China: 医疗机构投资并购之法律尽职调查实务分析

Last Updated: 8 August 2019
Article by Deng Weifang, Lei Yali and Jiang Fuchao
Most Read Contributor in China, November 2019

在国家医疗体制改革、支持社会办医及医疗大健康产业飞速发展的背景下,医疗机构并购领域已成为传统医疗集团和各路产业资本(地产商、投资机构、药械企业、险资等)竞相角逐的热点。其中,因医疗机构具备长期持续经营、稳定收益和较低风险的特点,契合保险资金运用,近年来商业保险机构参与健康服务业产业链整合,通过股权投资、战略合作等多种方式投资医疗机构打造"保险+医疗"模式已跻身保险资金投资领域的热点。

值得一提的是,2019年6月10日,国家卫生健康委员会联合中国银行保险监督管理委员会、国家发展和改革委员会等十部门共同发布《关于促进社会办医持续健康规范发展的意见》("《促进社会办医意见》"),从加大政府支持力度、简化审批服务、完善医疗保险政策等6个方面,提出促进社会办医持续健康规范发展的22项政策措施,为解决实践中社会资本投资、管理、运营医疗机构存在的问题及障碍进一步指明了改革方向。

按照过往行业经验,《促进社会办医意见》的颁布及未来配套政策措施的落地,将对社会资本并购医疗机构起到积极的推动作用。基于此,笔者将结合医疗机构并购项目法律尽调经验,立足于医疗机构并购尽职调查中重点关注的法律问题进行简要介绍和分析。

一、医疗机构的性质问题

对医疗机构进行尽职调查时,通常首先关注的问题是该医疗机构的性质或类别。一方面,不同性质的医疗机构适用的政策不同;另一方面,医疗机构的性质通常会对后续并购交易架构的安排具有重大影响。

关于医疗机构的分类,实践中存在多种分类标准,如按照"医疗机构的经营目的、服务任务,以及执行不同的财政、税收、价格政策和财务会计制度" 1,可以分为非营利性医疗机构和营利性医疗机构;按照医疗行业标准 2,又可以分为综合医院、专科医院、康复医院等;按照举办人的性质,可以分为公立医疗机构和社会资本举办医疗机构。

1.非营利性医疗机构与营利性医疗机构

除医疗机构执业许可证所载明的"非营利性"或"营利性"性质区分外,非营利性医疗机构与营利性医疗机构的其他不同点主要体现在以下方面:

2.按照行业标准分类

根据《医疗机构管理条例实施细则》第三条的规定,按照医疗机构的诊疗科目、规模等,医疗机构可分为十四类 6。按照医院分级管理标准,医院可分为三级医院、二级医院及一级医院,每级医院再划分为甲、乙、丙三等,同时三级医院中在甲、乙、丙三等之上增设特等,因此医院共可分三级十等。

医院分级制度下,各级医院的定价、社保报销比例、医疗资源等存在差异,患者可将医院评定等级作为相对有效的参考指标,这也是收购方在尽调中需了解的基本情况之一。此外,按照《医疗机构基本标准(试行)》、《综合医院配置标准》、《康复医院基本标准(2012年版)》及《三级综合医院评审标准实施细则》等标准或规则,等级医院评审对床位数、医护人员配置比例、科室设置、房屋建筑面积、医疗设备等要素均提出了相应标准,如未满足相关标准,可能影响医疗机构执业许可证及其他医疗资质的定期校验审批。在法律尽调中,核查标的医院的级别及是否符合对应的医院标准是基础的尽调事项之一。

二、医疗机构的业务资质问题

医疗机构是否具备适格的业务资质关乎其能否合法合规运营,对医疗机构业务资质的核查是法律尽调中的重点关注事项,以下按医疗机构执业资质、医疗设备/特殊诊疗技术/服务资质以及医疗人员资质分类进行简要梳理与归纳。

1.医疗机构执业资质

从医疗机构的设立到执业运营,所涉及到资质许可主要包括医疗机构设置批准书、医疗机构执业许可证及定期校验许可,具体如下:

2.医疗设备/技术/服务资质

根据相关法规并结合尽调实践,国家对大型医用设备实行分级分类配置规划和配置许可证管理,对特殊诊疗项目实行审批或备案制,对特殊医疗技术临床应用实行负面清单管理制,相关资质要求及医疗机构未取得资质从业的法律后果如下所示:

3.医疗人员资质

按是否需取得行政许可分类,医疗技术人员可分为行政许可类和水平评价类(即非行政许可类,如:药物制剂人员、中药饮片加工人员、健康管理师、保健调理师等),其中行政许可类资质相关注册要求及未取得资质从业的法律后果如下:

三、医疗机构所涉环保核查问题

1.环境影响评价

根据《建设项目环境影响评价分类管理名录》("《管理名录》")相关规定,对建设项目的环境保护实行分类管理;对于医院、专科防治院(所、站)、社区医疗、卫生院(所、站)、血站、急救中心、妇幼保健院、疗养院等卫生机构,新建、扩建床位500张及以上的应当编制环境影响报告书;20张床位以下的应当填报环境影响登记表;其他类型的医疗机构,应当编制环境影响报告表。

对于医疗机构未依法报批建设项目环境影响报告书/表擅自开工建设("未批先建")的违法行为,根据《关于建设项目"未批先建"违法行为法律适用问题的意见》(环政法函201831号)的规定,建设项目于2016年9月1日后开工建设,或者2016年9月1日之前已经开工建设且之后仍然进行建设的,立案查处的环保部门应当适用新环境影响评价法第三十一条的规定进行处罚,不再依据修正前的环境影响评价法作出"限期补办手续"的行政命令;"未批先建"违法行为自建设行为终了之日起二年内未被发现的,环保部门应不予行政处罚。对于医疗机构未批先建的同时未建成配套的环境保护设施、未经验收或者验收不合格却投入使用的,由于违反环保设施"三同时"验收制度的违法行为处于持续状态,因此不受行政处罚两年追溯时限的影响,需按照《建设项目环境保护管理条例》第二十八条的规定作出相应处罚。

此外,根据笔者向北京市、江苏省、浙江省等地卫生行政部门的匿名电话咨询结果,申请医疗机构执业许可证时需要提交医疗机构竣工验收的相关批准文件或证明材料,包括环评批复文件。因此,在部分地区实操中,若医疗机构未按要求办理环评手续的,可能无法取得医疗机构执业许可证。

2.排污许可与排水许可

根据《排污许可管理办法(试行)》第三条规定,环境保护部依法制定并公布固定污染源排污许可分类管理名录,明确纳入排污许可管理的范围和申领时限,纳入固定污染源排污许可分类管理名录的企业事业单位和其他生产经营者应当按照规定的时限申请并取得排污许可证;未纳入固定污染源排污许可分类管理名录的排污单位,暂不需申请排污许可证。《固定污染源排污许可分类管理名录(2017年版)》明确,综合医院、中医医院、中西医结合医院、民族医院、专科医院(以上均不包括社区医疗、街道和乡镇卫生院、门诊部以及仅开展保健活动的妇幼保健院)、疾病预防控制中心中,床位100张及以上的属于实施重点管理的行业,床位20张至100张的(疾病预防控制中心除外)属于简化管理的行业,依法均应申请排污许可证。

《城镇污水排入排水管网许可管理办法》相关规定,从事医疗活动的排水户向城镇排水设施排放污水应申领排水许可证。

视各地实践操作,部分地区环保主管部门认可由整栋物业的业主统一办理排污许可证及排水许可证,也有要求医疗机构单独申请领取排污许可证及排水许可证之情况。在法律尽调中,建议与环保主管部门咨询当地实践操作。

四、医疗机构物业用途管制问题

受制于医疗用地供给政策,社会办医建设医疗用房的途径主要包括自行购地与租赁物业改建两种方式,其中租赁物业改建是较为常见模式。近年来部分上市公司(如:爱尔眼科、华润医疗、新世纪医院、和美医疗、康华医疗等)及其子公司的经营场所主要通过租赁取得,该种轻资产运营模式虽具有降低一定期限内成本的优势,但往往面临房屋规划用途及土地用途不符合规划、房屋产权瑕疵等问题。在笔者参与的医院收购类项目中,存在租赁厂房、科研办公用房、老年活动中心(对应土地用途为文体娱乐用地)、体育场、商业和办公甚至住宅改建医疗用房的情形。就此,前述情形是否违反土地用途与房屋规划用途管制、存在何种后果以及是否影响医疗机构经营稳定是收购方关切的问题。

根据我国现行的土地用途管制制度,必须严格按照土地利用总体规划确定的用途使用土地,依法改变土地权属和用途的,应当办理土地变更登记手续,而按照《土地利用现状分类》(GB/T21010-2017)和《城市用地分类与规划建设用地标准》(GB50137-2011)的规定,医疗机构对应的用地性质应为医疗卫生用地。同时,土地使用权人与国土局签订的土地出让合同中常规设置了改变土地用途和土地使用条件的应办理变更批准手续并重新签订出让合同相关条款,违反之存在被收回土地使用权的风险。此外,从房屋规划角度,各地(如:北京市、浙江省等)城乡规划条例一般均明确不得擅自改变房屋规划用途,违反之存在责令改正、罚款甚至收回土地使用权的处罚后果。至此,我们理解应然层面上,将非医疗服务用途的房屋用作医疗服务用途涉嫌未经批准变更土地用途和房屋规划用途,存在被国土与城市规划部门要求整改的风险(包括但不限于责令限期改正、罚款、收回土地使用权等)。

但在实践层面,目前社会办医持续支持性政策显示对医疗用房的规划用途限制有望逐步放开——《促进社会办医意见》提出允许使用其他用途的存量房屋用于办医,其具体表述为"城市、县人民政府自然资源主管部门依据法律法规和经批准的城乡规划,制定暂不改作医疗服务相关规划用途的现有房屋设施用于举办医疗机构的要求细则,并明确办事流程。"此外,在笔者经办的医院并购项目中,实操中主管部门在审核设立医疗机构时对医院选址及租赁房屋原土地用途与房屋规划用途的审核偏宽松,在投资人提前与卫生、环保等主管部门沟通的情况下,利用非医疗服务用途的房屋开设医疗机构设立审批可采取"一事一议"方式。例如,北京市某区出于对辖区内医疗卫生需求保障、院方综合实力等因素考虑,原则同意利用厂房、科研用房改建医院;基于对医院项目性质、合作方综合实力等因素考量,北京市某区原则同意投资人利用商业房屋开设专科医院等。

值得关注的是,《促进社会办医意见》明确"经土地和房屋所有法定权利人及其他产权人同意后,对闲置商业、办公、工业等用房作必要改造用于举办医疗机构的,可适用过渡期政策,在5年内继续按原用途和权利类型使用土地,但原土地有偿使用合同约定或划拨决定书规定不得改变土地用途或改变用途由政府收回土地使用权的除外。"该项过渡期政策虽然在适用前提上进行了限定,但仍为当下社会办医房屋土地使用政策打开了突破口,各地如何响应并落实存量房屋在不改变规划用途的情况下用于医疗服务用途有待地方性操作细则出台。同样地,如果医疗政策趋严,主管部门可能严格审核并限制利用非医疗服务用途房屋办医,届时已取得医疗机构执业许可的存量医院项目能否确保长期经营稳定存在不确定性。

Footnotes

1 详见卫生部、国家中医药管理局、财政部、国家计委《关于印发<关于城镇医疗机构分类管理的实施意见>的通知》(卫医发2000233号)。

2详见《医疗机构管理条例实施细则》(2017年2月21日修订)。

3 2000年12月05日《民政部、卫生部关于城镇非营利性医疗机构进行民办非企业单位登记有关问题的通知》(民发2000253号)规定,"各类城镇非营利性医疗机构(政府举办的非营利性医疗机构除外)在取得《医疗机构执业许可证》后,应当依法到民政部门进行民办非企业单位登记:......社会捐资兴办的非营利性医疗机构、社会团体和其他社会组织举办的非营利性医疗机构、企事业单位设立的对社会开放的且其总财产中的非国有资产份额占三分之二以上的非营利性医疗机构、国有或集体资产与医疗机构职工集资合办的且其总财产中的非国有资产份额占三分之二以上的非营利性医疗机构、自然人举办的合伙或个体非营利性医疗机构"。

4《物权法》第一百八十四条:"下列财产不得抵押:......(三)学校、幼儿园、医院等以公益为目的的事业单位、社会团体的教育设施、医疗卫生设施和其他社会公益设施;......"

5《关于促进社会办医加快发展的若干政策措施》(国办发【2015】45号)第二(七)条,鼓励金融机构根据医疗机构特点创新金融产品和服务方式,扩大业务规模。拓宽信贷抵押担保物范围,探索允许社会办医疗机构利用有偿取得的用于非医疗用途的土地使用权和产权明晰的房产等固定资产办理抵押贷款。

6根据2017年4月1日修订后的《医疗机构管理条例实施细则》第三条的规定,医疗机构的类别可以分为:

(一) 综合医院、中医医院、中西医结合医院、民族医医院、专科医院、康复医院;

(二) 妇幼保健院、妇幼保健计划生育服务中心;

(三) 社区卫生服务中心、社区卫生服务站;

(四) 中心卫生院、乡(镇)卫生院、街道卫生院;

(五) 疗养院;

(六) 综合门诊部、专科门诊部、中医门诊部、中西医结合门诊部、民族医门诊部;

(七) 诊所、中医诊所、民族医诊所、卫生所、医务室、卫生保健所、卫生站;

(八) 村卫生室(所);

(九) 急救中心、急救站;

(十) 临床检验中心;

(十一) 专科疾病防治院、专科疾病防治所、专科疾病防治站;

(十二) 护理院、护理站;

(十三)医学检验实验室、病理诊断中心、医学影像诊断中心、血液透析中心、安宁疗护中心

(十四) 其他诊疗机构。

7《大型医用设备配置与使用管理办法(试行)》第九条

8 《医疗器械监督管理条例(2017年修订)》第六十三条

9 《放射诊疗管理规定》第四条

10 《放射诊疗管理规定》第三十八条

11 《放射性同位素与射线装置安全许可管理办法》第二条

12 《放射性同位素与射线装置安全许可管理办法》第三十六条

13 《放射性同位素与射线装置安全和防护条例》第五十二条

14 《母婴保健专项技术服务许可及人员资格管理办法(2019年修订)》第二条

15 《中华人民共和国母婴保健法(2017年修订)》第三十五条

16 《中华人民共和国药品管理法实施条例》第二十条

17 《中华人民共和国药品管理法》第七十三条

18 《麻醉药品和精神药品管理条例》第三十六条

19 《麻醉药品和精神药品管理条例》第七十二条

20 《医疗广告管理办法》第三条

21 《医疗广告管理办法》第二十条

22 《执业医师法(2009年修订)》第十四条

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