Sang-Soo Lee, PhD, MBA, Sr. Director, Government Affairs and Market Access (GAMA), Medtronic Korea, Seoul, South Korea and Head of Center of Expertise (COE), GAMA, Medtronic Asia Pacific
1. Determination of national health insurance coverage for digital therapeutics (DTx) and artificial intelligence-enabled innovative medical technology
On October 26, 2023, the Ministry of Health and Welfare (MoHW) announced that it has prepared specific national health insurance (NHI) coverage plans for digital therapeutics (DTx) and artificial intelligence (AI)-enabled imaging diagnostic medical devices, which are new medical technology fields.[1] In accordance with the NHI guidelines for these technologies, prepared last August, AI-enabled technologies among innovative medical technology (with a 90% patient copayment rate under the Selective Benefit program) are subject to a separate fee ranging from 310 to 2,920 Korean won, while the fee for using DTx is determined based on the cost of each product.
Considering that AI-enabled technology serves as a diagnostic aid or a technology used in clinical settings, reimbursement payment is provided for each product at a rate of 10% when an imaging specialist interprets the data. This payment is made as an add-on, taking into account the testing time and frequency required in each clinical field. An additional extra charge is applied if the potential value is evaluated to be high during the review and evaluation process of innovative medical devices. Additionally, in cases where non-coverage is applicable, the MoHW plans to set an upper limit for each field to prevent an excessive patient burden. The upper limit for each field will be determined as a group, at a rate of 10% to 30% of the cost of imaging tests to which AI-enabled technology is applied.
Exchange rate: 1 USD = 1,350 Korean won
| Fee for imaging testing and artificial intelligence-enabled technology (draft) |
| Group | Field | Relative value unit (RVU) on average (point) | Payment amount* (Korean won)/USD |
| Group 1 | Pathological examination | 36.68 | 2,920/2.16 |
| Group 2 | Special imaging diagnosis (MRI, CT, PET, etc.) | 22.77 | 1,810/1.34 |
| Group 3 | Endoscopy and ultrasound | 14.80 | 1,180/0.87 |
| Group 4 | Others | 3.92 | 310/0.23 |
| * If a significant improvement in accuracy or a reduction in errors compared to conventional technology is recognized, an addition of 10~20% of the relevant amount will be applied. |
In order to effectively manage the use of DTx, especially for mental and chronic diseases, a new fee for clinicians will be introduced. This fee, covering explanations, education, and evaluations conducted on an outpatient basis, will remain the same regardless of the type of medical device, whether it is covered or not. It is designed as a reimbursement to encourage active monitoring during the early stages of implementation and to alleviate the financial burden on patients. Fee for DTX (draft) |
| Category | Payment amount
(Korean won/USD) | Remark |
| Prescription fee for DTx | 5,230/3.87 | Training for device activation and initial use upon first prescription |
| Effectiveness evaluation fee for DTx | 16,130/11.95 | Comprehensive payment for usability confirmation and treatment evaluation after device use and plan operation |
2. Publication of National Health Insurance Reimbursement Guidelines for Digital Therapeutics and artificial intelligence (AI)-Embedded Technologies
On August 25, 2023, the Health Insurance Review and Assessment Service (HIRA) published new national health insurance reimbursement guidelines for digital therapeutics (DTx) and revised guideline for artificial intelligence (AI)-embedded technologies[2],[3],[4]. The newly established and revised guidelines support the creation of evidence through the accelerated use of innovative medical technologies in the clinical field, as announced through an integrated review and evaluation of innovative medical devices. These guidelines were prepared after collecting various opinions from related specialty societies and associations, experts, civic groups, and industries, and more.
The guidelines encompass the following key components: 1) national health insurance reimbursement process for innovative medical technologies, 2) application process and method for temporary coverage code decision, 3) non-coverage management, and 4) follow-up management including monitoring. Moreover, HIRA has outlined plans to release a comprehensive operating guideline in the future. This subsequent guideline will delve into intricate aspects including criteria for pricing temporary coverage of innovative medical technologies and methods for submitting claims. HIRA remains committed to enhancing the guidelines through ongoing and open communication with stakeholders. HIRA seeks to optimize the utilization and evaluation of these technologies within the national health insurance system.
The “Integrated Review and Evaluation System of Innovative Medical Devices”, which came into effect in October 2022, is designed to streamline the timeline for introducing innovative medical devices into the healthcare domain. This system concurrently reviews the designation of innovative medical devices, regulatory approvals, determination of NHI coverage eligibility, and evaluation of innovative health technology. Simultaneously, the pertinent ministries and agencies are engaged in expanding the recognition of innovation and simplifying the assessment of innovative health technology.
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