国家医保局:各地年底前建立医药价格和招采信用评价制度

2020-09-16 国家医保局 国家医保局

近期,国家医保局印发了《关于建立医药价格和招采信用评价制度的指导意见》(以下简称《意见》),要求各地于2020年底前建立并实施医药价格和招采信用评价制度。

近期,国家医保局印发了《关于建立医药价格和招采信用评价制度的指导意见》(以下简称《意见》),要求各地于2020年底前建立并实施医药价格和招采信用评价制度。

《意见》聚焦医药领域给予回扣等行为造成的药品和医用耗材价格虚高、医疗费用过快增长、医保基金大量流失,加重群众医药费用负担,侵害群众切身利益等突出问题,发挥医药产品集中采购市场的引导和规范作用,促进医药企业按照公平、合理和诚实信用、质价相符的原则制定价格,促进医药产品价格合理回归。

《意见》明确,医药价格和招采信用评价制度不同于传统上基于行政管理关系的信用监管,是基于药品和医用耗材集中采购的买卖合同关系,在医药企业出现给予回扣等违反公平合理、诚实信用定价行为时,由药品和医用耗材集中采购机构按照信用承诺采取措施,维护采购方和消费方的合法权益。

《意见》提出,一是目录清单。将给予回扣等有悖诚实信用的行为纳入评价范围。二是企业承诺。要求参加药品和医用耗材集中采购的医药企业作出守信承诺。三是信息记录。采取企业报告与平台记录相结合的方式掌握医药企业失信信息。四是信用评级。依据法院判决或行政处罚认定的案件事实,确定失信等级,动态更新。五是分级处置。分级采取提醒告诫、提示风险、限制或中止投标挂网、公开披露失信信息等处置措施。六是信用修复。鼓励企业整改,采取切实措施主动修复信用。

信用评价制度具体由各省级药品和医用耗材集中采购机构组织实施。

国家医疗保障局关于建立医药价格和招采

信用评价制度的指导意见

医保发〔2020〕34号

各省、自治区、直辖市及新疆生产建设兵团医疗保障局、药品和医用耗材集中采购机构:

医药领域给予回扣、垄断控销等行为造成药品和医用耗材价格虚高、医疗费用过快增长、医保基金大量流失,加重人民就医负担,侵害群众切身利益。为贯彻落实《中共中央国务院关于深化医疗保障制度改革的意见》,推进完善以市场为主导的医药价格形成机制,促进医药企业按照公平、合理和诚实信用、质价相符的原则制定价格,依据《价格法》《药品管理法》等法律法规,现就建立医药价格和招采信用评价制度,提出以下指导意见。

一、指导思想

以习近平新时代中国特色社会主义思想为指导,全面贯彻党的十九大和十九届二中、三中、四中全会精神,坚持医药价格治理创新,基于药品和医用耗材集中采购中的买卖合同关系,依托药品和医用耗材招标采购平台,系统集成守信承诺、信用评级、分级处置、信用修复等机制,建立权责对等、协调联动的医药价格和招采信用评价制度,促进各方诚实守信,共同营造公平规范、风清气正的流通秩序和交易环境,切实保障群众利益和医保基金安全,使人民群众有更多获得感、幸福感、安全感。

二、建立信用评价目录清单

国家医疗保障局建立医药价格和招采失信事项目录清单,实行动态调整,列入目录清单的失信事项主要包括在医药购销中给予回扣或其他不正当利益(以下简称“医药商业贿赂”)、涉税违法、实施垄断行为、不正当价格行为、扰乱集中采购秩序、恶意违反合同约定等有悖诚实信用的行为。自本意见印发之日起,医药企业(含药品生产许可持有人、药品和医用耗材生产企业、与生产企业具有委托代理关系的经销企业,以及配送企业,下同)在定价、投标、履约、营销等过程中,通过目录清单所列失信事项牟取不正当利益的,纳入医药价格和招采信用评价范围。

三、实行医药企业主动承诺制

医药企业参加或委托参加药品和医用耗材集中采购、平台挂网,以及公立医疗机构和医保定点的非公立医疗机构(以下统称“医疗机构”)开展的备案采购,应以独立法人名义向相关药品和医用耗材集中采购机构(以下简称“集中采购机构”)提交书面承诺,承诺事项包括建立合规审查制度,杜绝失信行为,规范其员工(含雇佣关系)或具有委托代理关系的经销企业销售己方药品或医用耗材的行为,承担相应的失信责任,接受处置措施等。

四、建立失信信息报告记录渠道

通过企业报告和平台记录相结合的方式,及时全面、完整规范地采集医药企业失信行为信息,建立失信信息库。医药企业应主动及时向失信行为发生地的省级集中采购机构报告失信信息。在国家医疗保障局和相关部门的合作框架下,省级集中采购机构定期梳理汇总相关部门公开或共享的裁判文书、行政处罚决定文书等,采集校验医药企业失信信息并予以记录。省级集中采购机构日常运行中通过监测、受理举报等方式,掌握医药企业定价、投标、履约、营销等方面的失信行为信息并予以记录。

五、开展医药企业信用评级

省级集中采购机构按照来源可靠、条件明确、程序规范、操作严密的要求实施信用评级,根据失信行为的性质、情节、时效、影响等因素,将医药企业在本地招标采购市场的失信情况评定为一般、中等、严重、特别严重四个等级,每季度动态更新。对于涉及违法违规的失信行为、信用评级所依据的事实,以法院判决或行政处罚决定认定事实为准。国家医疗保障局授权并指导监督医药价格和招标采购指导中心制定信用评价的操作规范和信用评级的裁量基准,规范各地信用评价评级工作。各省(区、市)可在国家制定发布的操作规范和裁量基准基础上,探索量化评分的信用评级方法,提升信用评级的标准化规范化水平。

六、分级处置失信违约行为

省级集中采购机构根据医药企业信用评级,分别采取书面提醒告诫、依托集中采购平台向采购方提示风险信息、限制或中止相关药品或医用耗材挂网、限制或中止采购相关药品或医用耗材、披露失信信息等处置措施,失信行为涉及省份数量达到规定条件的,由国家医疗保障局医药价格和招标采购指导中心启动全国联合处置。涉事药品或医用耗材供给结构单一、供需形势紧张的,在保障供应的基础上采取分级处置措施。

七、鼓励医药企业修复信用

建立医药企业信用修复机制。失信行为自被确认起超过一定时间,以及相关司法判决、行政处罚决定被依法撤销或改变的,保留记录但不再计入信用评级范围。省级集中采购机构在处置措施生效前提醒告知医药企业,并视情形给予一定的申诉和整改期,允许企业补充更正信息、申诉说明情况。鼓励企业采取切实措施主动修复信用,包括终止相关失信行为、处置失信责任人、提交合规整改报告并接受合规检查、公开发布致歉声明消除不良影响、剔除涉案药品或医用耗材价格中的虚高空间、退回或公益性捐赠不合理收益、有效指证失信行为的实际控制主体等。

八、正确运用医药价格和招采信用评价

各省级集中采购机构实施医药价格和招采信用评价,应接受省级医疗保障部门的指导和监督,坚持以客观事实为依据,以法律法规为准绳,以市场机制为导向,以买卖合同关系为基础,保障医药企业依法享有自主定价、自主经营权利,不得以医药价格和招采信用评价制度名义,实施地方保护、破坏公平竞争。

九、共同推进信用评价制度建设

各省级医疗保障部门应在2020年底前,指导监督本省份集中采购机构建立并实施医药价格和招采信用评价制度。坚持共建共治共享原则,推动医药企业、医疗机构积极参与,引导医药企业自觉履行遵守价格规则、诚信经营的义务,引导医疗机构同等条件下优先选择信用评级更优的医药企业作为供应或配送单位。集中采购机构要深入推进标准化规范化建设,改善招标采购服务,充分利用信息化手段,为医药企业提交承诺、记录信息、修复信用等提供便捷高效的服务和支撑。

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    2020-09-18 wgx306
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    2020-09-18 cathymary
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    2020-09-18 huagfeg
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