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[MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement

작성자 MDREX 날짜 2024-06-27 17:52:53 조회수 16

 

MDREX Newsletter

2024.6.27.

MDREX, Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective Reimbursement/Non-Reimbursement

 

The "Innovative Medical Technology System," introduced in July 2018 as part of the "Medical Device Regulatory Innovation and Industry Promotion Plan," allows for exceptional temporary insurance registration (applying non-reimbursement or selective reimbursement costs) for medical technologies with high potential value. These are technologies that, due to a lack of evidence, were designated as research-stage during the existing new medical technology assessment process but are considered future promising technologies (such as AI and robotics). This system permits "evidence generation" (collecting clinical trial data over 3-5 years). As of now, a total of 24 medical technologies have been designated as innovative medical technologies, with over 16 of these incorporating artificial intelligence (AI) technology.

 

In December 2023, the Ministry of Health and Welfare and the Health Insurance Review and Assessment (hereafter referred to as HIRA) announced the "Guidelines for the Temporary Insurance Registration of Innovative Medical Technologies (Digital Therapeutics and Artificial Intelligence)." These guidelines specify the selective reimbursement (90% patient co-payment) or non-reimbursement maximum amount criteria for the temporary insurance registration of innovative medical technologies incorporating artificial intelligence (AI) technology, as detailed in the table below.

 

Grade

Classification

Selective Reimbursement (KRW)

Non-Reimbursable

(KRW)

1

Pathological Examination

2,920

29,200 ~ 87,600

2

Special Imaging Diagnosis

(MRI, CT, PET etc.)

1,810

18,100 ~ 54,300

3

Endoscopy, Ultrasound

1,180

11,800 ~ 35,400

4

Other

310

3,100 ~ 9,300

 

Under the National Health Insurance Act, non-reimbursable are generally not subject to government cost determination. However, for temporary insurance registration, the government has announced non-reimbursable upper limits in a pilot project format in accordance with the National Health Care Act.

 

Based on the table, the following innovative medical technologies are currently designated for temporary insurance registration for two products, while the evaluation process for temporary insurance registration is ongoing for the remaining products. Until a decision on temporary insurance registration is made, these products can be used as non-reimbursable with no predetermined upper limit.

 

No.

Innovative Medical Technology Name

Classification

Selective Reimbursement/ Non-Reimbursable

Temporary Registration Amount (KRW)

1

Artificial Intelligence-based Ischemic Stroke Detection using MR image

Grade 2

Non-Reimbursable

18,100

2

Artificial Intelligence-based screening test for left ventricular systolic dysfunction using 12-lead electrocardiogram data

Grade 4

Non-Reimbursable

9,300

 

If your company's product falls under evaluation as a new medical technology utilizing artificial

intelligence, it would be worthwhile to consider utilizing the Innovative Medical Technology System

when entering the Korean market. If you have any questions regarding the above information, please

feel free to contact us at MDREX (pro@mdrex.co.kr) anytime. Please note that for specific administrative procedures regarding the Korean regulation, you can find detailed information on the MDREX YouTube Channel at https://www.youtube.com/@RA_QA_MA.

 

 

Thank you

From MDREX

MDREX is a boutique Korea Medical Device Regulatory, Quality, Compliance, Reimbursement and Clinical Consulting Firm dedicated to providing strategic and operational consulting service to medical device and digital health companies worldwide.