What happens when the UDI of the Thousand Ends and the Collection of Destroying Decay collide together?
UDI covers a large number of collection varieties and reports into the countdown
A few days ago, the Guangdong Provincial Medical Insurance Bureau and the Food and Drug Administration issued the "Notice on Carrying out the Maintenance of The National Medical Insurance Consumables Standard Code and the Unique Identification Data Information of Medical Devices" (hereinafter referred to as the "Notice"), requiring the maintenance of the national medical insurance consumables standard code and UDI data.
UDI is the unique identification of medical devices, equivalent to the product IDENTITY card, it can be bound with all management requirements, binding is the control relationship, no matter which coding system it is in, its ID card is the same.
The "Notice" clarifies that the product scope of the medical insurance consumables code and UDI code maintenance is: artificial joints, new crown consumables reagents and supporting sampling equipment, new crown vaccine syringes, disposable intravenous blood collection needles and other nine types of low-value medical consumables, oral implants, orthopedic trauma consumables, stents, ultrasonic knife heads, coronary balloons, intraocular lenses, drug balloons, pre-filled catheter cleaners and other types of consumables
Scope of maintenance enterprises: the above-mentioned medical consumables and reagent manufacturers that have obtained registration or filing with the drug regulatory authorities and intend to sell them in various medical institutions in Guangdong Province.
The enterprise logs on to the national "medical insurance medical consumables classification and code database dynamic maintenance" system to maintain the national medical insurance consumables standard code and medical insurance consumables flow code corresponding to the medical consumables products of the enterprise. The enterprise logs on to the "Medical Device Unique Identification Database" of the State Drug Administration to maintain the UDI data code of the corresponding medical consumables products of the enterprise.
In terms of time requirements, the artificial joints that have been collected by the state have not yet maintained the medical insurance consumables code and UDI code, please complete it before April 30, 2022. The upcoming inter-provincial alliance procurement of COVID-19 testing reagents and 8 types of consumable reagents such as supporting consumables, sampling devices, and COVID-19 vaccine syringes in Guangdong Province should be completed before May 20, 2022.
The "Notice" emphasizes that according to the provisions of Medical Insurance Fa [2022] No. 1, the products collected by the state or province need to be "bidding with codes, procurement with codes, and settlements with codes" according to medical insurance codes and UDI codes, and products that have not yet been coded can be carried out by each procurement platform after the enterprise maintains the relevant product information and obtains the medical insurance code and UDI code, and each procurement platform can carry out centralized procurement, supply and distribution of operating enterprises, procurement and use of medical institutions and settlement. Enterprises are responsible for maintaining the authenticity and accuracy of information, and actively promote data sharing on information platforms such as registration, production, circulation, use, and settlement of medical consumables.
Instrument garbled, has a long history?
The unique identification database of medical devices has been officially launched for more than two years, and UDI has gradually become the "electronic identity card" of medical devices. However, the diversity and complexity of medical device products are extremely high, and it is a systematic project to achieve one device, one code and one identity.
An authoritative person in the industry once told Cyberblue Devices that in fact, UDI is like an ID card, and other HCBS and medical insurance codes are like a bunch of bank card numbers, they are all connected together by UDI, so when designing UDI codes, they must also correspond to other codes.
Lin Xin, a professional responsible for the construction of medical insurance data in many places, analyzed the Cyberblue devices, the previous coding environment was very chaotic, there were nearly ten different consumables coding standards in the country, some provinces could be unified, but some were not the same in use, and some enterprises and cities would build a set of flow codes by themselves, and the whole was confused with each other.
"In the past, there were many drawbacks, such as the internal traceability of medical institutions, but if the system of medical institutions is difficult to interconnect, some in the category can achieve the traceability of the whole process, but some low-value consumables products can not be achieved because of the relatively large amount."
She said that the amount of low-quality consumables used and consumed is very large, and the cost and difficulty of coding and management are also very large, because the amount is too much.
"This is a very complex and long-term work, many countries are also carrying out related barrier work, so our difficulty is still relatively large, we need all enterprises to cooperate together, but this work has been carried out for a long time, 2019 has been, now need to make it richer, more landed."
UDI hitched a ride on the collection car, what are the odds of winning?
Compared with the scope of UDI implementation varieties previously released by the state and local governments, this document in Guangdong Province has a distinct collection color. Can UDI and collection resonance speed up the coverage process?
Lin Xin believes that the policy of Guangdong Province should be to link medical insurance and enterprises, in fact, behind it is to open up the payment system and the production and sales system, which is very meaningful. Once opened, the varieties that are now collected and the varieties that will be collected in the future will be carried out on this platform, and the main body is manufacturers, some branches, distributors, hospitals, medical insurance systems, drug supervision systems, etc.
"Some are suitable for procurement, some are suitable for bidding with medical institutions, and some are suitable for payment to dealers, but all this must be unified, which is this one code, which can meet both bidding and procurement, and can also meet payment, supervision, statistics, analysis, etc."
The role of medical insurance in this is to catalog and standardize these, and the online declaration, publicity and inquiry under the integration of recruitment and procurement can achieve one-code interoperability, which is also more conducive to some payment appeals and expert arguments, and is more and more complete. In this way, the data will be connected, and the monitoring of the entire medical system will be better.
In addition, guangdong province's management of low-value consumables is very prominent, she said: "Now there are more low-value consumables, coding information is also chaotic, like disposable infusion devices have large packaging and small packaging, some only print codes on the packaging, and some have codes on each small package." ”
This management method may involve logistics, cold chain and other information in the future, if it can be moved in, it is a very good supervision system, and the enterprise is also very convenient.
However, UDI encoding and collection coding are two different functions, and their joint applications need to be treated differently.
Yang Jianlong, director of the China Medical Equipment Association, told Cyberblue Devices that according to the relevant design of drug supervision and medical insurance, UDI is to cover all products, requiring "one thing and one code", but the collection of consumables is according to the category.
"For example, an artificial knee joint collection, it is divided into many models, and divided into different materials, places of origin, manufacturers, batches, etc., but it is impossible to reflect the batch when collecting, no matter which batch can not reflect the manufacturer and date, at this time they are not necessarily one-to-one correspondence." But both medicare and hospitals want each device to have a UDI code, which should be possible. It can be said that the document in Guangdong this time is a coded map, which is convenient for tracking and management. ”
It can be seen that whether it is collection or conventional procurement, the electronic supervision of medical devices has long been not an imaginary period, and the mode of mutual knowledge, mutual seeing and mutual connection is breaking more regulatory islands.