Health Insurance Bureau: For advice on the price of medicines and the recruitment of credit.

On August 20th, the Medical Network, August 19th, the National Health Insurance Administration's Pharmaceutical Price and Tender Procurement Guidance Center studied and drafted the Operational Specifications for Pharmaceutical Prices and Recruitment Credit Evaluation (Draft for Comments) and the "Discretionary Benchmark for Pharmaceutical Prices and Recruitment Credit Ratings (Draft for Comments) ", which are now open to the public for comments.
members of the public may submit their comments and suggestions by 2 September 2020, available in writing or by e-mail.
:()、、:,,,,《》(〔××××〕××),。
, the list of credit evaluation catalogues (i) the scope of evaluation.
Pharmaceutical enterprises (including pharmaceutical and medical supplies manufacturing enterprises, distribution enterprises, the same below) in the process of pricing, marketing, bidding, performance process to implement 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, violations of contract agreements, disrupt the centralized procurement order.
(ii) list of directories.
the specific matters included in the scope of pharmaceutical price and credit evaluation shall be managed in the catalogue, and the categories and circumstances of the items shall be listed.
the National Health Insurance Administration to develop and publish the "Pharmaceutical Prices and The List of Credits" and dynamically adjust them.
(iii) made public in the first place.
Central procurement agencies shall, from the date of the establishment of the pharmaceutical price and credit evaluation system, publish a list of the list of unsymrising matters 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 trustworthy commitments.
, pharmaceutical enterprises to abide by the commitment (i) the scope of application.
Pharmaceutical enterprises participating in or entrusting to participate in centralized procurement of pharmaceutical and medical supplies, platform networking, and medical insurance fixed-point medical institutions (hereinafter referred to as "medical institutions") for the record procurement, shall make a written and trustworthy commitment to the centralized procurement institutions.
(ii) the subject of the commitment.
1. Pharmaceutical enterprises with independent legal personality, as the main body of the registration, winning bid or distribution of pharmaceutical products, as well as the subject of commitment and the subject of responsibility for loss of trust.
2. Subsidiaries of pharmaceutical enterprises with independent legal personality may act as the main body of commitment.
breach of trust by a subsidiary does not automatically extend to the parent company and other subsidiaries.
3. The pharmaceutical enterprises described include license holders of pharmaceutical production, pharmaceutical and medical supplies manufacturers, distribution enterprises with agency relationship with production enterprises, and distribution enterprises.
, the holder of the drug listing license includes the domestic agent designated by the holder of the overseas drug listing license.
(iii) commitments.
of the pharmaceutical enterprises includes, but is not limited to, the following matters: 1. Commitment pricing, marketing, bidding, performance process does not occur in the list of non-trustworthy matters listed.
2. Whoever undertakes to commit a breach of trust or seek trading opportunities or competitive advantage for his own medicine or medical supplies for his own medicine or medical supplies shall be liable for breach of trust.
. In the event of a commitment to the act of disrepation, the appropriate measures shall be accepted.
(iv) the way of commitment.
1. Pharmaceutical enterprises formally sign and submit to centralized procurement agencies the "Pharmaceutical Enterprise Price and Marketing Behavior Credit Commitment", as detailed in Annex 1.
2. For pharmaceutical enterprises that have not submitted their commitments, the provincial centralized purchasing agencies shall not accept their drugs or medical supplies to be lying online, bidding, or other means of selling medicines or medical supplies to medical institutions.
3. Keeping the promise is the pharmaceutical enterprise to its own price behavior, business behavior to make the overall commitment, in principle, does not require pharmaceutical enterprises according to specific products, specific procurement activities respectively commitment, repeated commitment.
4. After receiving the written commitment of the enterprise, the centralized purchasing agency shall keep it in accordance with a certain number.
labeling rule is area code, enterprise number, and time.
of these, the area code part is 3 bits, the end is added 1 bit and unified to 0, the enterprise number section uses the enterprise's "unified social credit code", and the time section is uniformly numbered according to the way of year/month/day (YYYY/MM/DD).
(v) commitment cycle.
Pharmaceutical enterprises keep their promises without a fixed validity period, there are the following circumstances, the need to re-commit to the centralized procurement agency in writing: 1. the commitment party due to asset restructuring, enterprise name change, production license holding relationship change or product transaction relationship changes and other reasons, need to change the subject of the commitment.
2. The subject of the commitment shall remain unchanged and the legal representative of the subject of the commitment shall be changed.
3. If the promised province has no hanging network or winning drugs, medical supplies, or the network or winning drug, medical supplies without platform procurement record for more than 1 year, the written commitment shall be resubmitted before re-applying for the bid to hang up the net.
4. Other circumstances in which a renewed written commitment is necessary.
third, the record of the report of the information of the loss of trust (1) the active report of pharmaceutical enterprises.
1. Reporting body: As the responsible subject of active reporting, the pharmaceutical enterprise submitting the commitment shall voluntarily report the loss of trust information to the centralized purchasing institution where the loss of trust occurred for the enterprise itself and its employing personnel and entrusted agent enterprises for the loss of trust belonging to item 1-4 of the List of Pharmaceutical Prices and Recruitment of Unconscionable Matters (2020 Edition).
2.:《》(〔××××〕××),、,、、,(),。
In the case of commercial bribery in medicine, the information reported includes, but is not limited to, the products and amounts involved, the outcome of the case and the judgment, the enterprises and personnel involved, etc., and in the case of commercial bribery, the "kickbacks" of the products or medical supplies involved (hereinafter referred to as "products involved") should be detailed, including the object, amount, manner, source of funds, single drug or medical supplies "kickbacks" as a percentage of the retail price, etc.
. Reporting requirements: Pharmaceutical enterprises shall, within 20 days from the date of service of the court decision or the decision on administrative punishment of the department, provide a written report to the centralized procurement agency at the place where the case occurred.
the object of a judgment or administrative penalty is a proxy enterprise, the time limit for written reporting may be extended to 30 days.
pharmaceutical enterprises shall report information in a timely, comprehensive, complete and standardized manner, and shall not be concealed, underreported or not reported.
pharmaceutical enterprises shall appeal against the judgment or decision on administrative punishment or administrative reconsideration or administrative proceedings, and shall not affect their reporting of the information of the loss of trust to the centralized purchasing institution where the act of misre trust occurs.
(2) centralized collection by procurement agencies.
1. Collection body: centralized procurement agencies.
2. Collection: Items listed in the list of matters of disrepation.
3. Collection methods: those involved in commercial bribery of pharmaceuticals, the implementation of monopoly acts, prices and tax-related violations, at the same time as accepting the collection of information on the loss of trust reported by pharmaceutical enterprises, take the initiative to comb and summarize the judicial documents, administrative penalty decision documents and other relevant departments at all levels, collect and record the products and amounts involved in the province, the cause and judgment results, the enterprises and personnel concerned and other information.
such as court judgment documents published on the adjudication documents network, tax treatment decisions disclosed on the website of tax authorities or decisions on tax administrative penalties.
disclosure of information in public documents is incomplete, it should communicate with relevant authorities and departments in a timely manner to seek information support.
Where a pharmaceutical enterprise violates the rules of price, bidding and hanging up the internet, violates the promise of trustworthy and the contract for purchase and sale, and disturbs the order of centralized procurement of medicines and medical supplies, the centralized purchasing institution shall strengthen the daily monitoring and acceptance of complaints, and, if necessary, grasp and record the information by means of correspondence, interviews, etc.
(iii) to establish a database of information 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, horizontal sharing of information base.
the format in which the information is uploaded can be found in Annex 2.
, the credit rating of the act of dereliction of trust (1) the main body of the rating.
1. Credit ratings shall be carried out on a provincial level, and shall be implemented by the province's centralized procurement agencies and shall be subject to the guidance and supervision of the provincial medical security departments.
2. In the case of inter-provincial alliance procurement, the application rules for credit rating results produced by pharmaceutical enterprises in individual member provinces may be set out in the Alliance procurement rules, but the credit rating results of pharmaceutical enterprises in individual member provinces should not be automatically extended to all member provinces of the Alliance.
(ii) the discretionary benchmark.
Credit rating according to the nature of the act of bad faith, circumstances, time-limited, and the scope of influence and other factors, the pharmaceutical enterprises in the local tender procurement market, the failure of trust as "general", "medium", "severe", "particularly serious" four ratings, the specific discretionary benchmark issued by the unit separately.
(iii) rating method.
method of evaluating the price of medicine and recruiting credit rating is to evaluate the credit rating of specific acts, and then to determine the credit rating of the subject of the loss of trust according to the credit rating of each behavior.
1. Summarize the relevant acts of dis trustlessness in the body of commitment.
2. Rating each act of disrepation in accordance with the discretionary benchmark.
3. The results of credit evaluation are determined comprehensively according to the rating rating of each act of disrepation.
that is, the assessment of the rating has a progressive and progressive relationship between the different acts of disrepair, in accordance with the provisions of the discretionary benchmark, and again to complete the conversion of the different acts of disrepair, choose the highest rating of the credit rating, as the commitment subject of the current credit rating results.
4. Local credit rating methods for quantitative scoring can be explored on the basis of operating practices and discretionary benchmarks.
(iv) rating requirements.
Credit rating is based on facts limited to the loss of trust occurred within the scope of the province, the province has not occurred in the act of disrepation, credit failure rating in other provinces as the results of the province's credit evaluation, included in the "National Pharmaceutical Prices and The Risk Warning List of enterprises that have lost their trust."
(v) rating cycle.
credit ratings are dynamically updated and rolled out.
1. Provincial centralized procurement agencies update the results of credit evaluation on a quarterly level.
2. If the results of the credit rating change, the normal disclosure and continuation of the corresponding disposal measures.
3. If there is a change in the results of the credit rating, only the pre-release of the enterprise being evaluated will be made in the current period, so as to facilitate the enterprise to check, correct, appeal and rectify.
update the next quarter, disclose the official credit rating results and take simultaneous disposal measures.
, the disposition of the liability for loss of trust (1) shall take disposal measures in accordance with the grade grade.
1. For pharmaceutical enterprises rated as "normal" by the centralized procurement agency, written warnings shall be given.
2. For pharmaceutical enterprises rated as "medium" for loss of trust, in addition to warnings and caveats, the risk of loss of trust information of the purchasing object shall be automatically prompted when a medical institution places an order for the purchase of medicines or medical supplies produced and distributed by the enterprise.
3. For pharmaceutical enterprises rated as "severe" for creditworthiness, in addition to warning and warning of risks, the enterprise shall suspend the products involved in the network, bidding or distribution qualifications, 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, all pharmaceutical and medical supplies of the enterprise shall be suspended, 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 related information of the enterprise to the public and are subject to 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 taken to deal with them at a grading level shall take into account the access.
1. Where the supply structure of drugs or medical supplies is single and the supply and demand situation is tight, it means that the drugs or medical supplies involved have the following characteristics at the same time: First, they belong to the exclusive production and have been distributed for 3 consecutive months at a rate of less than 30%.
is irreplaceable, and stopping the supply will lead to the lack of clinical treatment or the inability of clinical treatment options to be implemented.
is of great therapeutic value, and stopping supply will seriously affect the safety of patients' lives.
2. If the drugs or medical supplies in question meet the characteristics mentioned in the previous paragraph, it shall not affect the taking of written warnings, warning to the purchaser of risk information, public disclosure of information on the public and other disposal measures.
3. Where the drugs or medical supplies involved meet the characteristics mentioned in the previous paragraph and are not suitable for suspension of the network, tender or distribution qualification, alternative measures may be taken on the basis of the confirmation of the evaluation of clinical opinions, such as postponing the suspension of the network, bidding or distribution qualifications to other enterprises to meet the supply, or requiring enterprises to stabilize the supply of medicines or medical supplies at lower historical prices before the occurrence of the act of disrepation.
(iii) included in the "National Pharmaceutical Prices and Recruitment of Lost Trust Enterprise Risk Warning List."
1. In the previous year, if five or more provinces were assessed as "particularly serious" for the loss of trust, the unit will be summarized in the National Pharmaceutical Price and Risk Warning List for Enterprises That Have Lost Trust, and the results of the previous year's credit rating will be published in the first quarter of each year.
2. If the credit rating results of the relevant enterprises in the province have been "serious" and "particularly serious", the credit rating results may not be further adjusted because they are included in the National List of Risk Warnings for Pharmaceutical Prices and Enterprises with Lost Trust.
3. If the credit rating result of the relevant enterprises in the province is "medium" or "medium" or below, it is included in the National Pharmaceutical Price and Recruitment of Unconstitional Enterprises.