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The First Time in the Country! The Medical Insurance Bureau Orders: A large Number of Medical Devices Exempted from the DRG

2022-07-20

On 13 July, the Beijing Municipal Medical Insurance Bureau issued the Notice on the Issuance of the Management of Excluded Payments for New Drugs and Technologies for CHS-DRG Payments (Trial) (Hereinafter referred to as the Notice).

The notice proposes a DRG exclusion payment method, specifying that innovative drugs, innovative medical devices and innovative medical service items can be paid separately on an actual basis without being paid under the DRG method.
DRG payment reform, is in recent years, in addition to the Volume purchase, national medical insurance negotiations, another core means of medical insurance cost control, this policy for the first time proposes innovative devices, drugs, etc. can be exempt from cost control means, will undoubtedly greatly encourage the enthusiasm of the pharmaceutical industry innovation.
DRG exemption for innovative devices starts to be paid separately!
 According to the notification, innovative drugs/innovative medical devices that meet the requirements need to satisfy two main points of innovation.
1.    New generic drugs/medical devices that have been approved by the drug regulatory authorities for marketing within three years (including the year of declaration and the two natural years prior to it); new medical devices that can be charged separately due to price adjustment within three years.
2.The clinical effect is greatly improved compared with traditional drugs/medical devices.
   At the same time, for the declaration of innovative drugs/medical devices, the cumulative number of cases of basic medical insurance participants in the city needs to reach at least 50 cases, while rare diseases are not limited in the number of cases.
   If the product is confirmed to be eligible, it can be declared by the company to the Beijing Medical Insurance Affairs Management Centre.
CHS-DRG Application Form for Excluded Medical Devices on a Fee Basis.
Name of the firm(sealed)                        Date of filling the form :
Name of the medical device
Medical device Registration Certificate Number
Time to market
National medical insurance code (27 digits)
Major diagnostic categories of affiliation
(MDC)
Medical device charges
Expected sales
First year:     (yuan)   Second year:                     (yuan)
It must be used in conjunction with diagnosis and treatment items  Yes ¨      No.¨
Name of the diagnosis and treatment items
National medical insurance code
Medical insurance code of the city
Medical Insurance Category
Designated medical institutions have been established in Beijing
HIS code of medical device
1.
2.
3.
4
5
Specific description
1.     Scope of application
2. Usage method
3. Clinical effect
4. Innovation or superiority (Including but not limited to the comparison of advantages and disadvantages of traditional devices, including but not limited to comparison materials with alternative drugs, medical devices and related literature materials (Chinese electronic version))
5. Other
Signature of enterprise legal person:           Filler:               Contact information:
The policy is liberalized! Good for all manufacturers and distributors
For enterprises, the liberalization of this policy, on the one hand, is conducive to directly allowing innovative medical devices to obtain more reasonable benefits; at the same time, it further reflects the purpose of “encouraging innovation” of China’s medical insurance (In the past, it was more to control costs)。
According to the NMPA, more than 383 products have entered the green channel of innovative medical devices, and 166 products with strong innovation, high technical content and significant clinical value have been launched. In the first half of 2022 alone, 65 products from 55 companies entered the special approval channel for innovative medical devices, of which 36 products entered the national innovation approval channel and 29 products entered the provincial innovation approval channel.
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Source:Medical Device Dealer Alliance
Edited & translated by:Bradyknows