Medical consumables supply catalog setting The "4+7" policy in the field of medical consumables has come

The National Health Commission issued the "Administrative Measures for Medical Consumables for Medical Institutions" (hereinafter referred to as the "Measures") on June 18, which not only strictly defines medical consumables, but also sets up a catalog of medical consumables for medical institutions to clarify the procurement requirements for medical consumables. And the establishment of a graded management system for the clinical use of medical consumables can be called the "4+7" policy for medical consumables. This approach will be officially implemented on September 1, 2019.

What are the key areas of the "Measures"? What is the impact on the medical consumables industry? What development trend will the medical consumables industry show in the future? Yiou Health will interpret the "Measures" from three aspects: "Medical Consumables Definition", "Supply Catalog", and "Doctor's Income".

Define "Medical Consumables"

Article 2 of the Measures stipulates: The medical consumables mentioned in these Measures refer to consumable medical devices approved by the drug regulatory authority for limited use, including disposable and reusable medical consumables.

Interpretation: Defining "medical consumables" as "consumable medical devices with a limited number of uses" directly circumvents the possibility of medical institutions classifying other medical devices with long equipment cycles as medical consumables.

Article 5 of the "Measures" stipulates that medical institutions shall designate specific departments as medical consumables management departments to be responsible for the daily management of the selection, purchase, acceptance, storage, and distribution of medical consumables; designate medical management departments to be responsible for the clinical use of medical consumables, Daily management of professional technical services such as monitoring and evaluation.

Interpretation: According to the "Measures", medical institutions will set up two departments with different functions to be responsible for the procurement, storage, and distribution of medical consumables, and the use, testing, and evaluation of medical consumables. This means that the procurement and management of medical consumables will be more professional, which will help reduce procurement costs and management expenses; at the same time, the management right and the use right will be separated, so that doctors can directly reflect the effect of medical consumables when they use medical consumables in the clinical process. The medical management department instead of the medical consumables management department will help improve the work of all departments and improve the efficiency of medical consumables.

Article 6 of the "Measures" stipulates that the personnel engaged in the management of medical consumables in medical institutions shall have professional academic qualifications, technical titles or relevant technical training suitable for the management work.

Interpretation: "There are specialties in the surgical industry", and appointing people who specialize in the management of medical consumables is conducive to reducing management costs.

Medical consumables supply catalog, new "4+7" policy

Article 7 of the "Measures" stipulates that hospitals above the second level shall establish medical consumables management committees; other medical institutions shall establish medical consumables management organizations. Village clinics (stations, stations), outpatient departments, clinics, infirmaries and other medical institutions may not have medical consumables management organizations, and the person in charge of the institution shall designate personnel to be responsible for the management of medical consumables.

Article 15 of the "Measures" stipulates that the procurement-related affairs of medical consumables shall be managed uniformly by the medical consumables management department. Other departments or departments shall not engage in the procurement of medical consumables, and shall not use medical consumables purchased and supplied by non-medical consumables management departments.

Interpretation: This means that the management of medical consumables in each hospital will achieve unified procurement and unified management. On the one hand, management costs will be reduced; on the other hand, the procurement business is directly responsible for the transfer department, which will prevent other departments from using the name of purchasing medical consumables to make gray income.

The second paragraph of Article 9 of the "Measures" stipulates that: establish a medical consumable selection system, review applications for newly purchased medical consumables, adjust medical consumables varieties or supply companies submitted by departments or departments of the institution, and formulate the institution's medical consumable supply catalog (Hereinafter referred to as the supply catalog).

Article 12 of the "Measures" stipulates that medical consumables included in the supply catalogue shall have a clear management level according to the "Medical Device Classification Catalogue" issued by the State Food and Drug Administration, which is Level I, Level II and Level III.

Article 17 of the "Measures" stipulates that the medical consumables management department shall, in accordance with the procurement application submitted by the medical consumables use department or department, in accordance with relevant laws, administrative regulations and relevant provisions of the State Council, adopt appropriate procurement methods to determine the products and supplies that need to be purchased Suppliers, purchase quantity, purchase price, etc., and sign a written purchase agreement.

Interpretation: This is the "4+7" policy in the field of medical consumables, which will break the previous business connection between hospitals and medical consumables companies. Previously, many hospitals purchased directly connected with enterprises, and a long-term cooperative relationship was formed over time, which was not conducive to the optimization of the efficiency of hospitals purchasing medical consumables. From the previous "cooperative relationship" to "consumer-producer" relationship, the "Measures" will introduce more medical consumables companies to participate in the competition, which will help reduce hospital procurement costs and other unreasonable expenses.

Article 39 of the Measures stipulates: Medical institutions shall establish a registration system for the clinical application of medical consumables to correlate medical consumables information, patient information, and diagnosis and treatment-related information to ensure that the medical consumables used can be traced forward and backward.

Interpretation: Establishing a registration system for the clinical application of medical consumables will fundamentally strengthen the strict control of medical consumables, which will prevent hospitals and doctors from using medical consumables for personal gain.

Medical consumables are "decoupled" from doctors' income

Article 56 of the "Measures" stipulates that the management of medical consumables in medical institutions shall strictly implement the relevant regulations on the management of practices in the medical and health field, so as to ensure clean purchase and use. The purchase and use of medical consumables shall not be used as the basis for the economic distribution of departments and personnel, and shall not seek improper economic benefits in the purchase and use of medical consumables.

Interpretation: Article 56 expressly stipulates that "Improper economic benefits shall not be obtained from the purchase and use of medical consumables." The staff of medical institutions shall be regulated from laws and regulations, and "gray income" shall be prohibited.

Article 57 of the "Measures" stipulates: Medical institutions shall implement relevant regulations on hospital affairs disclosure, include major medical consumables in the scope of active disclosure, and disclose relevant information such as brand product specifications, supply companies, and prices.

Interpretation: Disclosing the prices of major medical consumables and supplying companies can strengthen public supervision on the one hand, and on the other hand, it can also introduce more companies to participate in competition without forming a monopoly, which can enhance the competitiveness of medical consumables companies and help reduce hospitals purchase cost.

Article 59 of the "Measures" stipulates that medical institutions shall collect fees related to the use of medical consumables in accordance with relevant state regulations, and shall not charge fees other than those prescribed by the state for medical consumables.

 Article 60 of the Measures stipulates: Medical institutions and related personnel shall not accept funding linked to the procurement of medical consumables, and are not allowed to use medical consumables purchased without formal procurement procedures in violation of regulations.

The provisions of Article 61 of the Measures. It is strictly forbidden to conduct statistics on medical consumables related information for commercial purposes, or to facilitate statistics on medical consumables marketers.

Interpretation: The purpose of these three clauses is to prevent hospital staff from providing relevant information to medical consumables marketers, avoiding “rebates” from hospital staff and preventing hospital “corruption”.

Summary: The implementation of the "Measures" is intended to regulate various problems in the medical consumables procurement industry. Its purpose is to integrate the procurement business and transfer the procurement business to a special department to reduce management costs and reduce intermediate links. Purchasing costs: On the one hand, it improves the efficiency of the use of medical consumables, and on the other hand, it avoids the "gray space" brought by the procurement process, resulting in the phenomenon of fixed-point procurement and inefficient utilization of medical consumables. The "Measures" start from the procurement link, and reduce the cost of medical consumables. In the final analysis, it is to "relieve" and "decompress" patients. In essence, it is an important measure to benefit the people in medical reform. It is foreseeable that in the future, the price reduction trend of "medical consumables" is very obvious. However, reducing intermediate costs will not reduce the production enthusiasm of medical consumables companies. On the contrary, the "Measures" introduces more enterprise competition. For the medical consumables industry, it will usher in a new period of development.

With the further advancement of the national medical reform policy, the medical industry will once again usher in great changes. In the past, there was the "4+7" volume procurement, consistency evaluation, and DRGs pilots in the pharmaceutical industry. Later, the Ministry of Finance reviewed 77 listed medical companies, and then to the current "Administrative Measures for Medical Consumables in Medical Institutions (Trial)" Regarding the regulation of the medical consumables industry, the state's key reforms of the medical industry have been fully rolled out. The reform involves multiple related parties such as pharmaceutical companies, pharmaceutical agents, and hospitals, and covers fields such as drugs and medical consumables. The remaining medical devices closely related to the medical industry will not be far from the date of national "hands-on" reform.