Six key words in the new stage of centralized procurement!

At the beginning of the new year, centralized procurement with volume is still an important starting point for the new medical reform, especially the "three medical linkage" reform with medical insurance as the main line
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The "Opinions on Promoting the Normalization and Institutionalization of the Centralized and Volume-Based Procurement of Medicines" (Guoban [2021] No.
2 Document) (hereinafter referred to as "No.
2 Document") issued at the end of January 2021 marked the experience of centralized and volume-based procurement.
After the exploration of joint procurement by national organizations and the extensive pilot projects of inter-provincial alliances, provincial centralized procurement, municipal alliances, and municipal centralized procurement in various provinces and cities, it has entered a new stage.
2022 is the key implementation period
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From "Exploration and Pilot" to "Normalization and Institutionalization" In November 2018, the "National Organization for Centralized Drug Procurement Pilot Program" was reviewed and approved, which opened the prelude to a new stage of China's centralized drug procurement
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In 2019, the National Medical Insurance Administration actively carried out the "4+7" pilot program and "expanded" two rounds of centralized procurement of 25 varieties; Procurement; In January 2021, the State Council executive meeting further deployed requirements to promote the normalization and institutionalization of centralized drug procurement
.
Document No.
2 was issued under this background - from the national level, it summarizes the previous experience of the National Medical Insurance Bureau and local procurement exploration and pilot experience, and provides the coverage and procurement of the next national joint procurement and local centralized procurement.
Rules, safeguard measures, supporting policies, organizational safeguards, etc.
put forward new normative requirements
.
It is important to point out that Document No.
2 is for the "Guiding Opinions on Improving the Centralized Procurement of Medicines in Public Hospitals" (Guobanfa [2015] No.
7) and the "Notice on Implementing the Guiding Opinions on Improving the Centralized Procurement of Medicines in Public Hospitals" (Guowei Yaozhengfa [2015] No.
70) to further improve and deepen the "classified procurement, step-by-step implementation"
.
After the No.
2 document was issued, the National Medical Insurance Bureau launched the fourth and fifth batches of national drug joint procurement (respectively involving 45 and 61 products) in February and June last year; the sixth batch of insulin special procurement was launched in November of that year ( involving products 16)
.
Six batches and seven rounds of national procurement involved a total of 234 products
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According to reports, the average price reduction is more than 50%, and the maximum price reduction is more than 99%.

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In response to the four pain points of "checkout, quantity, hospital admission, and use" that restricted centralized procurement in the past, new standard requirements and methods were adopted, and a good price reduction effect was received
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After three years of exploration by the National Medical Insurance Administration, the joint procurement rules have been continuously improved and iterated
.
For example, from exclusive selection to multiple selections; established rules such as 50% reduction, 1.
8 times the price limit, 0.
10 yuan shortlist, etc.
; selected markets according to the order of the selection price, etc.
, the rules of the state's organization of procurement with volume are basically formed
.
In the "Guiding Opinions on Establishing a Pharmaceutical Price and Recruitment and Procurement Credit Evaluation System" (Medical Insurance Fa [2020] No.
34), the provision of rebates or other illegitimate benefits in the purchase and sale of pharmaceuticals, tax-related violations, price monopoly, and unfair prices Strict requirements are put forward for behaviors that are contrary to good faith, such as behaviors, illegal bidding, and malicious breach of contract agreements
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After that, the "Notice on Accelerating the Implementation of the Medical Price and Recruitment and Procurement Credit Evaluation System" (Medical Insurance Ban Fa [2020] No.
59) was posted online
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As of December 31, 2020, all provinces and cities have issued relevant documents
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In April 2021, the Zhejiang Provincial Center for Pharmaceutical Devices issued the "Notice on the Evaluation Results of Pharmaceutical Prices in Our Province and Discredited Recruitment and Procurement", and also used the new rules of credit evaluation to make a "serious" evaluation of the credit of an enterprise, and canceled it.
Its qualification to hang on the Internet marks that the new system has entered the implementation stage
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At present, more than 20 untrustworthy enterprises have been published on the website of the National Medical Insurance Administration
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The author noticed that in the "14th Five-Year Plan for National Medical Insurance" (Guobanfa [2021] No.
36) issued in September last year, the focus of China's medical insurance reform in the next five years was outlined, and it was proposed to normalize and institutionalize the implementation of national medical insurance.
Organize centralized procurement with volume, and continue to expand the scope of centralized procurement of high-value medical consumables organized by the state; strengthen unified guidance to centralized procurement agencies, standardize local centralized procurement with volume, and form national, provincial, and cross-regional alliance procurement.
Collaborative work pattern and other requirements
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It also clarified the quantitative indicators of the progress of centralized procurement - by 2025, the amount of drugs purchased by the provinces (autonomous regions and municipalities) at the national and provincial levels should be ≥ 90%, and the number of varieties should be ≥ 500; the amount of medical consumables should be ≥ 80%, and the variety Number ≥ 5 categories
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In October 2021, after the promulgation of the "Implementation Opinions on Further Promoting the Experience of Sanming City, Fujian Province and Deepening the Reform of the Medical and Health System" (Guojieaifa [2021] No.
2), the requirements for centralized procurement were refined as "purchasing drugs before the end of 2022.
" The number of generic names exceeds 300; by the end of the "14th Five-Year Plan", there will be more than 500; each province conducts or participates in the alliance's centralized procurement of medicines and consumables at least once each year; centralized procurement information must be uploaded to the national medical insurance information system in a timely manner
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In the new stage, the new standard implements the No.
2 document.
So far, no less than 18 inter-provincial alliance procurement organizations have been formed; improve the provincial platform Sunshine online procurement system, standardize the rules for hanging and withdrawing the network, and promote information linkage, Gradually realize that all public medical institutions purchase required medicines and medical consumables from provincial platforms; implement the policy of retaining medical insurance fund balances, and encourage medical institutions and medical personnel to use the selected products rationally, and more than ten provinces have issued documents
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Regarding the relevant requirements of centralized procurement, the new specifications can be summarized as the following keywords: procurement with volume, government organization, alliance procurement, all-in-one procurement, one product, one policy, three-level operation, unified platform, standardized grouping, dosage form merger, adaptation Symptoms or functions are similar to merger, quality priority, fair price, common name payment, priority overuse, information sharing, credit evaluation, etc.

This article focuses on the interpretation of the six keywords
.
1.
Procurement with volume The essence is to beat the price by volume, low price for large volume, high price for small volume, and combination of price and price.
Obviously, it is not the first time that Document No.
2 has been proposed, but the implementation effect has been uneven
in various places in the past five years.
The idea of ​​"alliance procurement, platform operation" starts from the determination of quantity, the selection of methods, the settlement of hospital use, incentives and supervision and management.
It has played a real role in reducing the selected price
.
2.
It should be purchased as much as possible.
Document No.
2 proposes that "focus on the centralized purchase of medical insurance products with large clinical usage and high purchase amount by category.

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Gradually cover all kinds of medicines that are clinically necessary and of reliable quality on the domestic market, and make sure that all the medicines should be collected
.
” Combined with the various documents recently released by the National Medical Insurance Bureau, it can be understood that “all the medicines should be collected” means that by 2025, the medical insurance will be taken up.
90% of all drugs and 80% of all consumables of the fund will be included in the scope of centralized procurement
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This is an institutional arrangement based on "strategic purchase of medical insurance", which is more accurate and more accurate than the previous inclusion of all public hospital varieties in centralized procurement.
Easy to operate
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In the next 2 to 3 years, as more varieties enter the scope of procurement with volume, the product pattern will undergo great changes
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3.
Alliance procurement From the current pilot program of centralized procurement with volume in the country, the methods of alliance procurement include national procurement alliances, Such as the joint procurement of six batches of national drugs, two batches of high-value medical consumables, etc.
; inter-provincial procurement alliances, such as Beijing-Tianjin-Hebei procurement alliance, Shaanxi inter-provincial alliance, Henan inter-provincial alliance, etc.
; inter-provincial and prefecture-city procurement alliances, such as Sanming Alliances; Procurement Alliances in Inland Provinces and Cities, such as Shandong, Shanxi, Anhui, Jiangsu Prefecture-City Alliances, etc.

Under the encouragement and guidance of policies, there may be alliance procurement of different levels and more quantities in the future, and more types of alliances may be explored.
4.
Unified Rules In the
past two years, the procurement of drugs with quantity in various provinces and cities has been piloted from different dimensions, with different methods and methods, mainly reflected in evaluation methods, quantity determination, selection rules, price limit, and price negotiation.
Pharmaceutical companies are overwhelmed in such aspects as stratification, grouping, distribution, medical insurance payment, settlement, etc.

In response to the above problems, Document No.
2 makes uniform requirements, and does not set up quality groups for generic drugs, original research drugs and reference preparations that have passed the consistency evaluation.
, and directly carry out centralized and volume-based procurement under the generic name of the competitive unit; for drug varieties that have not been covered by the consistency evaluation, it is necessary to clarify the procurement quality requirements, and explore the establishment of a comprehensive evaluation system for clinical use based on big data.
More than 2; combine different dosage forms, specifications, packaging and purchase quantities of drugs with the same generic name with similar clinical efficacy in the same route of administration; explore the merger of different generic drugs with similar indications or functions to carry out centralized procurement with volume, etc.

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At the same time, it is also proposed to strengthen the standardized construction of centralized drug procurement platforms, unify basic operating rules, work processes and standards for drug online and withdrawal, unify the classification and codes of medical insurance drugs, and unify drug procurement information standards
.
5.
Three-level operation "Three-level operation" means that the country, the province, the prefecture and the city each perform their own duties and are responsible for the division of labor
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That is, the state organizes centralized and volume-based procurement of some drugs that have passed the consistency evaluation, conducts special procurement according to market conditions, and guides local governments to carry out procurement work
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Each province (autonomous region, municipality directly under the Central Government) conducts centralized and volume-based procurement of medicines within the region other than the scope of centralized procurement by the state organized by the state or forms alliances with other provinces to carry out centralized and volume-based procurement, and guide qualified prefecture-level and city-level overall planning areas to carry out procurement work
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The prefecture-level co-ordination areas shall, according to the arrangements of the provinces (autonomous regions and municipalities directly under the Central Government), conduct centralized and volume-based procurement independently or form alliances with other regions for drugs outside the scope of centralized volume-volume procurement by the superior organization
.
6.
Fair price Circular No.
2 clearly states in the selection rules clause: the selection of companies and the selection of prices will be generated through quality and price competition; if there are multiple selection companies for the same generic drug, the price difference should be fair and reasonable
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The expression "fair" in price is the first time that it has appeared in the documents of centralized drug procurement in the past few years.
At the executive meeting of the State Council on January 15, it was further proposed that "centralized procurement should reduce the burden on patients and take into account the reasonable profits of enterprises".
request
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Although there is currently no detailed explanation about the "fair and reasonable" price, please refer to the "Operation Specifications for Pharmaceutical Price and Recruitment Credit Evaluation" issued by the Price and Bidding Guidance Center of the National Medical Security Administration in November 2020, "Medical Price and Recruitment Credit Evaluation" The description of "price anomalies" in the "Based on Discretionary Benchmarks" can be more accurately understood
.
It can be predicted that the centralized procurement in the future will not be based on price theory
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From the renewal of the first to the third batch of domestically harvested varieties in 2021, it can be observed that the rules have become more moderate and the prices of some products have rebounded
.