口前移，从源头上减少违法违规使用医保基金行为发生，筑牢安全规范使用医保基金“第一道防线”。二、“两库”公开和事前提醒是如何帮助定点医药机构主动合规的？不少定点医药机构和医务人员反映，医保政策较为复杂，难以全部准确掌握。因此，我们把一些医保政策中明确的规则和要求，把一些实践中定点医药机构容易出现的问题，内置到智能监管子系统的事前提醒模块，这样在医务人员开处方的时候，一旦系统发现违规行为就会发出提示，把问题解决在萌芽阶段，在向经办机构传送结算单据前也可以进行预审和自查。比如在就诊环节的事前提醒，重点是落实实名制就医购药、规范诊疗行为、规范计费收费、预警超量开药等。通过身份识别，严格执行实名就医购药制度，确保人证相符。对医务人员违反政策限定和不合理检查、诊疗、用药行为实时提醒，引导医务人员自觉遵守临床诊疗规范和医保管理政策，依法合规、合理规范开展医疗服务和计费收费。在向医保部门申请审核医保费用环节，可以调用规则对医保基金结算单据进行预审、自查，减少错误申报和不合规费用的申报。同时，定点医药机构还可以利用公开的智能监管规则和知识点开展自查自纠，对已完成医保结算的费用进行自主筛查，发现违规问题后及时进行整改。三、为确保智能监管规则和知识点科学精准、尊重医学规律、尊重临床实践采取了哪些措施？我们在制定发布智能监管规则和知识点的过程中，充分尊重医学规律、尊重临床实践。本次公开发布前，我们广泛征求了200余家医疗机构的意见。征求意见对象由各省级医保局推荐，每个省份不少于5家，以本地区影响力较大的知名医疗机构为主，适当兼顾社会办、中小医疗机构，共计200余家。征求意见对象具有广泛性、权威性、代表性。对于定点医药机构基于临床应用实际提出的意见建议，我们逐条组织论证、充分考虑，对合理化意见建议做到了能采尽采、应纳尽纳。比如，对于“药品区分性别使用”对应的知识点，部分定点医疗机构认为，部分药品虽然在说明书中标注性别限制，但临床上参考《超说明书用药专家共识》，存在跨性别使用的情况，涉及药品38种。如盐酸坦索罗辛缓释胶囊说明书“用于前列腺增生症引起的排尿障碍”，一般应限定男性使用。部分医院反馈意见认为，临床科室泌尿外科部分女性患者用此药品改善症状，促排石。我们采纳了相关药品跨性别使用具有合理性的建议，暂不将以上药品纳入“药品区分性别使用限定”的知识点，在监管工作中结合实际情况判定用药的合理性。经过广泛征求意见，公布的第一批智能监管“两库”包括药品区分性别使用、医疗服务项目区分性别使用、药品儿童专用、药品限儿童使用、医疗服务项目儿童专用等5类规则1万多条知识点明细。在这些规则及知识点的应用过程中，我们也会持续进行跟踪、评估和完善，不断提升“两库”的科学性和准确性。四、下一步如何推动“两库”规则和知识点的落地应用？对于公开发布的“两库”规则和知识点，我们要求各省级医保部门及时根据最新知识点明细及代码对省级医保信息平台智能监管子系统“两库”进行动态更新。鼓励定点医药机构将智能监管“两库”置于本机构智能提醒等信息化系统中，或对接医保部门智能监管系统事前提醒功能模块，将不合规的行为消除在“萌芽”阶段。下一步，我们将按照工作计划分批次推进“两库”规则和知识点的征求意见和公开发布工作，为定点医药机构自觉规范医药服务行为提供基础。同时，积极稳妥开展智能监管改革试点，指导参加试点的各统筹地区、医疗机构做好智能监管特别是事前提醒工作，注意收集提炼试典型经验和做法，及时进行总结推广。持续跟进“两库”规则和知识点在省级医保信息平台和定点医药机构落地应用情况，不断完善“两库”规则和知识点，不断优化智能监管子系统的功能，持续赋能医保部门、赋能定点医药机构，共同守护医保基金安全。责编｜米子 亦一封面图来源｜视觉中国出生10天后就查出了肾结石，甚至还可能一辈子伴有腹泻……他得的到底是什么病？丨医起推理吧那些“带癌上班”的医护，有人去世、有人逃离、有人坚守医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。☟戳这里，更有料！

Two Head-to-Head Randomized Trials Highlight Superior Early Patient Experience with the UroLift™ System for BPH1-2 First-Ever Analysis Utilizing the American Urological Association Quality Registry (AQUA) to Assess BPH Treatment Modalities Shows Strongest Symptom Improvement Score Shift with UroLift™ System at Three Months.3 First Study to Confirm Safety of Stabilized Hyaluronic Acid (sHA) Rectal Spacer in Cases with Rectal Wall Infiltration (RWI).4 WAYNE, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System’s advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes.1-2 The UroLift™ System, also referred to as Prostatic Urethral Lift (PUL), is the chosen leader in minimally invasive procedures for benign prostatic hyperplasia (BPH) in the U.S.5 “These studies underscore our commitment to evidence-based innovation. The UroLift™ System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life,” said Claus Roehrborn, MD,* professor of urology at UT Southwestern Medical Center and primary investigator on the studies. “With more than 14 years of BPH research behind us, including ongoing head-to-head comparisons, we’re giving clinicians and patients the critical data to support evidence-based shared decisions.”The following research presentations outlined the key findings from the studies: Results from the CLEAR RCT Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL vs. Rezum WVTT1† Men treated with the UroLift™ System were significantly more satisfied with their results at two weeks and at one month after treatment.1Those who received the UroLift™ System procedure also had shorter catheterization times, better symptom relief, and better sexual function outcomes during the early recovery period compared to Rezūm™ patients.1 UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT2† At three months, men who were treated with the UroLift™ System showed significantly better symptom improvement compared to those who took medication.2UroLift™ System patients reported better sexual function outcomes and overall experience.‡ In fact, 70% of men randomized to the medication treatment arm eventually chose to crossover to the UroLift™ System.2 Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment3 Real-world data from the AQUA BPH database corroborate evidence that BPH drugs provide modest or no improvement and that PUL provides rapid symptom score improvement at three months.3 Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility4 This study presents the first evidence for the safety of sHA rectal spacer in cases of RWI, demonstrating sHA spacers are safe, effective, and allow for individualized spacing with low risk of severe complications, such as ulcers or fistulas.4 “These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage,” said Michelle Svatos, director of Barrigel™ rectal spacer product development and research. “With a low incidence of rectal wall infiltration and no severe complications observed, this study strengthens our confidence in sHA as a safe and customizable option for protecting patients during prostate cancer treatment." For more information about the UroLift System, visit www.UroLift.com, and for more information about Barrigel Rectal Spacer, visit www.Barrigel.com. About the UroLift™ SystemThe UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure,6 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.7 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**8-9 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability.10 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.11 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide.12 Learn more at www.UroLift.com. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Barrigel™ Rectal SpacerBarrigel™ rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer.13 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).14 Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.15-16 Barrigel™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy13 and is cleared for rectal spacing in the United States, Australia, and Europe.17 Barrigel™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters. Barrigel™ Rectal Spacer Important Safety InformationBarrigel™ rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time. Barrigel™ rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. As with any medical treatment, there are some risks involved with the use of Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com. Individual results may vary. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners. © 2025 Teleflex Incorporated. All rights reserved. References *Paid consultants of Teleflex.**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study †Studies sponsored by Teleflex.‡Sexual function is a combination of MSHQ EjD, MSHQ Bother, and IIEF scores. For overall patient experience, this includes a combination of results from tools to assess Symptoms, QoL, Patient Perception, Goal Achievement, and Sleep. Chughtai et al, AUA 2025. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT. †Roehrborn et al, AUA 2025. UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT.†Roehrborn. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment. Poster presented at AUA; April 26, 2025. Las Vegas, NV.Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility.U.S. 2023 estimates based on US Market Model 2023-25 (3-14-23 FINAL), which is in part based on Symphony Health PatientSource® 2018-22, as is and with no representations/warranties, including accuracy or completeness.Shore, Can J Urol 2014Rukstalis, Prostate Cancer and Prostatic Dis 2018AUA BPH Guidelines 2003, 2020McVary, Urology 2019Roehrborn, Can J Urol 2017Roehrborn, J Urol 2013Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology.Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).Barrigel Injectable Gel Instructions for Use (2022).Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. https://doi.org/10.1002/mp.17292†Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.Data on file Teleflex. 2025. MAC03086-01 Rev A Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com646-871-8485