Expert Interpretation: From "Blacklist" to "Whitelist": China's Medical Consumables Enter a New Stage of Access Management

【Summary】On June 8, 2020, China's National Healthcare Security Administration issued the "Draft Interim Measures for the Management of Medical Consumables under the Basic Medical Insurance System" (hereinafter referred to as the "Draft Interim Measures") for public comment.

                                                                

Source: China Medical Insurance

Author: Libo Tao, Peking University Medical Department

On June 8, 2020, China's National Healthcare Security Administration issued the "Draft Interim Measures for the Management of Medical Consumables under the Basic Medical Insurance System" (hereinafter referred to as the "Draft Interim Measures") for public comment.

Those familiar with this field know that the management of medical consumables under China's medical insurance system has long lacked overall regulation. Therefore, the formulation and future implementation of this draft has the significance of a "milestone" in this field and will have a profound impact on related industries.

                                                                                              

Looking at this newly released draft of the "Interim Measures," there are many highlights, and one of the most striking is the introduction of "access management" in the field of medical consumables Article 3 of Chapter 1 clearly states: "[Access Management] The State Council's medical security administrative department, taking into account factors such as the function, clinical value, cost level, and affordability of medical consumables for medical insurance funds, will use access management to formulate the "Catalog of Medical Consumables under the Basic Medical Insurance System" (hereinafter referred to as the "Catalog") and update it regularly and dynamically. Medical consumables in the "Catalog" will be included in the medical insurance fund payment scope as stipulated."

 

In the field of medical consumables in China, the previous management method of the national medical insurance system was, in principle, "non-prohibition means inclusion" that is, unless the medical insurance department explicitly stipulates that certain medical consumables are not included in reimbursement, or that the pricing and use of certain consumables (mainly high-value consumables) must meet the special requirements of medical insurance, most medical consumables can be directly included in the medical insurance scope and can be charged and reimbursed separately or as part of medical service items. This is what people jokingly call the "blacklist" method.

 

With the continuous deepening of China's medical reforms and the strengthening of pharmaceutical reforms, drug costs have been controlled to a certain extent, and especially with the strict monitoring of the "drug ratio," the use and amount of medical consumables have experienced compensatory rapid growth, consuming part of the achievements of pharmaceutical reforms. Therefore, some departments and regions have also proposed the management approach of monitoring the "consumable ratio" in an attempt to control the disorder in the medical consumables field.

 

In fact, using rigid indicators such as drug ratio and consumable ratio to forcibly assess and constrain the complex and changeable medical behaviors has always been criticized. To straighten out the use and payment of medical consumables, a more complete management strategy is needed. In this draft of the "Interim Measures," we see that the medical insurance department, referring to the reform experience of drug access management, comprehensively proposes a consumable access management method, reflecting such a change in management thinking.

                                                                                                                   

China's medical insurance system has long accumulated experience in drug access management. The core of access management is catalog management; only those included in the catalog can be used and paid for within the scope of medical insurance, which is the so-called "whitelist" system. To be able to enter and remain in the catalog, one must abide by a series of regulations of medical insurance in terms of pricing, procurement, use, and reimbursement, thus forming a clearly defined management standard. The drug management in this aspect already has a complete system construction.

 

In this draft of the "Interim Measures," the catalog management of medical consumables is comprehensively standardized, which is in fact the main content of this document, including "Chapter 2: Determination of the Catalog of Medical Consumables under the Basic Medical Insurance System," "Chapter 3: Use of the Catalog of Medical Consumables under the Basic Medical Insurance System," and "Chapter 4: Medical Insurance Payment for Medical Consumables," forming a complete system.

 

In the determination mechanism of the consumable catalog, the draft of the "Interim Measures" clarifies inclusion, non-inclusion, and removal These three parts. This clearly draws lessons from the long-standing experience of drug catalog management of "only inclusion, no removal." At the same time, this section also clarifies the expert review mechanism and access coding mechanism in the formulation and adjustment of the catalog.

 

The consumable coding mechanism is particularly noteworthy here. Compared with drugs that can be managed based on generic names, the classification and coding management of the vast variety of medical consumables is very difficult. However, thanks to arduous efforts, China's National Healthcare Security Administration has already formulated its own consumable coding system. Therefore, it is clearly stipulated here that: "Newly listed medical consumables will first be coded according to the medical insurance medical consumable coding rules. If the coding of the medical consumable is consistent with the coding of the medical consumables in the catalog, it will automatically belong to the medical insurance fund payment scope, and the payment policies and rules will be consistent with those of the medical consumables with the same coding in the catalog."

 

However, due to the complexity and diversity of medical consumables, a loophole is left for handling specific issues specifically: "If the coding of the medical consumable is inconsistent with the coding of the medical consumables in the catalog, the State Council's medical security administrative department will organize expert review in a timely manner to determine whether to include it in the Catalog." It is expected that there will be complex games in this aspect, requiring more detailed regulations.

 

In the use mechanism of the consumable catalog, the draft of the "Interim Measures" clarifies that consumables used in public hospitals must undergo centralized procurement, and negotiated consumables can be directly purchased online. Medical institutions are required to prioritize the use of centrally procured products, thus linking up with the volume-based procurement of medical consumables.

 

At the same time, the update method of consumable coding is also emphasized in the catalog use mechanism. As mentioned earlier, the classification and coding system of consumables is the focus of medical insurance consumable management.

                                                                                                            

In the payment mechanism for consumables, the draft of the "Interim Measures" clarifies the situations of payment and non-payment, emphasizing the non-payment for unreasonable consumable use phenomena such as "exceeding the reasonable scope of use" and "exceeding the actual implanted quantity of implantable consumables," which is worthy of attention by medical institutions and consumable manufacturers.

 

At the same time, the medical insurance payment standard for consumables is clearly defined here. "For exclusive products, the initial medical insurance payment standard will be determined through negotiation, in principle; for non-exclusive products, the payment standard will be determined and adjusted through centralized procurement, in principle." On the premise that the specific payment standard for consumables is determined by the national medical insurance department, the specific payment methods and payment ratios will be determined by local medical insurance departments, reflecting flexibility in management.

 

Finally, the consumable payment method section also points out: "Support local areas to include medical consumables in the catalog into bundled payment methods such as per-disease type and per-disease diagnosis-related group (DRG) payment" This leaves an interface for linking with payment method reforms such as DRGs, but the specific regulations in this aspect need further clarification.

 

In addition, other parts of the draft of the "Interim Measures" also standardize other related contents of consumable access management, such as supervision work, forming a complete management standard.

 

In short, in this draft of the "Interim Measures for Management", China's medical insurance management of medical consumables will move towards a "whitelist" style of access management. If the final official policy is implemented, this will be a major change in China's medical consumables management, and will have a profound impact on related fields. Looking at the relevant content in the document, the principles and methods of consumable access management are mainly derived from related practices in the pharmaceutical field. While leveraging prior experience is beneficial, it's crucial to acknowledge the significant differences between medical consumables and pharmaceuticals. Therefore, the access management of medical consumables requires meticulous institutional arrangements to achieve good reform results. Further in-depth work in this area is expected in the future.

 

Source: China Medical Insurance