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. 

      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.