National Healthcare Security Administration Response! Supporting innovative medical devices with DRG exemption!
On December 15, the National Healthcare Security Administration issued the Letter of Reply to the proposal No. 02870 (Social Management Category No. 217) of the First Meeting of the 14th National Committee of the CPPCC, which clearly stated:
We will encourage the inclusion of new technologies, new drugs and new devices in the scope of protection and stimulate the innovation and R & D motivation of pharmaceutical enterprises. In the reform of healthcare security payment methods such as DRG/DIP, full consideration should be given to the application of new technologies, new drugs and new devices. For the rational use and promotion of innovative devices, exemption from DRG (excluding payment) is an important way.
On March 4, the National Healthcare Security Administration issued the Reply to the No. 3298 Recommendation of the Fifth Session of the 13th National People’s Congress, in which the representatives proposed to further improve the Healthcare Security DRGs payment system – on new medical technology issues. The National Healthcare Security Administration gave a clear answer and further supported the exemption of innovative medical devices from “DRG”.
In the Reply, the National Healthcare Security Administration named and supported local Healthcare Security departments to explore the mechanism of establishing CHS-DRG payment to support new medical technologies in the pilot work:
For example, Beijing includes CHS-DRG payment except payment management for drugs, medical devices and diagnosis and treatment items that meet certain conditions.
Just in July last year, Beijing Healthcare Security Administratio issued the Notice on Issuing the Management Measures for Excluding Payment for CHS-DRG Paid New Drugs and Technologies (Trial), which proposed a DRG excluding payment method for the first time. It is clear that innovative drugs, innovative medical devices, and innovative medical service projects can be paid separately according to actual conditions, rather than by DRG.
The National Healthcare Security Administration has repeatedly replied that the exemption of DRG for innovative medical devices is undoubtedly a major benefit for medical device companies. The DRG payment reform has set a payment benchmark for different diseases. If the payment is lower than the standard amount, the hospital will have income. Beyond expenses, the hospital loses money. In order not to overspend at least, hospitals will inevitably carry out cost control, compress the water in treatment, and control expenses.
The DRG payment standard is based on historical medical fee data and does not take into account new technologies. Once innovative devices with higher prices are used, the total cost is difficult to control within the standard line.
After setting the payment ceiling, doctors dare not rush to use better but more expensive consumables and devices, which undoubtedly puts a straitjacket on innovative medical devices into the hospital.
Since the beginning of this year, both the central and local governments have been releasing signals to loosen the restrictions on innovative medical devices entering hospitals!
In September this year, the National Healthcare Security Administration issued the Notice on the Payment Management of Medical Consumables for Basic Healthcare Security establishing a coordinated promotion mechanism with DRG, DIP payment method reform and other policies, forming a positive superposition effect.
In addition, in terms of excluded payments, in addition to Beijing’s exemption from DRG for innovative medical devices, many regions across the country have introduced relevant policies to comprehensively promote the admission of innovative medical devices, allowing clinical doctors to “dare to use and be able to use” innovative medical devices.
For example, Foshan and Xuzhou have implemented waiver payments for very high-cost cases and special services; Sanming City has implemented an exclusion list system for some medical consumables; and Zhejiang Province has implemented a discounted reimbursement system for da Vinci surgeries.
For the rational use and promotion of innovative devices, excluding payments is one way, adjusting the total DRG budget is another.
Just this month (December 8th), the “Zhejiang Province Innovative Medical Technology Healthcare Security Payment Incentive Management Measures (Trial) (Draft for Comments)” were released. The “Trial Measures” clearly stated that for eligible innovative medical service projects (including medical materials), the total amount of DRG incentives can be increased, and Healthcare Security departments in each district and city can determine the total amount of incentives according to a certain proportion of the total DRG settlement amount this year, and steadily increase incentive efforts.
In other words, Zhejiang Province is equivalent to reserving the Healthcare Security surplus under the implementation of DRG/DIP payment reform until it is finally returned to the hospital after assessment and evaluation, and the assessment standard is the use of innovative medical devices.
In other words, to open a similar “green channel” for eligible products, so that innovative, but high price drugs and medical devices, remove the barriers to the introduction and use of hospitals.！
In addition to DRG payment reform, innovative medical devices face multiple difficulties in entering hospitals. The combination of Healthcare Security payment, commercial insurance promotion, and pricing optimization is the only way to accelerate the commercialization of innovative medical devices.
The National Healthcare Security Administration issued a reply to the No. 8013 Recommendation of the Fifth Session of the 13th National People’s Congress, pointing out that relevant policies will be improved to guide localities to timely include eligible innovative medical consumables in the scope of healthcare security payment according to procedures.
The response is the first time that the state has clarified the way to pay for innovative medical consumables, most of which have been hindered by their inability to be included in healthcare security. The response of The National Healthcare Security Administration will effectively overcome this difficulty and help the high-quality development of innovative medical consumables.
In August of this year, the Several Measures to Further Improve the Diversified Payment Mechanism and Support the Development of Innovative Pharmaceuticals and Device in Shanghai was released, which focuses on eight aspects and proposed 28 measures. It reiterates the cancellation of unreasonable restrictions on hospitals, increases support for healthcare security payments and online listing of innovative pharmaceuticals and supports the participation of innovative drugs in national drug catalog negotiations. In terms of payment method reform, innovative pharmaceuticals are given preferential treatment.
Since the establishment of the rapid approval channel for innovative medical devices by the NMPA in 2014, as of May this year, 202 innovative medical devices have been successfully approved for listing, and these innovative medical devices have ushered in major benefits with strong product advantages and policy support!
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Source: Medical Device Distributors Alliance
Translated & edited： Bradyknow
