Moon Care and Preliminary Benefit Program in South Korea: Innovative Strategies in Post-Market Evidence Generation for Medical Devices
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Objectives: The President Moon administration was launched in May 2017. The “Benefit Expansion” of the National Health Insurance (NHI) system has emerged as the core policy of the new government. It provides an overview of the health policies and programs announced by the Moon administration and suggests health policy operation for a successful and effective “Preliminary Benefit” program specific to medical devices which is one of the main drivers in the new health policies. Methods: A description of the new health policies, namely “NHI Benefit Enhancement Measures” and “Preliminary Benefit” program and a review of foreign strategies in post-market evidence generation for medical devices which provides insight for evidence generation applicable in South Korea. Results: Registries are strategic instruments to generate evidence under “Preliminary Benefit” for those medical devices which do not have sufficient evidence at the time of market entry and subsequent post-market stage. As demonstrated in the transcatheter valve therapy registry and Micra coverage with evidence development study, there are even more effective and cost-saving methods for evidence generation. There are several strategies and elements that can be considered in performing efficient medical device registries: 1) quality measure and pay-for-performance, 2) registry linking with claims datasets, 3) funding and resource provision for registry, and 4) participation in international registries. Conclusion: The “Preliminary Benefit” program under “Moon Care” is epoch-making in the benefit expansion history of NHI system. Registries are one of the promising strategies to pursue health technology reassessment required in the “Preliminary Benefit” program. The success of “Preliminary Benefit” depends on the reassessments, and the evidence generation of medical devices required for reassessment can be resolved by registries. The development of and investment in registries, and even more innovative evidence generation approaches as seen in the foreign cases, should be made for the “Preliminary Benefit” program.
Abstract
Objectives: The President Moon administration was launched in May 2017. The “Benefit Expansion” of the National Health Insurance (NHI) system has emerged as the core policy of the new government. It provides an overview of the health policies and programs announced by the Moon administration and suggests health policy operation for a successful and effective “Preliminary Benefit” program specific to medical devices which is one of the main drivers in the new health policies. Methods: A description of the new health policies, namely “NHI Benefit Enhancement Measures” and “Preliminary Benefit” program and a review of foreign strategies in post-market evidence generation for medical devices which provides insight for evidence generation applicable in South Korea. Results: Registries are strategic instruments to generate evidence under “Preliminary Benefit” for those medical devices which do not have sufficient evidence at the time of market entry and subsequent post-market stage. As demonstrated in the transcatheter valve therapy registry and Micra coverage with evidence development study, there are even more effective and cost-saving methods for evidence generation. There are several strategies and elements that can be considered in performing efficient medical device registries: 1) quality measure and pay-for-performance, 2) registry linking with claims datasets, 3) funding and resource provision for registry, and 4) participation in international registries. Conclusion: The “Preliminary Benefit” program under “Moon Care” is epoch-making in the benefit expansion history of NHI system. Registries are one of the promising strategies to pursue health technology reassessment required in the “Preliminary Benefit” program. The success of “Preliminary Benefit” depends on the reassessments, and the evidence generation of medical devices required for reassessment can be resolved by registries. The development of and investment in registries, and even more innovative evidence generation approaches as seen in the foreign cases, should be made for the “Preliminary Benefit” program.
참고문헌 (35)
- Kim Y, "Success strategy for Moon Jae-in care", pp.60~73 (2017), Medicine and Society
- Results of research for non-covered services in general hospitals, "National Health Insurance Service", Health Insurance Policy Research Institute, National Health Insurance Service, ~ (2016)
- 신성식, "문재인 대통령의 보건의료 공약과 과제", 보건행정학회지, 27(2), pp.97~102 (2017), 한국보건행정학회
- 박은철, "문재인 정부의 건강보험 보장성 강화대책", 보건행정학회지, 27(3), pp.191~198 (2017), 한국보건행정학회
- Kim Y, "Success strategy and evaluation of Moon Jae-in care", Monthly Welfare Trend, 228, pp.39~47 (2017)
- Park CY, "The role of health technology assessment in the policy for benefit expansion in national health insurance", Evidence and Values in Healthcare, 3, pp.71~77 (2017)
- Park DA, "Health technology reassessment of existing technology according to policies to strengthen healthcare insurance coverage", Evidence and Values in Healthcare, 3, pp.88~96 (2017)
- 김윤, "4대 중증질환 보장성 강화정책의 평가", 대한의사협회지, 57(3), pp.198~203 (2014), 대한의사협회[DOI]
- A study on the system and execution model for health technology reassessment, "Lee SH", National Evidence-based Healthcare Collaborating Agency, 1~151 (2014)
- Gliklich RE, "Registries for evaluating patient outcomes: a user's guide", pp.13~ (2014), Agency for Healthcare Research and Quality (AHRQ)
- 허준, "가치 기반 헬스케어: 한국에서의 정책적 실행을위한 요건 및 제안", 대한의사협회지, 60(10), pp.826~840 (2017), 대한의사협회[DOI]
- Frobert O, "Thrombus aspiration during ST-segment elevation myocardial infarction", N Engl J Med, 369, pp.1587~1597 (2013)[DOI]
- Carroll JD, "The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies", J Am Coll Cardiol, 62, pp.1026~1034 (2013)[DOI]
- "PCORI methodology standards"[URL]
- Reynolds IS, "Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies", JAMA Intern Med, 174, pp.1773~1779 (2014)[DOI]
- Mack MJ, "Rational dispersion for the introduction of transcatheter valve therapy", JAMA, 306, pp.2149~2150 (2011)
- "Unique device identification system - final rule. federal register 78, no. 185"[URL]
- Dokholyan RS, "Regulatory and ethical considerations for linking clinical and administrative databases", Am Heart J, 157, pp.971~982 (2009)[DOI]
- Hammill BG, "Linking inpatient clinical registry data to Medicare claims data using indirect identifiers", Am Heart J, 157, pp.995~1000 (2009)[DOI]
- Plan about national health insurance application for routine care costs of clinical researches with public interests, "Chung SH", Health Insurance Review and Assessment Service, ~ (2016)
- Sedrakyan A, "Stages and tools for multinational collaboration: the perspective from the coordinating center of the International Consortium of Orthopaedic Registries (ICOR)", J Bone Joint Surg Am, 93(Suppl 3), pp.76~80 (2011)
- Sedrakyan A, "The international consortium of orthopaedic registries: overview and summary", J Bone Joint Surg Am, 93(Suppl 3), pp.1~12 (2011)
- Sedrakyan A, "The international registry infrastructure for cardiovascular device evaluation and surveillance", JAMA, 310, pp.257~259 (2013)[DOI]
- "Healthcare's value problem - and how to fix it: simple rules for delivering improved health outcomes at lower cost"[URL]