Latest! The Health Insurance Administration issued two drafts for comments on pharmaceutical prices and credit.

Today (August 19), the National Health Insurance Administration's Guidance Center for Pharmaceutical Prices and Tendering and Purchasing studied and drafted the Code of Practice for the Evaluation of Pharmaceutical Prices and Credits (Draft for Comments) and the Discretionary Benchmark for Pharmaceutical Prices and Credit Ratings (Draft for Comments), and is now open to the public for comments.
public may make comments and suggestions by 2 September 2020, available in writing or by e-mail.
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, credit evaluation directory list (i) evaluation scope.
Pharmaceutical enterprises (including pharmaceutical and medical supplies production enterprises, distribution enterprises, the same between 2) pricing, marketing, bidding, performance process in the implementation of laws and regulations prohibited, contrary to good faith and fair competition to obtain improper benefits, such as in the purchase and sale of medicines to give kickbacks or other improper benefits (hereinafter referred to as "pharmaceutical commercial bribery"), the implementation of monopoly acts, price and tax-related violations, breach of contractual agreements, disrupt the centralized procurement order.
(ii) directory list.
of specific matters to be included in the scope of pharmaceutical prices and credit evaluation shall be managed in the catalogue, and the categories and circumstances of the matters shall be listed.
the National Health Insurance Administration to formulate and publish the "list of medical prices and recruitment of mis-trusted matters" and dynamic adjustment.
(iii) to be made public in front of time.
Centralized purchasing institutions shall, from the date of establishing the system of evaluation of pharmaceutical prices and credit for recruitment, publish a list of matters of loss of trust through official websites, information platforms and other public channels, so that pharmaceutical enterprises can fully understand the specific requirements of pharmaceutical prices and credit evaluation before submitting their commitments.
, pharmaceutical enterprises to keep their promises (1) the scope of application.
Pharmaceutical enterprises that participate in or entrust themselves to participate in the centralized procurement of pharmaceutical and medical supplies, the platform network, and the record-keeping procurement carried out by medical insurance designated medical institutions (hereinafter referred to as "medical institutions") shall make a written and committed commitment to the centralized purchasing institutions.
(ii) commitment subject.
1. Pharmaceutical enterprises with independent legal personality, which are the subject of the registration, winning bid or distribution of pharmaceutical products, as well as the subject of commitment and the subject of responsibility for failure of trust.
2. Subsidiaries of pharmaceutical enterprises with independent legal personality may act as the subject of commitment.
breach of trust by a subsidiary does not automatically extend to the parent company and other subsidiaries.
3. The pharmaceutical enterprises called include drug production license holders, pharmaceutical and medical supplies production enterprises, distribution enterprises with which the production enterprises have a principal-agent relationship, and distribution enterprises.
, the drug listing license holder includes the domestic agent designated by the overseas drug listing license holder.
(iii) commitment matters.
pharmaceutical enterprises to keep their promises, including, but not limited to, the following: 1. Commitment pricing, marketing, bidding, performance in the process of non-compliance list of acts.
2. Undertake to bear the liability for breach of trust if its employees, entrusted agent enterprises, commit acts of breach of trust for their own medicines or medical supplies, and seek trading opportunities or competitive advantage for their own medicines or medical supplies.
3. In the event of a commitment to a failure of trust, appropriate measures are accepted.
(iv) the manner of commitment.
1. Pharmaceutical enterprises formally signed and submitted to centralized procurement agencies "pharmaceutical enterprises price and marketing behavior credit commitment", as detailed in annex 1.
2. For pharmaceutical enterprises that have not submitted a letter of commitment, the centralized purchasing agencies at the provincial level shall not accept their medicines or medical supplies to be online, bid for, or otherly sell medicines or medical supplies to medical institutions.
3. Keeping the promise is the overall commitment of pharmaceutical enterprises to their own price behavior and business behavior, and in principle, pharmaceutical enterprises are not required to make separate commitments and duplicate commitments according to specific products and specific procurement activities.
. After receiving the written commitment of the enterprise, the centralized purchasing agency shall keep it according to a certain rule number.
number rule is the area code, the enterprise number, and the time.
, the area code part is 3 bits, the end is added 1 bit and unified 0, the enterprise number part uses the enterprise's "unified social credit code", and the time part is uniformly numbered according to the year/month/day (YYYY/MM/DD).
(v) commitment cycle.
Pharmaceutical enterprises keep their promises without a fixed validity period, and if the following circumstances exist, it is necessary to re-make a written commitment to the centralized purchasing institution: 1. The committed party needs to change the commitment subject due to various reasons such as asset reorganization, change of name of the enterprise, change of production license holding relationship or change of product transaction relationship.
2. If the subject of the commitment remains unchanged and the legal representative of the subject is committed to change.
3. If there is no registered or winning drug, medical consumables, or a registered network or a winning drug or medical consumables without a platform procurement record for more than 1 year, the written commitment shall be resubmitted before reapplying for the bid to be registered.
other circumstances in which a written commitment is indeed necessary.
, the loss of trust information report records (1) pharmaceutical enterprises to take the initiative to report.
1. Report subject: As the responsible subject of the active report, the pharmaceutical enterprise submitting the commitment shall, for the enterprise itself and its employees, and the entrusting agent enterprise, have acted in bad faith under item 1-4 of the List of Medical Prices and Recruitment of Misconduct (2020 Edition), and has taken the initiative to report the misrelievity information to the centralized purchasing agency where the loss of trust occurred.
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Taking pharmaceutical commercial bribery as an example, the information reported includes, but is not limited to, the products and amounts involved, the cause and judgment of the case, the enterprises and personnel involved, etc.;
. The report requires that pharmaceutical enterprises shall, within 20 days from the date of service of the court's decision or the administrative penalty decision of the department, provide written reports to the centralized purchasing agency at the place where the case occurred.
of the written report may be extended to 30 days if the target of the judgment or administrative penalty is the entrusted agent.
pharmaceutical enterprises shall report information in a timely, comprehensive, complete and standardized manner, and shall not be concealed, underreported or unreported.
pharmaceutical enterprises to appeal judgments, administrative penalty decisions or administrative review, administrative proceedings, does not affect its reporting of the loss of trust information to the centralized procurement agencies where the misconduct occurred.
(ii) centralized procurement agencies to collect.
1. Acquisition subject: centralized procurement agencies.
2. Collecting content: matters listed in the catalogue of matters of loss of trust.
3. Collection methods: Those involved in commercial bribery of medicine, the implementation of monopoly acts, prices and tax-related violations, while accepting and collecting the information of the failure of trust reported by pharmaceutical enterprises, take the initiative to comb and summarize the judicial documents, administrative penalty decision documents, etc. made public by the people's courts at all levels, the market supervision bureau, the tax bureau and other relevant departments, and collect and record the products and amounts involved in the case, the cause and judgment, the enterprises and personnel concerned within the province.
such as court judgment documents published by the adjudication documents network, tax treatment decisions disclosed on the tax authorities' websites, or decisions on tax administrative penalties.
if the disclosure of public document information is incomplete, it should communicate with relevant organs and departments in a timely manner to seek information support.
Where a pharmaceutical enterprise violates the rules of price, bidding and networking, violates a trustworthy commitment and purchase and sale contract, or disturbs the centralized procurement order of medicines and medical supplies, the centralized purchasing agency shall strengthen daily monitoring and reporting of complaints, and, if necessary, grasp the information and record it through correspondence, interviews, etc.
(3) to establish an information bank on the price of pharmaceutical enterprises.
centralized procurement agencies regularly upload information on the price of pharmaceutical enterprises to the information system designated by the unit, forming a vertical collection and horizontal sharing of information base.
the format in which the information was uploaded can be found in Annex 2.
, the act of disrepair credit rating (1) rating subject.
1. The credit rating shall be carried out on a province-by-province level, and shall be implemented by the centralized purchasing agencies of the province, and shall be subject to the guidance and supervision of the provincial medical security departments.
2. When inter-provincial alliance procurement is implemented, the application rules for credit rating results produced by pharmaceutical enterprises in individual member provinces may be set out in the union procurement rules, but the credit rating results of pharmaceutical enterprises in individual member provinces shall not be automatically extended to all member provinces of the alliance.
(ii) discretionary benchmark.
The credit rating shall be rated as "general", "medium", "severe" and "particularly serious" according to the nature, circumstances, limitations, and scope of influence of the pharmaceutical enterprises in the local bidding and procurement market, and the specific discretionary benchmark shall be issued separately by the unit.
(iii) rating method.
basic method of evaluating pharmaceutical prices and credit rating is to evaluate the credit rating of specific behavior first, and then to determine the credit rating of the credit score of the unreal subject according to the credit rating of each behavior.
1. Summarize the relevant acts of disreals in the unit of the commitment subject.
2. Rating each act of disrepair according to the discretionary benchmark.
3. The results of credit evaluation shall be determined comprehensively according to the rating of each act of disrepair.
That is, the assessment of the rating has a progressive relationship between the different acts of disrepair, in accordance with the provisions of the discretionary benchmark for conversion;
4. Local credit rating methods for quantitative scoring can be explored on the basis of operational specifications and discretionary benchmarks.
(iv) rating requirements.
The credit rating is limited to matters of disrelieving within the scope of the province, and if the province has not acted in disrelieving, the credit rating of the province shall not be taken as the result of the credit evaluation of the province, except in the National Warning List of Pharmaceutical Prices and Risks of Recruitment of Unreliable Enterprises.
(v) rating cycle.
credit ratings are dynamically updated and rolled out.
. The results of the credit evaluation are updated quarterly by the provincial centralized procurement agencies.
2. If the credit rating results change, the corresponding disposal measures are normally disclosed and continued.
. If the credit rating results change, only the pre-release of the direction of the enterprise being evaluated shall be made in the current period, so as to facilitate the enterprise to check, correct, appeal and rectify.
the next quarter of the dynamic update, disclose the official credit rating results, and take simultaneous measures to deal with.
, the responsibility for failure of trust graded disposal (1) according to the grade classification to take disposal measures.
1. For pharmaceutical enterprises rated as "general" for loss of trust, a written reminder shall be given by the centralized purchasing agency.
2. For pharmaceutical enterprises rated as "moderate" for loss of trust, in addition to warnings, the risk information of the failure of the purchase object shall be automatically prompted when the medical institution places an order for the purchase of medicines or medical supplies produced or distributed by the enterprise.
3. For pharmaceutical enterprises rated as "serious" for loss of trust, in addition to warning and warning of risks, the enterprise involved in the product registration, bidding or distribution qualifications shall be suspended, the suspension period shall be based on the credit repair of pharmaceutical enterprises, grade changes.
4. For pharmaceutical enterprises rated as "particularly serious", in addition to warning and warning of risks, the enterprise shall suspend all pharmaceutical and medical supplies hanging network, bidding or distribution qualifications, the suspension period shall be based on the pharmaceutical enterprises to repair credit, rating results changes.
5. For pharmaceutical enterprises rated as "severe" and "particularly serious", the provincial centralized procurement agencies regularly disclose the results and relevant information of the enterprise's rating to the public and accept social supervision.
(2) If the supply structure of drugs or medical supplies involved is single and the supply and demand situation is tight, the measures of graded disposal shall take into account the accessability.
1. If the supply structure of related drugs or medical supplies is single and the supply and demand situation is tight, it means that the drug or medical supplies involved have the following characteristics at the same time: First, they belong to exclusive production and have been distributed for 3 consecutive months at a rate of less than 30%.
is irreplaceable, the cessation of supply will lead to the lack of clinical treatment methods or clinical treatment options can not be implemented.
is of great therapeutic value, the cessation of supply will seriously affect the safety of patients.
2. If the drugs or medical supplies in question conform to the characteristics described in the previous paragraph, they shall not affect the disposal measures such as taking written warnings, alerting the purchaser to risk information, and disclosing the information of loss of trust to the public.
3. If the drug or medical supplies in question meet the characteristics described in the previous paragraph and are not suitable for suspension of the registration, bidding or distribution qualification, alternative measures may be taken on the basis of consultation and confirmation of clinical opinion assessment, such as delaying the disposal measures of suspending the network, bidding or distribution qualifications until other enterprises can meet the supply, or requiring the enterprise to provide stable supply of medicines or medical supplies at a lower historical price before the loss of trust occurs.
(3) is included in the National Warning List of Pharmaceutical Prices and Risks of Enterprises That Have Lost Trust.
1. In the previous year, if a person is assessed as "particularly serious" for loss of trust by five or more provinces, the unit will be included in the National Warning List of Risks of Pharmaceutical Prices and Creditless Enterprises, and the results of the previous year's credit rating shall be published one time in the first quarter of each year.
2. If the credit rating results of the relevant enterprises in the province have been "severe" or "particularly serious", the credit rating results of the credit rating adjustment should not be further adjusted because they are included in the "National Warning List of Pharmaceutical Prices and Risks of Enterprises That Have Lost Trust".
. If the credit rating results of the relevant enterprises in the province are "medium" or "medium" or below, they are included in the "National Drug Price and Risk Warning Name for Enterprises That Have Lost Trust".