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Enforcement Decree of the National Health Insurance Act

국민건강보험법 시행령

Article 18-2 (Criteria for Reduction of Upper Limit Amount of Medical Care Benefit Costs for Drugs and Suspension of Application of Medical Care Benefits, etc.)

제18조의2 약제에 대한 요양급여비용 상한금액의 감액 및 요양급여의 적용 정지 기준 등

Ministry
보건복지부
In force
2026-02-19
Articles
123
Original (Korean)

보건복지부장관은 법 제41조의2에 따라 약제에 대한 요양급여비용의 상한금액(법 제41조제3항에 따라 약제별 요양급여비용의 상한으로 정한 금액을 말한다. 이하 "상한금액"이라 한다)을 감액하거나 요양급여의 적용을 정지한 경우에는 그 사실을 공단과 심사평가원에 통보하여 상한금액 감액 및 요양급여의 적용 정지 내역을 기록ㆍ관리하도록 하여야 한다.

The Minister of Health and Welfare shall, upon reducing the upper limit amount of medical care benefit costs for drugs (meaning the amount determined as the upper limit of medical care benefit costs for each drug pursuant to Article 41 (3) of the Act. Hereinafter referred to as the "upper limit amount") or suspending the application of medical care benefits pursuant to Article 41-2 of the Act, notify the National Health Insurance Service and the Health Insurance Review & Assessment Service of such fact to record and manage the details of the reduction of the upper limit amount and suspension of the application of medical care benefits.

법 제41조의2제2항 및 제3항에서 "대통령령으로 정하는 기간"이란 각각 5년을 말한다. <개정 2019.6.11>

The "period prescribed by Presidential Decree" in Article 41-2 (2) and (3) of the Act shall each refer to five years. <Amended June 11, 2019>

보건복지부장관은 법 제41조의2제1항 또는 제2항에 따른 상한금액 감액의 대상이 되는 약제 중 다음 각 호의 어느 하나에 해당하는 약제에 대해서는 상한금액을 감액하지 아니할 수 있다.

  1. 1. 퇴장방지의약품(환자의 진료에 반드시 필요하나 경제성이 없어 「약사법」에 따른 제조업자ㆍ위탁제조판매업자ㆍ수입자가 생산 또는 수입을 기피하는 약제로서 보건복지부장관이 지정ㆍ고시하는 의약품을 말한다. 이하 같다)

  2. 2. 희귀의약품(적절한 대체의약품이 없어 긴급히 생산 또는 수입하여야 하는 약제로서 식품의약품안전처장이 정하는 의약품을 말한다. 이하 같다)

  3. 3. 저가의약품(상한금액이 보건복지부장관이 정하여 고시하는 기준금액 이하인 약제로서 보건복지부장관이 정하여 고시하는 의약품을 말한다)

The Minister of Health and Welfare may not reduce the upper limit amount for drugs that are subject to reduction of the upper limit amount pursuant to Article 41-2 (1) or (2) of the Act, if such drugs fall under any of the following categories: 1. Drugs for the prevention of discontinuation of supply (referring to drugs that are essential for patient treatment but for which manufacturers, contract manufacturers, or importers pursuant to the Pharmaceutical Affairs Act are reluctant to produce or import due to lack of economic feasibility, and which are designated and publicly notified by the Minister of Health and Welfare. Hereinafter the same shall apply) 2. Orphan drugs (referring to drugs that need to be urgently produced or imported due to the absence of adequate alternative drugs, and which are prescribed by the Minister of Food and Drug Safety. Hereinafter the same shall apply) 3. Low-priced drugs (referring to drugs whose upper limit amount is below the standard amount designated and publicly notified by the Minister of Health and Welfare, and which are designated and publicly notified by the Minister of Health and Welfare)

법 제41조의2제1항부터 제3항까지의 규정에 따른 약제에 대한 상한금액의 감액 및 요양급여의 적용 정지 기준은 별표 4의2와 같다.

The criteria for the reduction of the upper limit amount for drugs and the suspension of the application of medical care benefits pursuant to Article 41-2 (1) through (3) of the Act shall be as set forth in Attached Table 4-2.

Translation

Machine translation. The Korean text is authoritative.

Statute text is reproduced from 법제처 국가법령정보센터. This is information, not legal advice.

Enforcement Decree of the National Health Insurance Act 제18조의2 — Article 18-2 (Criteria for Reduction of Upper Limit Amount of Medical Care Benefit Costs for Drugs and Suspension of Application of Medical Care Benefits, etc.) · Law4Kor