發文單位：司法院
解釋字號：釋字第524號
解釋日期：民國90年4月20日
解釋爭點：健保法第31條及授權所定之醫療辦法等規定違憲？
資料來源：司法院公報 第 43 卷 6 期 5-18 頁
                    司法院大法官解釋（十四）（99年5月版）第 140-161 頁
                    總統府公報 第 6400 號 27-45 頁

相關法條：全民健康保險法 第 31、39、41、5、50、51 條 ( 90.01.30 )
                    全民健康保險醫事服務機構醫療服務審查辦法 第 20 條 ( 90.02.23 )
                    全民健康保險醫療辦法 第 31 條 ( 84.02.24 )

解釋文：
全民健康保險為強制性之社會保險，攸關全體國民之福祉至鉅，故對於因保險所生之權利義務應有明確之規範，並有法律保留原則之適用。若法律就保險關係之內容授 權以命令為補充規定者，其授權應具體明確，且須為被保險人所能預見。又法律授權主管機關依一定程序訂定法規命令以補充法律規定不足者，該機關即應予以遵 守，不得捨法規命令不用，而發布規範行政體系內部事項之行政規則為之替代。倘法律並無轉委任之授權，該機關即不得委由其所屬機關逕行發布相關規章。
全民健康保險法第三十九條係就不在全民健康保險給付範圍之項目加以規定，其立法用意即在明確規範給付範圍，是除該條第一款至第十一款已具體列舉不給付之項目外，依同條第十二款規定：「其他經主管機關公告不給付之診療服務及藥品」，主管機關自應參酌同條其他各款相類似之立法意旨，對於不給付之診療服務及藥品， 事先加以公告。又同法第三十一條規定：「保險對象發生疾病、傷害或生育事故時，由保險醫事服務機構依本保險醫療辦法，給予門診或住院診療服務；醫師並得交 付處方箋予保險對象至藥局調劑。」「前項醫療辦法，由主管機關擬訂，報請行政院核定後發布之。」「第一項藥品之交付，依藥事法第一百零二條之規定辦理。」 內容指涉廣泛，有違法律明確性原則，其授權相關機關所訂定之健康保險醫療辦法，應屬關於門診或住院診療服務之事項，中華民國八十四年二月二十四日發布之全 民健康保險醫療辦法，不僅其中有涉及主管機關片面變更保險關係之基本權利義務事項，且在法律無轉委任之授權下，該辦法第三十一條第二項，逕將高科技診療項目及審查程序，委由保險人定之，均已逾母法授權之範圍。另同法第四十一條第三款：「經保險人事前審查，非屬醫療必需之診療服務及藥品」，對保險對象所發生 不予給付之個別情形，既未就應審查之項目及基準為明文規定，亦與保險對象權益應受保障之意旨有違。至同法第五十一條所謂之醫療費用支付標準及藥價基準，僅係授權主管機關對醫療費用及藥價之支出擬訂合理之審核基準，亦不得以上開基準作為不保險給付範圍之項目依據。上開法律及有關機關依各該規定所發布之函令與 本解釋意旨不符部分，均應於本解釋公布之日起兩年內檢討修正。

理由書：
全民健康保險之被保險人、投保單位及保險醫事服務機構對保險人核定之案件發生爭議，應由主管機關所設置之全民健康保險爭議審議委員會先行審議，被保險人及投 保單位對爭議案件之審議不服時，其救濟途徑為訴願及行政訴訟程序，此觀全民健康保險法第五條之規定甚明。本件係被保險人對保險人核定醫療給付事項發生爭 議，應循上開爭議程序處理，非屬民事事件，惟事件發生於行政訴訟新制施行之前，既經民事確定終局判決，仍予受理解釋，合先說明。
        全民健康保險為強制性之社會保險，攸關全體國民之福祉至鉅，故對於因保險所生之權利義務應有明確之規範，並有法律保留原則之適用，與商業保險之內容主要由當 事人以契約訂定者有別。若法律就保險關係之內容授權以命令為補充規定者，其授權應具體明確，且須為被保險人所能預見。又法律授權主管機關依一定程序訂定法規命令以補充法律規定不足者，該機關即應予以遵守，不得捨法規命令不用，而發布規範行政體系內部事項之行政規則為之替代。倘法律並無轉委任之授權，該機關即不得委由其所屬機關逕行發布相關規章。
全民健康保險法第三十九條係就不在全民健康保險給付範圍之項目加以規定，其立法用意即在明確規範給付範圍，是除該條第一款至第十一款已具體列舉不給付之項目外，依同條第十二款規定：「其他經主管機關公告不給付之診療服務及藥品」，主管機關自應參酌同條其他各款相類似之立法意旨，對於不給付之診療服務及藥品， 事先加以公告，尚不能捨棄該款而發布規章另作其他不為給付之除外規定。若為避免醫療資源之濫用或基於醫藥科技之發展，認上開法律第三十九條第十二款之規定 仍有不足，自得於法律中增訂或另立具體明確之授權條款，以應實際需要並符法律保留原則。
全民健康保險法第三十一條規定：「保險對象發生疾病、傷害或生育事故時，由保險醫事服務機構依本保險醫療辦法，給予門診或住院診療服務；醫師並得交付處方箋 予保險對象至藥局調劑。」「前項醫療辦法，由主管機關擬訂，報請行政院核定後發布之。」「第一項藥品之交付，依藥事法第一百零二條之規定辦理。」內容指涉廣泛，有違法律明確性原則，其授權相關機關所訂定之全民健康保險醫療辦法，應屬關於門診或住院診療服務之事項。行政院衛生署八十四年二月二十四日訂定發布之全民健康保險醫療辦法第三十一條第一項：「特約醫院執行高科技診療項目，應事前報經保險人審查同意，始得為之。」第二項：「前項高科技診療項目及審查程序，由保險人定之。」其第一項涉及主管機關片面變更保險關係之基本權利義務（八十九年十二月二十九日修正發布之全民健康保險醫事服務機構醫療服務審查辦法 第二十條規定亦同），其第二項在法律無轉委任之授權下，逕將高科技診療項目及審查程序，委由保險人定之，均已逾越母法授權範圍。另同法第四十一條第三款： 「經保險人事前審查，非屬醫療必需之診療服務及藥品」，對保險對象所發生不予給付之個別情形，既未就應審查之項目及基準為明文規定，又不問有無採取緊急救 濟之必要，一律限於事前審查，亦與保險對象權益應受保障之意旨有違。至同法第五十條第一項：「保險醫事服務機構應依據醫療費用支付標準及藥價基準，向保險 人申報其所提供醫療服務之點數及藥品費用。」第五十一條第一項：「醫療費用支付標準及藥價基準，由保險人及保險醫事服務機構共同擬訂，報請主管機關核 定。」雖係顧及醫療資源合理分配，授予主管機關對醫療費用及藥價之支出，擬訂合理之審核基準，尚不得以上開基準作為不保險給付範圍之項目依據。按特殊診療 項目及藥材，包括所謂危險性高的醫療服務、易為醫療人員不當或過度使用之醫療服務、高科技診療項目、特殊原因之醫療服務、價格昂貴或有明顯副作用之藥物， 法律（醫療法、藥事法等）均有規範，主管機關已知之甚稔，不難純就全民健康保險特殊診療項目及藥材給付範圍，諸如：醫療費用支付標準、藥事服務項目及藥價基準等，以法律或法律具體明確授權條款預為規定，並加以事前公告。若由法律籠統授權之法規命令，以高科技診療項目、高危險醫療服務等，就保險給付加以排 除，已有未合，況由未經法律明確授權而任由所屬機關發布規範行政體系內部事項之行政規則，諸如：全民健康保險特殊診療項目及藥材事前審查作業要點（中央健康保險局八十六年一月十一日修正公告）、全民健康保險高科技診療項目及審查程序作業要點（中央健康保險局八十五年十一月十三日公告）為之替代，於法律保留 原則尤屬有違。上開法律及有關機關依各該規定所發布之函令與本解釋意旨不符部分，均應於本解釋公布之日起兩年內檢討修正。又本院釋字第四七二號解釋所釋各 項，迄今已逾二年，未見有所措置，於本次修正時，亦應一併注意及之，特此指明。

J. Y. Interpretation No.   524
Date：2001.4.20
Issue：Are some provisions of the National Health Insurance Act inconsistent with the doctrine of legal reservation?
Holding：
National health insurance, having to do with the welfare of all citizens, is a kind of compulsory social insurance; therefore, the rights or obligations relating to the insurance should be clearly defined and regulated by the doctrine of legal reservation. If the enabling statute stipulates the supplementation of its rules in regulations on the contents of insurance relations, the stipulation should be concrete and clear and should be foreseeable by the insured. Furthermore, if the enabling statute delegates to the relevant authority the promulgation of regulations according to some specified procedure to fill the gaps in the statute, the agency should abide by this procedure—it should avoid the form of regulations with administrative rules which have validity only within the administrative organization to substitute for the regulations. If the enabling statute does not provide for further delegation , the agency cannot delegate its subordinate agencies to promulgate those related rules.

The legislative purpose of Article 39 of the National Health Insurance Act, which concerns the items not covered by national health insurance, is to clearly define the limits of coverage. Accordingly, except for those uncovered items which are listed in Subparagraphs 1-11 of the same Article, the relevant authority, when it implements Subparagraph 12, which provides: “other treatments and drugs promulgated by the relevant authority not to be covered,” should consider the legislative purposes of similar Subparagraphs of the same Article to ex ante indicate those medical services and drugs which are not covered. Article 31 of the same Act provides that: “In case of illness, injury, or maternity of the beneficiary, the contracted medical care institutions shall provide ambulatory or hospital care pursuant to the Medical Benefit Regulations of this Insurance. Physicians maydeliver prescriptions to the beneficiary to be dispensed by the pharmacy.” “The Medical Benefit Regulations mentioned in the preceding paragraph shall be drafted by the relevant authority and submitted to the Executive Yuan for approval before promulgation.” “The delivery of medication, referred to in Paragraph 1, shall be made in accordance with Article 102 of the Pharmaceutical Act.” The content of this article is too broad to be consistent with the principle of clarity of law. The Medical Benefit Regulations, which the relevant authority has the delegated power to promulgate, concern clinical and in-hospital treatments. Among the Medical Benefit Regulations of National Health Insurance promulgated on February 24, 1995, there are some provisions that enable the relevant authority to unilaterally change the fundamental rights or obligations concerning the insurance relations. Article 31, Paragraph 2, without any legal provision authorizing a chain of delegation, assigns the insurer the power to define the high technology items and to determine their review procedure. These practices are beyond the scope of statutory delegation. Furthermore, Article 41, Subparagraph 3, which provides: “Treatment and drugs which are not medically necessary according to the pre-examination by the Insurer,” does not make explicit the standards and what factors should be considered to determine which items should not be covered in individual cases. This is contrary to the principle protecting the insured’s rights and interests. With regard to Article 51 of the same Act concerning the so-called standards to determine payment for medical treatments and drugs, its scope is confined to authorizing the relevant authority to set up standards to review the reasonableness of payments for medical treatments and drugs. Those standards should not be invoked to exclude items from insurance coverage. Those laws and administrative rules which are not consistent with this Interpretation should be reviewed and corrected within two years after the promulgation of this Interpretation.

Reasoning：
According to Article 5 of the National Health Insurance Act, it is obvious that under national health insurance, whenever the insured, insuring entities or contracted medical care institutions contest cases approved by the insurer, the NHI Disputes Review and Settlement Committee set up by the relevant authority has the first jurisdiction over their review, then the insured or insurant entities may file administrative appeals or litigation as remedy, if they do not agree with this Committee’s decisions. However, as this case arose before the new administrative litigating procedure came into effect and has been finally determined by the civil courts, we will still consider this case, even though this case is concerned with the dispute brought by the insured to contest compensation cases approved by the insurer and therefore the administrative procedure mentioned above should apply.

National health insurance, having to do with the welfare of all citizens, is a kind of compulsory social insurance; therefore, the rights or obligations relating to the insurance should be clearly defined and regulated by the doctrine of legal reservation. It is different from commercial insurance, whose contents have largely been determined by contracting parties. If the enabling statute stipulates the supplementation of its rules in regulations on the contents of the insurance relationship, the stipulation should be concrete and clear and should be foreseeable by the insured. Furthermore, if the enabling statute delegates to the relevant authority the promulgation of regulations according to some specified procedure to fill the gaps in the statute, the agency should abide by this procedure—it should? avoid the form of regulations with administrative rules which have validity only within the administrative organization to substitute for the regulations. If the enabling statute does not provide for further delegation, the agency cannot delegate its subordinate agencies to promulgate those related rules.

The legislative purpose of Article 39 of the National Health Insurance Act, which concerns the items not covered by national health insurance, is to clearly define the limits of coverage. Accordingly, except for those uncovered items which are listed in Subparagraphs 1-11 of the same Article, the relevant authority, when it implements Subparagraph 12, which provides: “other treatments and drugs promulgated by the relevant authority not to be covered,” should consider the legislative purposes of similar Subparagraphs of the same Article to ex ante indicate those medical services and drugs which are not covered. The relevant authority cannot avoid application of this Subparagraph and promulgate other exception rules to list uncovered items. If it is deemed that the provisions of Article 39, Subparagraph 12, are not sufficient to prevent the abuse of medical resources or to accommodate the developments in medical or pharmaceutical technology, power-conferring clauses with concreteness and clarity may be added to the enabling statute, which should be both responsive to practical needs and consistent with the doctrine of legal reservation.

Article 31 of the same act provides that: “In case of illness, injury, or maternity of the beneficiary, the contracted medical care institutions shall provide ambulatory or hospital care pursuant to the Medical Benefit Regulations of this Insurance. Physicians may [shall?] deliver prescriptions to the beneficiary to be dispensed by the pharmacy.” “The Medical Benefit Regulations mentioned in the preceding paragraph shall be drafted by the relevant authority and submitted to the Executive Yuan for approval before promulgation.” “The delivery of medication, referred to in Paragraph 1, shall be made in accordance with Article 102 of the Pharmaceutical Act.” The content of this article is too broad to be consistent with the principle of clarity of law. Article 31, Paragraph 1, of the Medical Benefit Regulations of the National Health Insurance promulgated by the Department of Health, Executive Yuan, on February 24, 1995, provides that: “To perform medical treatments involving high technology, contracted hospitals should ex ante obtain approval from the insurer.” The following paragraph provides that: “the high technology items and reviewing process of the preceding paragraph shall be determined by the insurer.” Paragraph 1 enables the relevant authority to unilaterally change the fundamental rights or obligations concerning the insurance relations (Article 20 of the Regulations as amended December 29, 2000, has the same stipulation). Paragraph 2, without any legal provision authorizing a chain of delegation, assigns the insurer the power to define the items concerning high technology and to determine their review procedure. These practices are beyond the scope of statutory delegation. Furthermore, Article 41, Subparagraph 3, which provides: “other treatments and drugs promulgated by the relevant authority not to be covered,” not only does not make explicit the standard and what factors should be considered to determine which items should not be covered in individual cases, but also universally requires ex ante approval without taking account of emergency treatments. This is contrary to the principle protecting the insured’s rights and interests. Article 50, Paragraph 1, provides that: “The contracted medical care institutions shall declare to the insurer the points of the medical services rendered and expense of drugs, based on the Fee Schedule for Medical Services and the Reference List for Drugs.” Article 51, Paragraph 1, provides that: “The Fee Schedule for Medical Services and Reference List for Drugs shall be established jointly by the insurer and the contracted medical care institutions and reported to the relevant authority for approval.” Although the purpose of the provisions is to authorize the relevant authority, for the sake of rationally allocating medical resources, to set up reasonable standards to review costs of medical treatments and drugs, these provisions should not be interpreted as the basis for items excluded from insurance coverage. Those special medical treatments and drugs, such as so-called high-risk medical services, medical services easily abused or overused by medical staff, high-technology items, medical services for special causes, expensive drugs or drugs with serious side effects, have already been regulated by laws (See the Medical Service Law, Pharmaceutical Act, etc. ). The relevant authority knows that it would not be difficult to directly write into law or indirectly delegate with concreteness and clarity to publish ex ante the scopes and items for special cases in national health insurance, such as reimbursement standards for medical expenses, items of pharmaceutical service, and the basis for pricing drugs. The statutory regulations, which do not have clear and concrete delegation based on the enabling law, having excluded high technology and high risk medical services from insurance coverage, therefore, run counter to law. Moreover, subordinate agencies, without clear delegation, promulgate administrative rules which have validity only within administrative organizations, such as the Rules for the ex ante Review of Medical Treatment Items and Drugs for Special Causes in the National Health Insurance (as amended and promulgated on January 11, 1997, by the Bureau of National Health Insurance) and the Rules for the Review of Procedures and High Technology Medical Items in the National Health Insurance (promulgated on November 13, 1996, by the Bureau of National Health Insurance), that take the place of statutory regulations. This definitely is in violation of the doctrine of legal reservation. Those laws and administrative rules which are not consistent with this Interpretation should be reviewed and corrected within two years after the promulgation of this Interpretation. Moreover, those omissions which were pointed out in this Council’s Interpretation No. 472 more than two years ago should also have been taken into account in this correction since they have not yet been properly handled.

' Translated by Professor Tze-Shiou Chien.