October 30, 2024

The pre-entry program for health technologies allows certain novel treatment methods to be temporarily exempt from the standard new health technology assessment process prescribed in Article 53 of the Medical Service Act. This program includes deferred assessment technologies, innovative health technologies, and limited health technologies (those urgently needed in the market due to the lack of alternatives).

On October 29, 2024, the MOHW made a press release and announced a

legislative notice for the amendment (draft) to the Rules on New Health Technology Assessment (MOHW Ordinance), which includes the following changes with regards to the pre-entry program of health technologies:

Healthcare providers must obtain from patients and other subjects written consent concerning the pre-entry program after providing a thorough explanation of the purpose of use, procedural methods, treatment costs, and potential adverse events/side effects, etc.

Mandatory reporting of usage of pre-entry health technologies during the permitted duration designated by official notification.

For health technologies designated as deferred assessment technology, providers may request for a one-time, two-year extension 30 days prior to the expiration of the initial two-year period.

The scope now includes in-vitro diagnostics, genetic tests, and non-invasive diagnostics and health technologies.

These revisions to the provisions will also apply retroactively to existing health technologies already designated as pre-entry health technologies.

Cost-related matters are governed by the National Health Insurance Act and therefore are not affected by this amendment to the Rules on New Health Technology Assessment under the Medical Service Act. Accordingly, deferred assessment technologies will continue to be available as "non-reimbursables", while innovative health technologies can be used with predetermined maximum prices as either "non-reimbursables" or "selectively reimbursed".

2. Announcement of New HIRA Review Guidelines

To prevent indiscriminate use of medical procedures/materials and abuse of medical care benefit claims, the MOHW announced a detailed criteria for medical care benefit eligibility, including scope, limits, etc., in accordance with Article 41 of the National Health Insurance Act (“Detailed Eligibility Criteria and Methods for Medical Care Benefits”). Simultaneously, HIRA published a "Review Guidelines" to clarify ambiguous matters during the review process of medical care benefit claims, in accordance with Article 4 of the Standards for Processing Medical Care Benefit Claim Review and Payment.  

HIRA has announced that these newly established review guidelines primarily aim to clarify previously ambiguous criteria regarding eligible indications, etc. covered under medical care benefits. However, as these clarifications may restrict the scope of patients and products currently covered under the national insurance, we recommend that companies review their products' coverage status under the new guidelines as summarized below:

▶ Refined criteria for "conservative treatment period" in the coverage for Artificial Disc Replacement (ADR) surgery.

▶ Clarification of "early surgery approval criteria" in the reimbursement standards for endoscopic discectomy.

▶ Clarification of eligible products in the detailed reimbursement criteria for endoscopic automatic suturing devices.

▶ Clarification of patient eligibility and other criteria in the reimbursement standards for Cone Beam Computed Tomography (CBCT) of the temporal bone.

▶ Others

Please consider these updates when developing your medical device reimbursement strategies. As a specialized consulting firm in the medical device field, MDREX promptly identifies domestic medical device regulations and supports manufacturers and importers in regulatory compliance.

For assistance with medical device regulations and market entry,

please contact MDREX at pro@mdrex.co.kr