• 2020-04-28

A few days ago, the List of Matters Concerning Administrative Law Enforcement (2020 Edition) (hereinafter to the List) was released by the National Healthcare Security Administration (NHSA). According to the Article 6 of the List, supervision and inspection will be conducted for the compliance of the centralized procurement of high-value medical consumables in public medical institutions.

It is said that the inspection mainly focus on the bills and data of each medical institution. As noted in the List (2020 Edition), during the supervision and inspection on price, the parties concerned or relevant personnel will be questioned and required to provide supporting evidence and other materials related to price violations (if any); meanwhile, inquiry and copying of accounting books, bills, vouchers, documents and other information related to price violations (if any) will be performed, and bank information related to price violations (if any) will be checked.

Under the national governance framework for consumables, each province shall roll out rules of consumables usage. The emphasis of supervision is the amount of consumables usage. The higher the usage amount of a certain type of consumables, the higher the reimbursement ratio in the medical insurance. Any value higher than the normal level will be deemed as abnormalities. It can be seen that procurement of medical consumables or those with high settlement price will be the priority of the inspection.

Notably, circulation link of medical device enterprises is also one of the focuses. On April 14, the National Medical Products Administration (NMPA) issued the Notice of Department of Comprehensive Affairs, Planning, and Finance Affairs under NMPA on Strengthening the Supervision and Inspection of Sterile and Implantable Medical Devices, which clearly stated that supervision and inspection shall be conducted on key medical device enterprises, critical varieties and important links. During the circulation links, inspection shall be focused on the following enterprises: a) Enterprises which have been disqualified in spot check of multiple batches in the same year, same variety for many years, and various varieties for many years; b) Enterprises with serious defects or inadequate rectification in previous supervision and inspection or unannounced inspection; c) Enterprises with inadequate training or incomplete self-inspection and enterprises that fail to submit self-inspection reports on time or whose self-examination reports are not informative; d) Other enterprises that may have significant safety risks which require close attention.