요양급여 사전승인제도의 현황과 개선 방안

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사전승인제도고가의약품Pre-AuthorityHigh cost medicinePrior AuthorizationHigh cost drugHIRAHealth Insurance Review & Assessment
With the rapid development of high-cost drugs to treat rare diseases worldwide in recent times, discussions are actively underway to establish systems for the efficient management of health insurance finances. South Korea’s pre-approval system for reviewing the applicability of high-cost and high-risk medical services has been in operation since 1992, and it is attracting attention as an effective system for managing high-cost healthcare benefit drugs. Despite the implementation of the pre-approval system, there are yet to be studies related to the system. For the system to be established as a more efficient benefits management plan in the future, a comprehensive review of the system is required.
This study aims to identify issues in the pre-approval system through a comprehensive review and seek ways to make improvements so that a stable and systematic implementation may be realized. In this respect, this study reviewed domestic and international research literature, analyzed the current system by looking at claim documents, carried out advisory meetings with experts, and surveyed relevant academic societies.
Based on the analysis of the pre-approval system over the past five years (2017—2021), there were a total of 21,453 cases of review involving 14,289 patients, with the cost of paid medical expenses reaching KRW 9,277 billion. The number of reviews showed a steadily increasing trend over the years, with average annual increases in review cases (10.3%), claims cases (4.3%), and the number of actual patients (3.8%). The analysis of the current state confirmed the gradually growing impact of pre-approval items on health insurance finances. Furthermore, based on the literature review findings on the purpose of the system, this study proposed the following improvements: ① reestablish the purpose and functions of the system, ② set standards for the entry into and removal from the system, ③ provide a management mechanism post-removal, ④ improve the operational system, and ⑤ establish legal grounds. This study is significant in that it is the first study on the domestic pre-approval system, conducting a comprehensive review of the system. The study, however, needs a professional review of the legal grounds and necessitates reaching a consensus among departments related to the pre-approval system within the review committee and requesting the input of medical professionals to apply the entry and removal standards.
Alternative Title
A Study on the Current State of the Pre-Approval System for Healthcare Benefits and its Improvement Plan
Table Of Contents
제1장 서론 ······························································································ 1
1. 연구 배경 ······························································································ 1
2. 연구 목적 ······························································································ 5
3. 연구 내용 및 방법 ·················································································· 5

제2장 사전승인제도 현황 ······························································································ 11
1. 제도 목적 및 기능 ················································································ 11
2. 법적 근거 ···························································································· 13
3. 운영 절차 등 ······················································································· 16
4. 운영 현황 ···························································································· 20

제3장 제외국 사전승인 관련 제도 ······························································································ 55
1. 국가별 제도 현황 ················································································· 55
2. 시사점 ································································································· 81

제4장 국내 관련 의료서비스 관리제도 ······························································································ 87
1. 제도 현황 ···························································································· 87
2. 시사점 ······························································································· 114

제5장 사전승인제도 개선 방안 ······························································································ 125
1. 개선 방안 도출 과정 ··········································································· 125
2. 문제점 및 개선 방안 ··········································································· 126

제6장 결론 및 제언 ······························································································ 165

◾ 참고 문헌 ······························································································ 169
◾ 부록 ····································································································· 175
◾ ABSTRACT ·························································································· 219
윤국회. (2023-01). 요양급여 사전승인제도의 현황과 개선 방안.
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