[논문]미국의 혁신의료기술 지불보상제도: 인공지능 의료기기를 중심으로

이보람; 임재준; 양장미

doi:10.4332/kjhpa.2022.32.2.125

미국의 혁신의료기술 지불보상제도: 인공지능 의료기기를 중심으로
Medicare's Reimbursement for Innovative Technologies: Focusing on Artificial Intelligence Medical Devices 원문보기

Health policy and management = 보건행정학회지, v.32 no.2, 2022년, pp.125 - 136

이보람 (서울대학교 보건대학원) , 임재준 ((주)뷰노) , 양장미 ((주)뷰노)

Abstract ▼ AI-Helper

The costliness index (CI) is an index that is used in various ways to improve the quality of medical care and the management of appropriate treatment in medical institutions. However, the current calculation method for CI has a limitation in reflecting the actual medical cost of the patient unit because the outpatient and inpatient costs are evaluated separately. It is desirable to calculate the CI by integrating the medical cost into the episode unit. We developed an episode-based CI method using the episode classification system of the Centers for Medicare and Medicaid Services to the National Inpatient Sample data in Korea, which can integrate the admission and ambulatory care cost to episode unit. Additionally, we compared our new method with the previous method. In some episodes, the correlation between previous and episode-based CI was low, and the proportion of outpatient treatment costs in total cost and readmission rates are high. As a result of regression analysis, it is possible that the level of total medical costs of the patient unit in low volume medical institute and rural area has been underestimated. High proportion of outpatient treatment cost in total medical cost means that some medical institutions may have provided medical services in the ambulatory care that are ancillary to inpatient treatment. In addition, a high readmission rate indicates insufficient treatment service for inpatients, which means that previous CI may not accurately reflect actual patient-based treatment costs. Therefore, an integrated patient-unit classification system which can be used as a more effective CI indicator is needed.

주제어

표/그림 (2)

그림 Figure 1. Medicare's conventional and temporary payment system. IPPS, inpatient prospective payment system; OPPS, outpatient prospective payment system; MS-DRG, Medicare severity diagnosis-related group; APC, ambulatory payment classification; RBRVS, reource-based relative value scale; NTAP, new technology add-on payment; TPP, transitional pass-through.
표 Table 1. New technology add-on payment approved items for the fiscal year 2022

참고문헌 (39)

World Health Organization. Digital health [Internet]. Geneva: World Health Organization; 2018 [cited 2021 Nov 20]. Available from: https://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_R7-en.pdf.
World Health Organization. WHO guideline: recommendations on digital interventions for health system strengthening [Internet]. Geneva: World Health Organization; 2019 [cited 2021 Nov 20]. Available from: https://www.who.int/publications/i/item/9789241550505.
IMDRF SaMD Working Group. Software as a medical device (SaMD): key definitions [Internet]. [place unknown]: The International Medical Device Regulators Forum; 2013 [cited 2021 Nov 1]. Available from: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf.
Health Insurance Review and Assessment Service. Guidelines for evaluating innovative medical technology reimbursement: AI-based medical device in radiology and 3D printing medical technology. Wonju: Health Insurance Review and Assessment Service; 2019.
Health Insurance Review and Assessment Service. Guidelines for evaluating innovative medical technology reimbursement: AI-based medical device in pathology. Wonju: Health Insurance Review and Assessment Service; 2020.
Ministry of Science and ICT. Press release: Precision medicine software action plan for realizing the Korean New Deal 2.0 [Internet]. Sejong: Ministry of Science and ICT; 2021 [cited 2021 Dec 10]. Available from: https://www.msit.go.kr/bbs/view.do?sCodeuser&mId113&mPid112&pageIndex&bbsSeqNo94&nttSeqNo3180601&searchOptALL&searchTxt&fbclidIwAR2YqW4jNufed_22oNdtEKFuOiHLIin93etG6cdmR9nCVryIvigT05xorx0.
Federal Institute for Drugs and Medical Devices. The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V. Bonn: Federal Institute for Drugs and Medical Devices; 2020.
Ju JH, Sim B, Lee J, Lee JY. Reimbursement of digital therapeutics: future perspectives in Korea. Korean Circ J 2022;52(4):265-279. DOI: https://doi.org/10.4070/kcj.2022.0014.

상세보기
Ministry of Health, Labour and Welfare. Outline of revision of medical fees in Reiwa 4th year medical technology [Internet]. Tokyo: Ministry of Health, Labour and Welfare; 2022 [cited 2022 May 16]. Available from: https://www.mhlw.go.jp/content/12400000/000906922.pdf.
Centers for Medicare and Medicaid Services. CMS fast facts [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2021 [cited 2021 Dec 10]. Available from: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts.
Centers for Medicare and Medicaid Services. Physician fee schedule [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2022 [cited 2022 May 16]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched.
Centers for Medicare and Medicaid Services. Prospective payment systems: general information [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2021 [cited 2022 May 16]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ProspMedicareFeeSvcPmtGen.
Centers for Medicare and Medicaid Services. Acute inpatient PPS [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2022 [cited 2022 May 16]. Available from: https://www.cms.gov/medicare/medicare-fee-for-service-payment/acutein-patientpps.
Centers for Medicare and Medicaid Services. Hospital outpatient PPS [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2022 [cited 2022 May 16]. Available from: https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps.
U.S. Government Publishing Office. Code of Federal Regulations (annual edition) [Internet]. Washington (DC): U.S. Government Publishing Office; 2020 [cited 2021 Dec 10]. Available from: https://www.govinfo.gov/content/pkg/CFR-2020-title42-vol2/pdf/CFR-2020-title42-vol2-sec412-87.pdf.
U.S. Government Publishing Office. Code of Federal Regulations (annual edition) [Internet]. Washington (DC): U.S. Government Publishing Office; 2020 [cited 2021 Dec 10]. Available from: https://www.govinfo.gov/content/pkg/CFR-2020-title42-vol2/pdf/CFR-2020-title42-vol2-sec412-88.pdf.
Centers for Medicare and Medicaid Services. New medical services and new technologies [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services [cited 2021 Dec 10]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.
Centers for Medicare and Medicaid Services. Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system and policy changes and fiscal year 2022 rates; quality programs and Medicare promoting interoperability program requirements for eligible hospitals and critical access hospitals; changes to Medicaid provider enrollment; and changes to the Medicare shared savings program. In: Centers for Medicare and Medicaid Services, editor. Federal Register volume 86, issue 154 (August 13, 2021): rules and regulations [Internet]. Washington (DC): Office of the Federal Register, National Archives and Records Administration; 2021 [cited 2021 Dec 10]. pp. 44774-45615. Available from: https://www.govinfo.gov/content/pkg/FR-2021-08-13/pdf/2021-16519.pdf.
U.S. Food and Drug Administration. Premarket notification 510(k) [Internet]. Silver Spring (MD): Food and Drug Administration; 2020 [cited 2021 Nov 23]. Available from: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k.
Centers for Medicare and Medicaid Services. Pass-through payment status and new technology ambulatory payment classification (APC) [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2021 [cited 2021 Dec 10]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/passthrough_payment.
U.S. Government Publishing Office. Code of Federal Regulations (annual edition) [Internet]. Washington (DC): U.S. Government Publishing Office; 2020 [cited 2021 Nov 28]. Available from: https://www.govinfo.gov/content/pkg/CFR-2020-title42-vol3/pdf/CFR-2020-title42-vol3-sec419-62.pdf.
U.S. Government Publishing Office. Code of Federal Regulations (annual edition, 2020) [Internet]. Washington (DC): U.S. Government Publishing Office; 2020 [cited 2021 Nov 28]. Available from: https://www.govinfo.gov/content/pkg/CFR-2020-title42-vol3/pdf/CFR-2020-title42-vol3-sec419-66.pdf.
Centers for Medicare and Medicaid Services. List of pass through payment device category codes [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2020 [cited 2021 Dec 10]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Complet-list-DeviceCats-OPPS.pdf.
HeartFlow. HeartFlow announces decision by Centers for Medicare and Medicaid Services to assign a new technology payment classification to HeartFlow FFRCT Analysis [Internet]. Mountain View (CA): HeartFlow; 2017 [cited 2021 Oct 5]. Available from: https://www.heartflow.com/newsroom/heartflow-announces-decision-by-centers-for-medicare-medicaid-services/.
Centers for Medicare and Medicaid Services. Medicare program: changes to hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; revisions of organ procurement organizations conditions of coverage; prior authorization process and requirements for certain covered outpatient department services; potential changes to the laboratory date of service policy; changes to grandfathered children's hospitals within-hospitals; notice of closure of two teaching hospitals and opportunity to apply for available slots. In: Centers for Medicare and Medicaid Services, editor. Federal Register volume 86, issue 218 (November 12, 2019): rules and regulations [Internet]. Washington (DC): Office of the Federal Register, National Archives and Records Administration; 2019 [cited 2021 Dec 10]. pp. 61220-61221. Available from: https://www.govinfo.gov/content/pkg/FR2019-11-12/pdf/2019-24138.pdf.
HeartFlow. CMS sets national payment rate for the HeartFlow Analysis in doctors' offices and imaging centers [Internet]. Mountain View (CA): HeartFlow; 2021 [cited 2021 Dec 10]. Available from: https://www.heartflow.com/newsroom/cms-sets-national-payment-rate-for-the-heartflow-analysis-in-doctors-offices-and-imaging-centers/.
U.S. Food and Drug Administration. FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2018 [cited 2021 Nov 23]. Available from: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-artificialintelligence-based-device-detect-certain-diabetes-related-eye.
Centers for Medicare and Medicaid Services. Medicare program: hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; new categories for hospital outpatient department prior authorization process; clinical laboratory fee schedule: laboratory date of service policy; overall hospital quality star rating methodology; physician-owned hospitals; notice of closure of two teaching hospitals and opportunity to apply for available slots, radiation oncology model; and reporting requirements for hospitals and critical access hospitals (CAHs) to report COVID-19 therapeutic inventory and usage and to report acute respiratory illness during the public health emergency (PHE) for coronavirus disease 2019 (COVID-19). In: Centers for Medicare and Medicaid Services, editor. Federal Register volume 85, issue 249 (December 29, 2020): rules and regulations [Internet]. Washington (DC): Office of the Federal Register, National Archives and Records Administration; 2020 [cited 2021 Dec 10]. pp. 85960-85962. Available from: https://www.govinfo.gov/content/pkg/FR-2020-12-29/ pdf/FR-2020-12-29.pdf.
Centers for Medicare and Medicaid Services. Medicare program; CY 2022 payment policies under the physician fee schedule and other changes to part B payment policies; Medicare shared savings program requirements; provider enrollment regulation updates; and provider and supplier prepayment and post-payment medical review requirements. In: Centers for Medicare and Medicaid Services, editor. Federal Register volume 86, issue 221 (November 19, 2021): rules and regulations [Internet]. Washington (DC): Office of the Federal Register, National Archives and Records Administration; 2021 [cited 2021 Dec 10]. pp. 65037. Available from: https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/FR-2021-11-19.pdf.
Eyenuk. Eyenuk applauds CMS CY 2022 Medicare physician fee schedule final rule to establish national price for autonomous AI technology [Internet]. Woodland Hills (CA): Eyenuk; 2021 [cited 2021 Dec 20]. Available from: https://www.eyenuk.com/en/articles/eyeart/2022-cms-pfs-final-rule/.
Center for New Health Technology Assessment. Introduction of the system [Internet]. Seoul: National Evidence-based Healthcare Collaborating Agency; [date unknown] [cited 2021 Dec 10]. Available from: https://nhta.neca.re.kr/nhta/committee/nhtaU0201V.ecg.
Kim Y, Lee M. Issues and options in new health technology assessment in South Korea. In: Lee JH, Choi C, editors. Regulatory reform to foster innovation ecosystem. Sejong: Korea Development Institute; 2018. pp. 358-389.
Ministry of Food and Drug Safety. Setting international standards for artificial intelligence medical devices [Internet]. Cheongju: Ministry of Food and Drug Safety; 2021 [cited 2021 Dec 10]. Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq45794&srchFr&srchTo&srchWord%EC%9D%B8%EA%B3%B5%EC%A7%80%EB%8A%A5%28AI%29+%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0+%EA%B5%AD%EC%A0%9C%ED%91%9C%EC%A4%80&srchTp0&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&.
Ministry of Food and Drug Safety. The 17th innovative medical device is 'automated system robotic surgical device' [Internet]. Cheongju: Ministry of Food and Drug Safety; 2021 [cited 2021 Dec 10]. Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq45976&srchFr&srchTo&srchWord%ED%98%81%EC%8B%A0%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0&srchTp0&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&company_nm&Data_stts_gubunC9999&page1.
Center for New Health Technology Assessment. Assessment status [Internet]. Seoul: National Evidence-based Healthcare Collaborating Agency; [date unknown] [cited 2021 Dec 10]. Available from: https://nhta.neca.re.kr/nhta/application/nhtaU0510L.ecg.
Manz CR, Bekelman JE, Doshi JA. The changing characteristics of technologies covered by Medicare's new technology add-on payment program. JAMA Netw Open 2020;3(8):e2012569. DOI: https://doi.org/10.1001/jamanetworkopen.2020.12569.

상세보기
Kimbell JJ, Tucker CP. Improvements to Medicare's NTAP for new, innovative medical devices: Montvale: medical product outsourcing. MPO [Internet]. 2019 Apr 3 [cited 2021 Nov 16]. Available from: https://www.mpo-mag.com/issues/2019-04-01/view_columns/improvements-to-medicares-ntap-for-new-innovative-medical-devices/.
Centers for Medicare and Medicaid Services. Medicare coverage of innovative technologies (MCIT) [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2021 [cited 2021 Dec 10]. Available from: https://www.cms.gov/blog/medicare-coverage-innovative-technologies-mcit.
Chen MM, Golding LP, Nicola GN. Who will pay for AI? Radiol Artif Intell 2021;3(3):e210030. DOI: https://doi.org/10.1148/ryai.2021210030.

상세보기

표제어: PCR

동의어: Packet Collision Rate

용어 설명 출처 목록 (6)

용어 설명: PCR은 세균 특이성이 있는 primer를 이용하여 적은 수의 세균이 있을지라도 쉽게 검출할 수 있는 유용한 방법이며, 이를 이용하여 구강 내 치면세균막이나 타액에서 직접 세균을 검출할 수 있게 되었다[8].

내보내기 구분	파일저장 인쇄 메일전송
구성항목	기본정보 상세정보 관리번호, 논문명, 저널/프로시딩명, 저자 , 발행년, 권, 호, 시작페이지, 끝페이지, 발행기관 관리번호, 논문명, 대등논문명, 저자 , 저널/프로시딩명, 발행기관, 발행년, 발행언어, 권, 호, 시작페이지, 끝페이지, ISBN, ISSN, 주제분야, 키워드, 초록(한글), 초록(영문), 저자(소속기관)
저장형식	Text(ASCII format) Excel format RefWorks Direct Export RIS format (for Reference Manager, ProCite, EndNote), Scholar's Aids, Mendeley
메일정보	받는사람 (필수) @ 보내는사람 (선택) @ 제목 내용 KISTI 검색결과 이메일 서비스
안내	총 건의 자료가 검색되었습니다. 다운받으실 자료의 인덱스를 입력하세요. (1-10,000) 검색결과의 순서대로 최대 10,000건 까지 다운로드가 가능합니다. 데이타가 많을 경우 속도가 느려질 수 있습니다.(최대 2~3분 소요) 다운로드 파일은 UTF-8 형태로 저장됩니다. 파일의 내용이 제대로 보이지 않을실 때는 웹브라우저 상단의 보기 -> 인코딩 -> 자동선택 여부를 확인하십시오. ~ Text(ASCII format) Excel format

연합인증