Author: Guo Jinhui
It took only three months from solicitation of opinions to issuance, and only one month of preparation period from issuance to execution. The promulgation process of the "Interim Measures for the Administration of Basic Medical Insurance Medications" (hereinafter referred to as "Methods") once again reflects the country The resolute and vigorous style of the Medical Insurance Bureau.
Recently, Hu Jinglin, director of the National Medical Insurance Administration, signed the bureau’s "Order No. 1": The Interim Measures for the Administration of Basic Medical Insurance Medications have been deliberated and approved by the National Medical Insurance Administration Council and will be implemented on September 1, 2020.
The "Measures" determine the determination and adjustment of the scope of basic medical insurance medication by medical security departments at all levels, as well as the payment, management, and supervision of basic medical insurance medication.
The National Basic Medical Insurance Fund, which has a total expenditure of over 2 trillion yuan, has become the main payer of my country's health expenditure. Every adjustment of the medical insurance fund drug catalogue affects the nerves of many pharmaceutical companies. The implementation of the "Measures" will further reshape my country's pharmaceutical market.
Zhu Minglai, director of the Research Center for Health Economics and Medical Security of Nankai University, told a reporter from China Business News that the most important role of the National Medical Insurance Bureau in issuing this administrative standard with "Order No. 1" is to build a template for open and transparent management. The Measures will play a very good leading role in future work in this area. In the future, pharmaceutical companies will no longer need to blindly inquire about news as they did in the past when adjusting the catalog. It is enough to follow the procedures stipulated in the Measures.
Eight types of "magic drugs" are out
On April 29, the National Medical Insurance Administration issued the "Interim Measures for the Administration of Basic Medical Insurance Medications (Draft for Solicitation of Comments)"; late at night on July 31, the revised and reviewed "Measures" were published in a low-key manner on the bureau's website.
The "Measures" only took three months from soliciting opinions to issuance, and from issuance to implementation, it only left a one-month preparation period. These procedures all reflect the resolute and vigorous style of the National Medical Insurance Administration as always.
The core of the "Measures", that is, the part that has received the most attention from the market, is the formulation and adjustment of Chapter 2 "Basic Medical Insurance Drug List" (hereinafter referred to as "Drug List"). The "Measures" divide drugs into two categories: "included" and "not included and transferred." The requirements for including drugs are approved by the national drug regulatory authority and meet the basic conditions of clinical necessity, safety and effectiveness, and reasonable prices.
Under the category of "not included and transferred", it is divided into three categories according to the different nature of drugs-not included, transferred directly, and can be transferred.
"Miracle medicines" such as health care products that have attracted public attention are clearly listed as not included in the "Drug List", including medicines that mainly play a nourishing role; medicines containing national precious and endangered wild animals and plants; health care medicines; mainly for enhancement Drugs for sexual function, treatment of hair loss, weight loss, beauty, smoking cessation, alcohol cessation, etc.; alcohol preparations, tea preparations, various fruity preparations (except for children's medicines under special circumstances), oral medicaments and oral effervescents ( Except for special regulations) and other eight categories.
The above-mentioned eight types of drugs are all drugs with unclear clinical efficacy or non-therapeutic drugs. Therefore, under the current medical insurance adjustment rules, they cannot reach the pharmacoeconomic verification and it is difficult to pass the current medical insurance payment standards.
Xu Yu, a medical reform expert and deputy director of the Health Bureau of Shanyang County, Shaanxi Province, told a reporter from China Business News that the Measures have deleted Class B OTC drugs, broken decoction pieces, and refined decoction pieces compared with the draft for comments. The reprocessed decoction pieces show that the Medical Insurance Bureau attaches importance to and responds to relevant opinions raised by pharmaceutical companies and pharmacies.
The supplement to the "Measures" supplements OTC drugs and proposes that in principle, OTC drugs will no longer be added to the "Drug List". "No more new additions means that pharmaceutical companies can get rid of unreasonable thinking." Xu Yucai said.
Xu Yucai said that the "Measures" also reflect that future expert review will play an important role in the adjustment of the medical insurance catalog. For example, Article 9 states that in some cases, after expert review, drugs are directly transferred out of the "Drug List". The third paragraph of the experts can play an important role. The specific content is "comprehensive consideration of clinical value, adverse reactions, and drug economics." Factors such as sex, after evaluation, the risk is greater than the benefit of the drug".
Another highlight of the "Measures" is to propose that the medical security administrative department of the State Council establish and improve a dynamic adjustment mechanism, which in principle is adjusted once a year. The medical security administrative department of the State Council determines the scope and specific conditions of the adjustment of the "Drug Catalog" that year according to the needs of medical insurance and drug security, the income and expenditure of the basic medical insurance fund, the affordability, and the focus of catalog management, research and formulation of adjustment work plans, and solicit The opinions of relevant departments and parties shall be announced to the public.
Zhu Minglai stated that this time the "Measures" clearly stipulated the administrative jurisdiction of the medical insurance department, and proposed that the medical insurance administrative department of the State Council is responsible for establishing a basic medical insurance medication management system, formulating and adjusting the scope of basic medical insurance medications across the country, using and paying in principle. Although these contents are stipulated in the State Council’s institutional reform plan, as a government department, the administrative jurisdiction and content of the jurisdiction of the National Medical Insurance Bureau should still be based on administrative regulations.
Pharmaceutical companies no longer "blind people touch the elephant"
Zhu Minglai said that since the adjustment of the drug catalog in 2016, China has experienced several major events, such as targeted drug negotiations, "4+7 volume procurement", etc. Although there are clearer documents for each recruitment, However, due to the lack of standardized administrative regulations, every time a bid is launched, pharmaceutical companies are always in the dark, so they are accustomed to inquiring about news everywhere and understanding the procedures of government departments like blind people.
The open secret of the industry is that in order to enter the medical insurance catalogue, pharmaceutical companies often did some work that could not be put on the table, such as finding relevant pharmaceutical economists to do "public relations" work, which can actually play a very limited role. Because every expert has signed a strict confidentiality mechanism with the government department.
Professor Hu Shanlian of Fudan University once issued a paper on the 2019 medical insurance catalogue negotiations. In the 2019 National Medical Insurance Drug Catalogue negotiation access work, the National Medical Security Administration organized a "pharmacoeconomics measurement expert group", and all experts stated that they abide by the "measurement expert" Code", signed the "Confidentiality and Integrity Commitment" and "No Conflict of Interest Statement", adhere to the strict principle of avoidance of interests and randomness, establish and improve the internal control mechanism, and strictly manage confidentiality.
Zhu Minglai said that the promulgation of the "Measures" will make the adjustment of the medical insurance catalog more open and transparent, and pharmaceutical companies will also have a better mind. There is no need to make those futile "efforts", as long as they are done in accordance with the requirements of the government. .
The "Measures" also spent a lot of space stipulating the link between the access to the drug catalogue and the medical insurance payment standards. For example, Article 12 points out that, in addition to Chinese herbal medicines, in principle, new drugs included in the "Drug Catalog" shall simultaneously determine payment standards. Exclusive drugs determine the payment standard through access negotiation. Among the non-exclusive drugs, the national organization of drugs selected for centralized drug procurement (hereinafter referred to as "centralized procurement") shall determine the payment standard in accordance with the relevant provisions of centralized procurement; other non-exclusive drugs shall determine the payment standard based on access bidding and other methods.
Zhu Minglai said that such regulations have been used in medical insurance negotiations in recent years, but this is the first time that they have been fixed in the form of words and regulations. They are a very good scientific and standardized management method. Pharmaceutical companies are also very concerned about these contents, especially the payment standards after acceptance during the negotiation period. Especially for foreign-funded pharmaceutical companies, they are not afraid of strict rules, but hope that "the ugly words can be said to the front" so that companies can pursue the maximization of commercial interests within the limits of the rules.
Article 18 of the "Measures" states that, in principle, the negotiated drug agreement is valid for two years. During the agreement period, the medical insurance department can adjust the payment standard for the drug according to the price level of the generic drug, or it can include the generic name in the scope of centralized procurement. After the expiration of the agreement, if the negotiated drug is still exclusive, the payment standard shall be adjusted according to relevant rules and the agreement shall be renewed.