New regulations of online drug trading
On November 12th, the NMPA issued the “Measures for the Supervision and Regulation of Online Drug Trading (Consultation Paper).” The paper clarifies that drug trading enterprises can only sell drugs that are allowed to be sold; special drugs such as vaccines, anesthetics and psychotropic drugs are not allowed to be traded online. The paper also indicates that drug trading enterprises that are allowed to sell prescription drugs online should check the source of electronic prescription and the dispensing in the prescription and mark the used prescription. Moreover, drug trading enterprises should provide online medical services and employ pharmacists to guide the public to use drug rationally.
药品网售新规来了：不得销售麻醉、精神药品等
来源：医药网 2020.11.13
11月12日，国家药监局公布《药品网络销售监督管理办法（征求意见稿）》。《意见稿》明确，药品网络销售不得超出企业经营方式和药品经营范围；疫苗、麻醉药品、精神药品等特殊药品不得通过网络销售。《意见稿》指出，具备网络销售处方药条件的药品零售企业应检查电子处方来源，审核处方调剂，并对已使用的处方进行电子标记；在销售同时，应当建立在线药学服务制度，配备执业药师，指导合理用药。
Unified reimbursement rate of online and offline medical consultations
Recently, the NMPA issued the “Guidelines on Promoting the Medical Insurance Payment of Online Medial consultation services.” The “Guidelines” clarifies that medical entities can help eligible online medical institutions that rely on them to be included in medical insurance, and the reimbursement rate for online and offline medical institutions is the same. The “Guideline” indicates that the payment of consultations and drugs for patients that need further consultations is also included in the medical insurance, which should be paid according to the regulations in different cities.
国家医保局：“互联网+”医保支付采取线上线下一致
来源：医药网 2020.11.04
日前，国家医疗保障局印发《关于积极推进“互联网+”医疗服务医保支付工作的指导意见》。《意见》明确，符合条件的互联网医疗机构可以通过其依托的实体医疗机构，自愿“签约”纳入医保定点范围，“互联网+”医保支付将采取线上、线下一致的报销政策。《意见》提出，医保参保人在本统筹地区“互联网+”定点医疗机构复诊并开具处方发生的诊察费和药品费，可以按照当地医保规定支付。
The NMPA: implementation of Diagnosis-Intervention Packet
On October 19th, the NMPA issued the “Notice on the Pilot Work of the Regional Point-Based Medical Insurance Fund Allocation and the Diagnosis-Intervention Packet.” The “Notice” stipulates that medical institutions should change the costs of each medical services into points; the regional medical insurance bureaus should calculate the value of each point according to the amount of points provided by all medical institutions of each region and the budget of medical insurance funds to pay for those medical institutions (Diagnosis-Intervention Paket). The “Notice” indicates that a data center on the basis of the unified national medical insurance information coding list should be established, which can inspect the quality of medical insurance settlement checklists, medical insurance cost schedule etc.
国家医保局发布区域点数法总额预算和按病种分值付费试点工作方案
来源：HIT专家网 2020.10.20
10月19日，国家医保局下发《国家医疗保障局办公室关于印发区域点数法总额预算和按病种分值付费试点工作方案的通知》（以下简称《通知》）。《通知》要求，医疗机构应将治疗项目等付费单元转化为一定点数；医保部门年底根据各医疗机构所提供服务的总点数以及地区医保基金支出预算得出每个点的实际价值，按照各医疗机构实际点数付费。《通知》指出，应打造数据中心，在全国统一的相关医保信息业务编码的基础上，开展医保结算清单、医保费用明细表等质量控制工作。
Solicting opinions on drug recall
On October 13th, the NMPA issued the “Measures on Drug Recall (Consultation Paper)” to solicit opinions from public. The Consultation Paper stipulates that Markeiting Authorization Holders should establisch and improve the drug recall system, collect information on drug safety issues, and investigate and evaluate defective or potentially harmful drugs in order to recall them on time.
公开征求《药品召回管理办法（征求意见稿）》
来源：医药网 2020.10.14
10月13日，国家药监局综合司公开征求《药品召回管理办法（征求意见稿）》。《征求意见稿》要求，药品上市许可持有人应当建立并完善药品召回制度，收集药品安全的相关信息，对可能存在缺陷的药品进行调查、评估，及时召回缺陷药品。
NMPA: establishing a traceabiliy system of specially regulated drugs
On August 28th, the NMPA issued the “Notice of establishing the traceability system of special drugs.” The Notice indicates that the Marketing Authorization Holders should establish traceability systems and collect the information from the traceability process to realise the traceability of special regulated drugs, such as selected drugs, before December 31st. At the meantime, the NMPA should establish a Coordination Platform of traceability systems, which provides coding rules of drug traceability codes and services that encode the IP-Adresse of traceability systems that are established by Marketing Authorization Holders to help to realise the information sharing between the different traceability systems.
国家药监局：做好重点品种信息化追溯体系建设工作
来源：医药网 2020.10.14
8月28日，国家药监局发布《关于做好重点品种信息化追溯体系建设工作的公告》。《公告》指出，药品上市许可持有人应建立信息化追溯系统并收集全过程追溯信息，于2020年12月31日之前，基本实现国家药品集中采购中选品种等重点品种可追溯。同时，国家药监局应建设药品追溯协同服务平台，协同平台提供药品追溯码编码规则备案和药品上市许可持有人药品信息化追溯系统地址解析服务，辅助实现不同追溯系统互通互享。
Hainan: supervising the drug procurement process
On October 10th, the Hainan Medical Insurance Bureau issued the “Plan on Supervising and Evaluating the Medical Price in Hainan Province.” The “Plan” clarifies that drugs included in the procurement list on the website of the centralised procurement platform of Hainan Province should be supervised, which means that monitoring and early warning systems will be implemented as drugs are published on or removed from the website as well as during the processes of drug procurement, distribution, use, and purchase. In addition, a centralised drug procurement assessment for medical institutions should be developed, in which will be evaluated particularly whether medical institutions have obeyed the purchase agreement and paid for the drugs with in 30 days, the rate of drug cost compared with the whole medical costs in medical institutions, the rate and purchasement of unselected drugs, and illegal purchase behavior.
医保局推药品采购全流程监测预警！严抓30天回款率
来源：医药网 2020.10.12
10月10日，海南省医疗保障局印发《海南省医药价格综合监管评价服务工作方案》（以下称《工作方案》）。《工作方案》明确，将在海南省医药集中采购平台挂网采购的药品纳入监测内容，对药品的挂网、撤网、采购、配送、使用和回款等全流程实施监测预警。 另外，应设置医疗机构的药品集中采购考核，其中对于协议完成率、30天汇款率、药占比、非中选产品采购量及金额占比、违规采购行为等进行了重点评分规定。
Coding rules for chinese traditional drugs
On September 25th, the NMPA issued the “Coding Rules of Chinese Traditional Drugs Included in the Reimbursement List and Pharmaceutical Preparations of Medical Institutions.” The code of Chinese traditional drugs consists of 10 digits and four sections. The first section represents Chinese traditional drugs. The second section represents different medical standards in different cities. The third section represents drug effects. The fourth section represents the name of drug. The code of pharmaceutical preparation of medical institutions consists of 16 digits and 4 sections. The first section represents pharmaceutical preparations. The second section represents different medical institutions in different cities. The third section represents medical institutions. The fourth section represents the sequence of pharmaceutical preparations in different medical institutions.
医保药品中药饮片和医疗机构制剂统一编码规则和方法
来源：医药网 2020.09.27
9月25日，国家医保局印发了《医保药品中药饮片和医疗机构制剂统一编码规则和方法》。中药饮片分为4个部分共10位。其中，第1部分是中药饮片识别码，第2部分是标准分类码，第3部分是功效分类码，第4部分是中药饮片名称码。医疗机构制剂编码分4个部分16位。其中，第1部分是医疗机构制剂识别码，第2部分是行政区划代码，第3部分是定点医疗机构顺序码，第4部分是医疗机构制剂顺序码。
The State Council: encouraging online drugs trade, prescription sharing and online medical consulting services
On September 21st, the State Council issued the “Opinions on Accelerating the Development of Consumption Created by New Forms of Bussiness”. The “Opinion” stipulates that a public service platform of online and e-commerce services should be established and improved to accelerate the integration of online and offline services; online medical services should be developed, which means scheduled appointments of consulting services, online medical consulting services, prescription sharing and online drugs trade will be promoted.
国务院力挺网络售药、处方流转、互联网医疗
来源：医药网 2020.09.23
9月21日，国务院办公厅印发《关于以新业态新模式引领新型消费加快发展的意见》（以下简称《意见》）。《意见》要求，应建立健全“互联网+服务”、电子商务公共服务平台，加快社会服务在线对接、线上线下深度融合；积极发展互联网健康医疗服务，大力推进分时段预约诊疗、互联网诊疗、电子处方流转、药品网络销售等服务。
Developing evaluating systems of drug pricing and bidding and procurement performence
On September 16th, the NHSA offically issued the “Guidelines on Establishing a Evaluating System of Drug Pricing and Bidding and Procurement Performence,” which stipulates that each province should establish and launch their own system before the end of 2020. The “Guidelines” clarifies that centralised procurement organizations of drugs and medical equipments should prevent pharmaceutical companies from fixing unreasonable drug price, such as via giving kickback to hospitals. At the meantime, the pharmaceutical companies that do not act properly will be documented and punished according to different levels of dishonesty while they are also encouraged to rectify to regain their credit score.
医保局：医药价格和招采信用评价年底前落地！
来源：医药网 2020.09.17
9月16日，国家医保局官网正式发布了《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》明确，药品和医用耗材集中采购机构应采取措施制止医药企业给予回扣等不合理定价行为。同时，应记录失信医药企业信息，根据不同失信等级采取不同处置措施，并鼓励企业整改，主动修复信用。
Pharmacy chains can only rise the price of drug in the reimbursement list by 15%
On September 1st, the “Reform Project on Improving the Functions of the Centralised Drug Procurement Platform and Promoting a Full Coverage of Payment Requirement of Drugs on the Reimbursement List in Zhejiang Province” was implemented. The “Project” indicates that drugs included in the list of online transactions on the provincal procurement platform of drugs and medical equipments are included in the provincal drug reimbursement list. Designated public medical institutions and private medical institutions should fix the drug price that accords with the price on the drug reimbursement list while pharmacy chains can rise the price upto 15% based on the price on the list.
9月1日起执行：医保用药 药店只能加价15%
来源：医药网 2020.09.03
9月1日，《浙江省提升药品集中采购平台功能推进医保药品支付标准全覆盖改革方案》正式实施。《方案》明确，所有纳入该省药械采购平台在线交易的医保目录内药品均纳入医保支付范围。其中，定点公立医疗机构与民营医疗机构医保药品执行相同的支付标准，定点零售药店医保支付标准统一按医疗机构支付标准上浮15%。