The reform of medical insurance further promotes the pharmaceutical industry to respond to the trend

At present, the reform of China's medical security system has entered a stage of system integration, coordination and efficiency, and the role of the medical security department has also transformed from a post-payer to a strategic buyer
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2021 is the first year of the "14th Five-Year Plan", and medical insurance policies are intensively introduced
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This article sorts out this, and analyzes and predicts the impact on the pharmaceutical-related industry
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1 The promulgation and implementation of “One Regulation and Two Measures” and the solicitation of opinions on the Medical Security Law.
While grasping business opportunities for outflow of prescriptions, drug business enterprises should pay attention to the compliance of their business models.
, It is an inevitable requirement to promote the modernization of the medical security governance system and governance capacity
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On February 19, 2021, the first administrative regulation in the medical insurance field, "Regulations on the Supervision and Administration of the Use of Medical Insurance Funds" (hereinafter referred to as the "Regulations"), was released, and will come into force on May 1, 2021
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Two departmental regulations, the Interim Measures for the Designated Management of Medical Insurance in Medical Institutions and the Interim Measures for the Designated Management of Medical Insurance in Retail Pharmacies (hereinafter collectively referred to as the two regulations), were released on January 8, 2021, and will come into force on February 1, 2021
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Not only that, the "Medical Security Law (Draft for Comment)" drafted by the National Medical Security Administration will be open to the public for comments on June 15, 2021
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The "Regulations" make the supervision and management of the use of medical security funds legal, and expand and refine legal responsibilities
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The "Guiding Opinions on Improving the Agreement Management of Designated Medical Institutions of Basic Medical Insurance" clearly states that the qualification review of designated hospitals and designated pharmacies will be completely abolished, and the management of agreements will be improved
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The two regulations specify the scope, conditions, material requirements, organization evaluation, negotiation and negotiation of the designated medical institutions, as well as the circumstances of non-acceptance; it is clarified that “the application can be applied for at least 3 months after formal operation, and the evaluation time shall not exceed 3 months.
Months” and other requirements, simplify the application process and evaluation procedures, shorten the waiting time of medical institutions, and help expand the supply of medical resources
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The two regulations stipulate that Internet hospitals can rely on their physical medical institutions to apply for a supplementary agreement, and the relevant expenses incurred by the medical services they provide that meet the scope of medical insurance payment shall be handled by the coordinating regional handling institutions and the physical medical institutions they rely on in accordance with regulations.
settlement
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Designated retail pharmacies can sell medicines on the basis of electronic prescriptions issued by designated medical institutions, that is, allowing electronic prescriptions that meet the regulations to be transferred to physical pharmacies for collection or delivery by physical pharmacies
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But the circulation of prescriptions is not the same as selling prescription drugs online
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In November 2020, the General Department of the State Food and Drug Administration publicly solicited opinions on the "Measures for the Supervision and Administration of Drug Online Sales (Draft for Comment)"
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While grasping the business opportunities of prescription outflow, pharmaceutical companies need to pay attention to the compliance of their business models
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In addition, the "Regulations", the two prescribed measures and the "Medical Security Law (Draft for Comment)" all continue the "Letter of the Administrative Tribunal of the Supreme People's Court on the National Medical Security Administration" on the integration of medical insurance management service agreements into the management of administrative agreements.
The Reply Letter of "The Traditional Chinese Medicine Insurance Management Service Agreement is the characterization of the administrative agreement
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Recently, the first instance of the administrative litigation involving Yongjia Jiangnan Hospital v.
Zhejiang Yongjia County Medical Insurance Service Center came to an end
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In the future, administrative reconsideration and administrative litigation caused by disputes over medical insurance management service agreements will gradually increase
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2 The normalized and institutionalized development of centralized drug procurement with volume Under the new normal of centralized procurement, how the selected enterprises can ensure the supply of selected drugs and adapt to the new regulatory environment for centralized procurement of drugs is also an issue that needs to be paid attention to.
On January 28, 2021, the General Office of the State Council issued "Opinions on Promoting the Normalization and Institutionalization of the Centralized Procurement of Medicines with Volume"; on June 4 of the same year, eight departments including the National Medical Insurance Bureau issued the "Guiding Opinions on Carrying out the Centralized Procurement and Use of High-value Medical Consumables Organized by the State"
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After three years of hard work, the reform of centralized procurement with volume has entered a new stage of normalization and institutionalization
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Centralized procurement bidding regulation, quality, supply, distribution, and use of guarantee mechanisms and supporting policies are also increasingly improved and optimized
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Up to now, 6 batches of drug purchases have been carried out (the seventh batch of drug purchases was officially launched in February this year), a total of 234 kinds of drugs have been purchased, and the amount involved accounts for 30% of the total annual drug purchases of public medical institutions
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In 2021, centralized procurement will be carried out for high-value orthopaedic consumables, and special procurement of insulin will be carried out, expanding the centralized procurement to the field of biological drugs for the first time
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In addition, local governments have also carried out different forms of provincial and inter-provincial alliance centralized procurement while participating in the centralized procurement organized by the state
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From the perspective of procurement varieties, the local area is involved in the three major drug sectors of chemical drugs, proprietary Chinese medicines and biological drugs.
The two varieties of coronary balloon and ophthalmic intraocular lens have also achieved full coverage in the province
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It has become an inevitable trend to increase the speed of centralized procurement and expand coverage
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According to the regular briefing on the State Council's policy on February 11, by the end of 2022, the national organization and provincial alliance procurement will achieve the goal of covering more than 350 varieties of drugs and more than 5 varieties of high-value medical consumables per province on average
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Centralized procurement has had a profound impact on the marketing system and marketing strategies of pharmaceutical companies.
News of the abolition and diversion of the sales staff of the corresponding varieties of selected enterprises has continued to spread, and even the sales of product pipelines that are homogeneous with the centralized procurement varieties are also facing an impact
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The systems of centralized procurement and pharmaceutical prices and credit evaluation of recruitment and procurement will gradually form a synergy, which will fundamentally impact the traditional sales model with gold and help purify the market environment
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The normalization and institutionalization of centralized procurement also directly affects the choice of pharmaceutical companies' development strategies
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Judging from the data of selected varieties, centralized procurement has accelerated the substitution of domestic generic drugs for original research drugs, and the market share of original research patent expired drugs is facing shrinking
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Low-level homogeneous competition is not the way to survive.
China's generic drug market has entered the era of "price-for-quantity"
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Whether to actively embrace centralized procurement, or focus on market opportunities other than centralized procurement and out-of-hospital markets, or increase innovation efforts, or focus on developing OTC drugs that are less affected by policies, drug manufacturers need to make decisions or balance based on their own advantages.
problem
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In addition, under the new normal of centralized procurement, how the selected enterprises can ensure the supply of selected drugs and adapt to the new regulatory environment of centralized procurement is also an issue that needs to be paid attention to.

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In 2021, many pharmaceutical companies in centralized procurement will experience problems such as supply cuts or low distribution rates
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Pharmaceutical companies that plan to participate in centralized procurement should learn from experience and lessons, reserve sufficient time for post-marketing changes of drugs, and set up corresponding plans for abnormal supply chains and interruption of supply of raw and auxiliary materials
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The selected pharmaceutical companies should also be prepared to adapt to the strict supervision and inspection of the local drug regulatory authorities and the full coverage of the selected products
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3 Establish and improve the national medical insurance negotiation drug landing policy DTP pharmacies of leading pharmaceutical retail enterprises may become the main force to undertake the national negotiation drugs, ushering in development opportunities Guiding Opinions on the "Dual Channel" Management Mechanism of National Medical Insurance Negotiation Drugs" (hereinafter referred to as the "Guiding Opinions"); on September 10 of the same year, the "Notice on Adapting to the Normalization of National Medical Insurance Negotiations and Continuing to Do a Good Job in Negotiating Drugs" (hereinafter referred to as the "Notice"), which aims to improve the availability of medicines negotiated by the national medical insurance
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The policy on the implementation of drugs from the State Talk is undoubtedly good news for the drug manufacturers of the State Talk, especially those that are included in the "dual-channel" management and implement the separate payment policy
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The "Guiding Opinions" clearly states that "drugs subject to separate payment policies may not be included in the scope of total medical insurance control of designated medical institutions"
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The "Notice" pointed out that the reasonable allocation and use of negotiated drugs in designated medical institutions should be included in the content of the agreement and linked to the annual assessment
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Negotiated drugs that are paid separately are not included in the total amount of designated medical institutions
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This eliminates the concerns of medical institutions, and clears some obstacles for solving the "difficulty in hospital admission" of drugs
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In addition, the "dual-channel" management mechanism has included designated retail pharmacies into the scope of China's drug supply guarantee, expanding drug sales channels
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The national policy on drug landing also brings opportunities for powerful drug business enterprises
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If a pharmacy wants to undertake the nationally negotiated drug market brought about by the circulation of prescriptions, it needs to meet the software, hardware, personnel and management system requirements required by the "dual channel" policy of medical insurance.
It is difficult for general retail pharmacies to meet the conditions.

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The DTP pharmacies of the leading pharmaceutical retail enterprises may become the main force to undertake the drugs under the national talks, ushering in development opportunities
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4 The medical service price of the pilot medical service price reform will also be tilted towards the disciplines with insufficient medical supplies such as pediatrics, geriatrics, psychiatry, and rehabilitation.
Price Reform Pilot Program
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The plan calls for adhering to the people's health as the center, the clinical value as the guide, and the medical development law as the follow, to establish and improve medical service prices that adapt to economic and social development, better play the role of the government, fully participate in medical institutions, and reflect the value of technical labor services.
forming mechanism
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It is planned to explore and form a replicable and popularized experience in the price reform of medical services through a 3-5 year pilot program
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By 2025, the pilot experience will be rolled out nationwide
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The reform of medical service prices is an important factor affecting the sustainable and healthy development of China's medical and health services
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After the public hospitals fully implemented the "zero mark-up" of drug consumables, all localities took the transition of the compensation mechanism of public hospitals as the guide, and raised the service price mainly for technical labor services
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Centralized procurement squeezes the price water, objectively creating an opportunity for the reform of medical service prices
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The focus of this medical service price reform is to establish and improve a series of mechanisms such as price item management, total price management regulation, price classification formation, price dynamic adjustment, and price monitoring and assessment
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The ideal result of the reform is that the burden on the masses is generally stable, the medical insurance fund is affordable, and the healthy development of public medical institutions is sustainable
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From the perspective of the reform trend, there is still room for improvement in the prices of items that reflect the value of medical personnel’s technical labor services, such as diagnosis, surgery, nursing, and traditional Chinese medicine.
Disciplinary projects are skewed
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The inspection and treatment items with a high proportion of equipment depreciation will further reduce the price
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Hospitals with a high proportion of operating department business in their income structure will benefit more from price reform
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In addition, simplifying the application process for new price projects and speeding up the process of acceptance review is also expected to solve the current problems of slow pace, long procedures, and imbalance in the proportion of Chinese and Western medicine projects in medical institutions applying for new projects, and objectively promote medical technology innovation and clinical application.
effect
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5 The "14th Five-Year Plan" National Medical Security Plan was released.
During the "14th Five-Year Plan" period, "Internet + medical health" will be on the fast track of development.
On September 29, 2021, the General Office of the State Council issued the "14th Five-Year Plan" National Medical Security "Plan" (hereinafter referred to as the "14th Five-Year Plan"), which summarizes the achievements of the development of medical security during the "13th Five-Year Plan" period, and clarifies the roadmap for the construction of the medical security system, collaborative governance system, and service support system in the next five years.

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Since then, various provinces (autonomous regions and municipalities) have also successively released their local "14th Five-Year" medical security development plans
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Commercial insurance has been mentioned many times in the "14th Five-Year" medical insurance plan, which can be mainly summarized into three aspects
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First, the state regards commercial insurance as an important part of the multi-level medical security system.
By clarifying the liability boundary of basic medical insurance, it supports commercial insurance institutions to develop commercial health insurance products linked to basic medical insurance, and better covers basic medical insurance that does not pay costs
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The second is to encourage commercial insurance institutions to innovate products, provide comprehensive health insurance products and services in various fields such as medical treatment, disease, rehabilitation, nursing, and maternity, and gradually incorporate the application of new medical technologies, new drugs, and new equipment into the scope of commercial health insurance coverage
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Encourage the development of commercial long-term care insurance products
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Support commercial insurance institutions and traditional Chinese medicine institutions to cooperate in the development of health management services and the development of insurance products such as traditional Chinese medicine for the treatment of pre-diseases
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The third is to improve the professionalism, precision and efficiency of supervision through the introduction of commercial insurance
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Regulate commercial insurance institutions to undertake critical illness insurance business, introduce commercial insurance institutions and other third-party forces to participate in the supervision of medical insurance funds, and encourage commercial insurance institutions and other social forces to participate in handling management services
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Commercial insurance institutions should strengthen communication with medical security departments and seize development opportunities that are in line with policies
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Extending medical insurance management services to the field of "Internet + medical health" and forming a relatively complete "Internet + medical health" medical insurance policy system, service system and evaluation system are also the focus of the "14th Five-Year Plan" medical insurance plan
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The "14th Five-Year Plan" for medical insurance clearly states that it will support the orderly development of new models and new formats of medical and health services, such as telemedicine services, Internet diagnosis and treatment services, Internet drug distribution, and door-to-door nursing services, and promote the rational application of new technologies such as artificial intelligence; "Internet + medical health" medical insurance service fixed-point agreement management, and improve the "Internet +" medical service price and medical insurance payment policy
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The drug regulatory authorities are also formulating regulations related to "Internet + medical and health", such as the measures for the supervision and management of drug online sales
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We have reason to believe that with the blessing of medical insurance, "Internet + medical and health" will be on the fast track of development during the "14th Five-Year Plan" period
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6 The reform of DRG/DIP payment method has entered the actual payment stage.
Drugs with high clinical value, obvious patient benefits, and excellent economic evaluation will be given priority to enter the hospital drug catalog.
"Notice on the Pilot Work of the Reform of the Method", deploying the two key tasks of the pilot year, the disease diagnosis-related group (DRG) payment, the regional point method total budget, and the disease-specific value (DIP) payment, and requires 30 DRG pilot cities and 71 DIP pilot cities will enter actual payment in batches in 2021, and all pilot cities will realize actual payment by the end of 2021
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In order to promote relevant work, the National Medical Insurance Administration issued the "Management Regulations for Medical Insurance Payment by Disease Diagnosis Related Groups (DRG) (Trial)" and "Payment by Disease Points (DIP)" on April 16 and July 15 of the same year.
) Medical Security Management Regulations (for Trial Implementation)”
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On November 26 of the same year, the "Three-Year Action Plan for the Reform of DRG/DIP Payment Methods" was released.
It is planned to fully complete the reform of DRG/DIP payment methods from 2022 to 2024; Reform of payment methods; by the end of 2025, DRG/DIP payment methods will cover all eligible medical institutions that provide inpatient services, and basically achieve full coverage of diseases and medical insurance funds
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At present, on the basis of national-level pilots, almost all provinces have carried out provincial-level pilots
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The payment method of medical insurance is the main tool for medical insurance to achieve incentives and constraints on both supply and demand, and it is also a basic policy tool to supervise and regulate the behavior of medical institutions
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Inpatient service is the main expense of the traditional medical service system, so the control of inpatient cost is one of the main focuses of the medical insurance policy
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The reform of medical insurance payment methods regulates the service behavior and medical treatment behavior of both parties by establishing an incentive and restraint mechanism for both supply and demand, promotes hierarchical diagnosis and treatment, and controls medical expenses
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Disease group (disease type), weight (score) and coefficient are the three core elements of the payment method reform, and medical record management is the key to DRG/DIP grouping
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Designated medical institutions should strengthen the research on medical insurance payment rules, strengthen internal medical record management, and especially standardize the filling out of the first page of medical records, in combination with the main diseases of the hospital
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According to the payment principle of DRG and DIP, the way to make a hospital profit is simply more, faster, better, and less, that is, more patients, faster turnover, better curative effect, and lower cost
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The influence of the reform of medical insurance payment methods will gradually be transmitted from the hospital side to the drug sales side and the production side
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Drugs with high clinical value, obvious benefit to patients, and excellent economic evaluation will be given priority to enter the hospital drug catalog; drugs with low clinical value and poor economy will be phased out by the hospital
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7 Adjustment of the National Medical Insurance Drug Catalogue Medical institutions with Chinese medicine characteristics and Chinese medicine decoction pieces manufacturers should seize the development opportunity.
On December 3, 2021, the National Medical Insurance Administration, the Ministry of Human Resources and Social Security jointly issued the "National Basic Medical Insurance, Work Maternity Insurance Drug Catalog (2021)"
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In recent years, the National Medical Insurance Administration has established and improved the dynamic adjustment mechanism for the medical insurance drug catalogue.
The current catalogue adjustment cycle is once a year
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In the past three years, the variety of drug negotiation has increased significantly, and the success rate of negotiation has gradually increased
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After the drug is included in the medical insurance catalog, the market penetration rate will increase rapidly
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Pharmaceutical companies should pay attention to the adjustment trend of the National Medical Insurance Drug Catalogue and choose appropriate R&D pipelines
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According to the relevant regulations of the National Medical Insurance Administration, the provincial medical insurance departments should speed up the digestion of the original self-supplemented varieties to ensure that all digestion tasks are completed before June 30, 2022
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Recently, various provincial medical insurance departments have issued documents one after another, striving to complete the digestion and clean-up work before the specified time point
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The sales of a group of pharmaceutical companies that rely on provincial medical insurance supplements to expand their markets have been hit
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In the future, there is only one way to supplement the provincial medical insurance list, that is, according to the second paragraph of Article 6 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance", provinces (autonomous regions and municipalities) have only the authority to take the national "Basic Medical Insurance Drug List" as the basis.
, and include eligible ethnic medicines, medical institution preparations, and Chinese herbal decoction pieces into the scope of provincial medical insurance payments
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This is a policy dividend under the background of the state supporting the inheritance, innovation and development of traditional Chinese medicine
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The General Office of the State Council's "Notice on Several Policies and Measures to Accelerate the Development of Traditional Chinese Medicine Characteristics" also clarifies that Chinese herbal decoction pieces and Chinese herbal preparations prepared and used by medical institutions are subject to independent pricing
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Medical institutions and TCM decoction pieces manufacturers with characteristics of traditional Chinese medicine should seize development opportunities and strive to add in-hospital preparations and TCM decoction pieces with curative effect and cost advantages to the scope of provincial medical insurance payment
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(Author: Jiangsu Zhibang Law Firm)