Chapter VII Medical Care Providers, Long-Term Care Providers and Midwifery Care Providers (Articles 49 to 54)
The law as Act on the Arrangement of Related Acts upon the Enforcement of the Act Partially Amending the Civil Code, etc. (Act No. 46 of 2026) leaves it, with the words it changes marked.
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Chapter VII Medical Care Providers, Long-Term Care Providers and Midwifery Care Providers第七章 医療機関、介護機関及び助産機関
Article 49第四十九条
Designation of Medical Care Providers(医療機関の指定)
Article 49, paragraph (1)
The Minister of Health, Labour and Welfare shall designate the providers in charge of the medical care for medical assistance under this Act with regard to hospitals or clinics, or pharmacies, established by the State, and a prefectural governor shall designate such providers with regard to any other hospitals or clinics (including institutions that are specified by a Cabinet Order as being equivalent to such hospitals or clinics), or pharmacies.
Application for Designation and Standards(指定の申請及び基準)
Article 49-2, paragraph (1)
The designation under the preceding Article by the Minister of Health, Labour and Welfare is to be made upon application by the establisher of a hospital or clinic, or of a pharmacy, as provided by Order of the Ministry of Health, Labour and Welfare.
In the case where an application under the preceding paragraph has been filed, the Minister of Health, Labour and Welfare must not make the designation under the preceding Article if any of the following items applies:
the hospital or clinic, or pharmacy, pertaining to the application is not a medical institution providing services covered by health insurance or a pharmacy providing services covered by health insurance prescribed in Article 63, paragraph (3), item (i) of the Health Insurance Act (Act No. 70 of 1922);
when the applicant has been sentenced to imprisonment or a severer punishment and execution of said sentence has not yet been completed or has not yet expired;
when the applicant is punished by a fine pursuant to the provisions of this Act or another Act pertaining to health and medical care or public aid for citizens as determined by a Cabinet Order and execution of said penalty has not yet been completed or has not yet expired;
the applicant is a person whose designation has been rescinded pursuant to Article 51, paragraph (2) and for whom five years have not elapsed from the date of the rescission (including a person who was, within 60 days before the date on which the notice under Article 15 of the Administrative Procedure Act pertaining to the disposition of the rescission was given, the administrator of the hospital or clinic, or pharmacy, whose designation was rescinded, and for whom five years have not elapsed from the date of the rescission); except where the case falls under a case specified by Order of the Ministry of Health, Labour and Welfare as one for which it is found appropriate not to treat it as falling under the main clause of this item, in consideration of the degree of responsibility the applicant had regarding the facts that were the grounds for the disposition of rescission of the designation;
the applicant is a person who gave notice of declination of the designation pursuant to Article 51, paragraph (1) (excluding a person with reasonable grounds for the declination of the designation) during the period from the date on which the notice under Article 15 of the Administrative Procedure Act pertaining to the disposition of rescission of the designation under Article 51, paragraph (2) was given to the date of making the disposition or the date of deciding not to make the disposition, and for whom five years have not elapsed from the date of the notice of declination;
the applicant is a person who gave notice of declination of the designation pursuant to Article 51, paragraph (1) (excluding a person with reasonable grounds for the declination of the designation) during the period from the date on which the inspection under Article 54, paragraph (1) was conducted to the scheduled hearing decision date (meaning the specific date, where the Minister of Health, Labour and Welfare has notified the applicant, as provided by Order of the Ministry of Health, Labour and Welfare and within 10 days from the date on which the inspection was conducted, of a specific date as the date on which it is expected to be decided, based on the results of the inspection, whether to hold a hearing on the disposition of rescission of the designation under Article 51, paragraph (2)), and for whom five years have not elapsed from the date of the notice of declination;
in the case where notice of declination of the designation pursuant to Article 51, paragraph (1) was given within the period prescribed in item (v), the applicant (excluding a person with reasonable grounds for the declination of the designation) is a person who was, within 60 days before the date of the notice referred to in that item, the administrator of the hospital or clinic, or pharmacy, pertaining to the notice of declination, and for whom five years have not elapsed from the date of the notice of declination;
the applicant is a person who, within five years before the application for designation, committed an illegal or grossly unjust act relating to the medical care of public assistance recipients; or
申請者が、指定の申請前五年以内に被保護者の医療に関し不正又は著しく不当な行為をした者であるとき。
Article 49-2, paragraph (2), item (ix)
the administrator of the hospital or clinic, or pharmacy, pertaining to the application is a person falling under any of items (ii) through the preceding item.
In the case where an application under paragraph (1) has been filed, the Minister of Health, Labour and Welfare may refrain from making the designation under the preceding Article if the hospital or clinic, or pharmacy, pertaining to the application falls under any of the following items:
it has repeatedly received guidance under Article 50, paragraph (2), regarding the medical care of public assistance recipients, on the grounds that there is a risk of lacking appropriateness in its content;
beyond what is provided for in the preceding item, it is found to be extremely inappropriate as a provider to be in charge of medical care for medical assistance.
前号のほか、医療扶助のための医療を担当させる機関として著しく不適当と認められるものであるとき。
Article 49-2, paragraph (4)
The provisions of the preceding three paragraphs apply mutatis mutandis to the designation under the preceding Article by a prefectural governor. In this case, the term "clinic" in paragraph (1) is deemed to be replaced with "clinic (including those specified by the Cabinet Order referred to in the preceding Article; the same applies in the following paragraph and paragraph (3))", and the term "or a pharmacy providing services covered by health insurance" in paragraph (2), item (i) is deemed to be replaced with "or a pharmacy providing services covered by health insurance, or an office or facility specified by Order of the Ministry of Health, Labour and Welfare".
The designation under Article 49 loses its effect upon the lapse of the period unless it is renewed every six years.
第四十九条の指定は、六年ごとにその更新を受けなければ、その期間の経過によつて、その効力を失う。
Article 49-3, paragraph (2)
In the case where an application for renewal under the preceding paragraph has been filed, if the disposition on the application has not been made by the day of expiry of the period under that paragraph (hereinafter referred to in this Article as the "validity period of designation"), the previous designation remains in force even after the expiry of the validity period of designation until the disposition is made.
In a case as set forth in the preceding paragraph, when the designation is renewed, the validity period of designation is to be from the date following the date of expiry of the prior validity period of designation.
The provisions of the preceding Article and Article 68, paragraph (2) of the Health Insurance Act apply mutatis mutandis to the renewal of the designation under paragraph (1). In this case, necessary technical replacement of terms is to be specified by Cabinet Order.
Obligations of Designated Medical Care Providers(指定医療機関の義務)
Article 50, paragraph (1)
A designated medical care provider shall provide medical care to public assistance recipients considerately and meticulously, in accordance with the rules provided by the Minister of Health, Labour and Welfare.
A designated medical care provider shall follow any guidance provided by the Minister of Health, Labour and Welfare or a prefectural governor with regard to medical care for public assistance recipients.
A designated medical care provider shall, when there has been a change to the name of said designated medical care provider or any other matters specified by an Ordinance of the Ministry of Health, Labour and Welfare, or when having discontinued, suspended or resumed the operations of said designated medical care provider, notify the Minister of Health, Labour and Welfare or prefectural governor who has made the designation under Article 49 to that effect within ten days, pursuant to the provisions of an Ordinance of the Ministry of Health, Labour and Welfare.
Declination and Rescission of Designation(指定の辞退及び取消し)
Article 51, paragraph (1)
A designated medical care provider may decline the designation by giving advance notice of thirty days or more.
指定医療機関は、三十日以上の予告期間を設けて、その指定を辞退することができる。
Article 51, paragraph (2)
When a designated medical care provider falls under any of the following items, the Minister of Health, Labour and Welfare, in the case of a medical care provider designated by the Minister of Health, Labour and Welfare, and a prefectural governor, in the case of a medical care provider designated by a prefectural governor, may rescind the designation or suspend the whole or part of the effect of the designation for a specified period:
When a designated medical care provider has come to fall under any of the items of Article 49-2, paragraph (3);
指定医療機関が、第四十九条の二第三項各号のいずれかに該当するに至つたとき。
Article 51, paragraph (2), item (iii)
When a designated medical care provider has violated the provisions of Article 50 or the following Article;
指定医療機関が、第五十条又は次条の規定に違反したとき。
Article 51, paragraph (2), item (iv)
When there has been any impropriety in a claim for medical treatment fees by a designated medical care provider;
指定医療機関の診療報酬の請求に関し不正があつたとき。
Article 51, paragraph (2), item (v)
When a designated medical care provider, having been ordered pursuant to the provisions of Article 54, paragraph (1) to make a report or to submit or present clinical records, books and documents or other articles, has failed to comply with the order, or has made a false report;
When an establisher or a worker of a designated medical care provider, having been requested to appear pursuant to the provisions of Article 54, paragraph (1), has failed to comply, has failed to answer or has given a false answer to questions under the provisions of that paragraph, or has refused, obstructed or avoided an inspection under the provisions of that paragraph; however, this excludes the case where, when a worker of the designated medical care provider has committed such an act, the establisher of the designated medical care provider has exercised due care and supervision in order to prevent the act;
When a designated medical care provider has received the designation under Article 49 by fraudulent means;
指定医療機関が、不正の手段により第四十九条の指定を受けたとき。
Article 51, paragraph (2), item (viii)
In addition to the cases listed in the preceding items, when a designated medical care provider has violated this Act, any other Act relating to the health, medical care or welfare of the people that is specified by Cabinet Order, or an order or disposition based on these Acts;
In addition to the cases listed in the preceding items, when a designated medical care provider has engaged in a fraudulent or grossly unjust act in relation to medical care for public assistance recipients;
前各号に掲げる場合のほか、指定医療機関が、被保護者の医療に関し不正又は著しく不当な行為をしたとき。
Article 51, paragraph (2), item (x)
When the administrator of a designated medical care provider is a person who engaged in a fraudulent or grossly unjust act in relation to medical care for public assistance recipients within five years before the time when the rescission of the designation or the suspension of the whole or part of the effect of the designation is about to be carried out.
Medical Treatment Policy and Medical Treatment Fees(診療方針及び診療報酬)
Article 52, paragraph (1)
The medical treatment policy and the medical treatment fees of a designated medical care provider shall be in accordance with the medical treatment policy and the medical treatment fees of the National Health Insurance.
指定医療機関の診療方針及び診療報酬は、国民健康保険の診療方針及び診療報酬の例による。
Article 52, paragraph (2)
In the case where the medical treatment policy and the medical treatment fees prescribed in the preceding paragraph cannot be adopted or are considered inappropriate, the medical treatment policy and the medical treatment fees shall be in accordance with the rules provided by the Minister of Health, Labour and Welfare.
Examination and Payment of Medical Expenses(医療費の審査及び支払)
Article 53, paragraph (1)
A prefectural governor may examine the contents of medical treatment provided by and the claims for medical treatment fees made by a designated medical care provider as needed and decide the amount of the medical treatment fees that the designated medical care provider may claim pursuant to the provisions of the preceding Article.
A designated medical care provider shall follow the decision under the preceding paragraph made by a prefectural governor.
指定医療機関は、都道府県知事の行う前項の決定に従わなければならない。
Article 53, paragraph (3)
When a prefectural governor decides on the amount of medical treatment fees that a designated medical care provider may claim pursuant to the provisions of paragraph (1), he/she shall hear the opinion of an examination committee prescribed in the Act on the Medical Information Infrastructure and Medical Fee Examination and Payment Organization (Act No. 129 of 1948) or an examination organ related to medical care that has been specified by Cabinet Order.
A prefecture, city, or a town or village with a welfare office may entrust affairs concerning the payment of medical treatment fees to designated medical care providers to the Medical Information Infrastructure and Medical Fee Examination and Payment Organization or a person specified by an Order of the Ministry of Health, Labour and Welfare.
No request for review may be made with regard to a decision on the amount of the medical treatment fees under the provisions of paragraph (1).
第一項の規定による診療報酬の額の決定については、審査請求をすることができない。
Article 54第五十四条
Reports(報告等)
Article 54, paragraph (1)
A prefectural governor (the Minister of Health, Labour and Welfare or a prefectural governor, in the case of a designated medical care provider designated by the Minister of Health, Labour and Welfare) may, when finding it necessary with regard to medical assistance, order a designated medical care provider, or a person who was the establisher, administrator, doctor, pharmacist or other worker of a designated medical care provider (hereinafter in this paragraph referred to as a "former establisher, etc."), to report on matters found necessary or to submit or present clinical records, books and documents or other articles, request the establisher, administrator, doctor, pharmacist or other worker of a designated medical care provider (including a former establisher, etc.) to appear, or have a relevant official question persons concerned, or inspect on-site at the designated medical care provider its equipment or clinical records, books and documents or other articles.