China: 高值医用耗材"两票制"实操及应对探讨

Last Updated: 18 September 2019
Article by Liu Hui and Wang Xiaohui
Most Read Contributor in China, September 2019

2019年7月31日,国务院办公厅正式发布《治理高值医用耗材改革方案》(简称"《方案》"),标志着医改已全面深入到医疗器械领域。其中,高值医用耗材(或称"高值耗材") 1"两票制"作为一项流通领域的改革措施,被明确提上日程。《方案》鼓励各地通过"两票制"等方式减少高值耗材流通环节,强化流通管理,推动购销行为公开透明,完成时限为2020年底前。

《方案》的出台意味着高值耗材"两票制"将在全国范围内快速铺开,其改革范围和影响将进一步扩大。如何评估影响并作出应对,已成为高值耗材行业面临的共同问题,本文将就此展开讨论。

一、"两票制"政策背景及现状

"两票制"的政策和实践源起于药品领域。2016年4月,国务院办公厅发布《深化医药卫生体制改革2016年重点工作任务》,首次在国家层面提出药品"两票制",要求综合医改试点省份在全省范围内推行药品"两票制",即生产企业到流通企业开一次发票,流通企业到医疗机构开一次发票;鼓励医院与药品生产企业直接结算药品货款、药品生产企业与配送企业结算配送费用,压缩中间环节,降低虚高价格。2016年12月底,国务院在《"十三五"深化医药卫生体制改革规划》中明确提出实施药品采购"两票制"改革。2016年12月底,国务院医改办等八部门联合发布《公立医疗机构药品采购中推行"两票制"的实施意见(试行)》(简称"《药品"两票制"实施意见》"),对药品"两票制"的界定、实施范围、配套落地政策及监督检查作出具体的规定,正式在全国公立医院范围内推广落实药品采购"两票制"。在鼓励一票、推行两票、特殊/严控三票的政策推动下,药品"两票制"目前已基本在全国范围内落地。

在高值耗材领域,由于其有着明显区别于药品的产品特点和渠道模式,因此在"两票制"推进过程中,国家的政策更为谨慎。国家政策整体保持稳中求进的态度,至今尚未出台具体、统一的实施意见。从《2016年纠正医药购销和医疗服务中不正之风专项治理工作要点》提出在医改试点地区实行耗材采购"两票制",到2018年《关于巩固破除以药补医成果持续深化公立医院综合改革的通知》提出逐步推行高值医用耗材购销"两票制",再到2019年《治理高值医用耗材改革方案》明确鼓励通过"两票制"等方式进行流通领域改革,一系列连续政策表明,国家在耗材流通领域的改革方向是清晰、坚定且持续推进的。

地方层面,福建、安徽、陕西、青海、山西太原等地响应国家政策要求启动了耗材领域"两票制"的改革探索,自2017年起陆续出台了相应的政策文件,并在实施中形成了各自的渠道监管特点。个别地区,例如江苏泰州,明确鼓励实行"一票制",由有条件的生产企业直接向医院供货结算。同时,我们注意到上海、北京、深圳、浙江、江苏(除个别城市)、山东等地目前尚未出台具体的高值耗材"两票制"政策。

二、"两票制"代表性地区的政策要点及实践模式

"两票制"政策的核心在于压缩流通环节。面对医用耗材领域长期以来形成的多级、复杂的渠道模式,如何压缩、压缩到何种程度,目前尚无统一的实施指导意见,有赖于医改试点地区的实践经验总结。

回看药品"两票制",压缩流通环节的关键在于两大供应环节(即,生产企业到流通企业、流通企业到医院)的准确界定。《药品"两票制"实施意见》明确规定:药品生产企业或科工贸一体化的集团型企业设立的仅销售本企业(集团)药品的全资或控股商业公司(全国仅限1家商业公司)、境外药品国内总代理(全国仅限1家国内总代理)可视同生产企业。药品流通集团型企业内部向全资(控股)子公司或全资(控股)子公司之间调拨药品可不视为一票,但最多允许开一次发票。综上可见,《药品"两票制"实施意见》对于生产企业有明确的认定范围和条件,对于流通环节允许有条件调拨,否则将视作一票。药品"两票制"流通的渠道模式,参见下图一。

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文中注释:

1 :《关于印发高值医用耗材集中采购工作规范(试行)的通知》(卫规财发[2012]86号)第二条规定:"本规范所指高值医用耗材是指直接作用于人体,对安全性有严格要求、临床使用量大、价格相对较高、社会反映强烈的医用耗材。"根据该通知的附件《参考目录》,高值医用耗材包括血管介入类、非血管介入类、骨科植入、神经外科、电生理类、起搏器类、体外循环及血液净化、眼科材料、口腔科、其他等十大类。

2《反不正当竞争法》第七条第三款规定:"经营者的工作人员进行贿赂的,应当认定为经营者的行为;但是,经营者有证据证明该工作人员的行为与为经营者谋取交易机会或者竞争优势无关的除外。"

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