Health Insurance Act

A designation referred to in Article 63, paragraph (3), item (i) is provided upon an application by the establisher who opened a hospital, clinic, or pharmacy, as specified by Cabinet Order.

In the case of the preceding paragraph, if the application pertains to a hospital or to a clinic that has beds, the application is to be made by specifying the number of beds for each classification of bed prescribed in Article 7, paragraph (2) of the Medical Care Act (simply referred to as "bed classification" in paragraph (4) and paragraph (1) of the following Article).

When an application referred to in paragraph (1) is filed and the application falls under any of the following items, the Minister of Health, Labour and Welfare may determine not to make the designation referred to in Article 63, paragraph (3), item (i):

the hospital, clinic, or pharmacy pertaining to the application is a place of business or facility whose designation under Article 63, paragraph (3), item (i) pertaining to a medical institution providing services covered by health insurance providing services covered by health insurance or a pharmacy providing services covered by health insurance has been rescinded pursuant to the provisions of this Act and five years have not elapsed from the date of the rescission;

the hospital, clinic or pharmacy pertaining to the relevant application has received repeated guidance due to a likelihood of inappropriate medical care or prescriptions with respect to insurance benefits pursuant to Article 73, paragraph (1) (including when applied mutatis mutandis to Article 85, paragraph (9), Article 85-2, paragraph (5), Article 86, paragraph (5), Article 110, paragraph (7), and Article 149);

When an application referred to in paragraph (1) is filed pertaining to a hospital or clinic referred to in paragraph (2) and the application falls under any of the following items, the Minister of Health, Labour and Welfare may make the designation prescribed in Article 63, paragraph (3), item (i) excluding all or some of the beds pertaining to the application:

the number of physicians, dentists, nurses and other employees at the hospital or clinic does not meet the requirements for the number specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 21, paragraph (1), item (i) or paragraph (2), item (i) of the Medical Care Act or the number calculated based on the standards specified by the Minister of Health, Labour and Welfare in consideration of the standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in paragraph (3) of the same Article;

it is found that the number of beds, according to the bed classification related to the application, at a medical institution providing services covered by health insurance in a region prescribed by Article 7-2, paragraph (1) of the Medical Care Act will, as a result of the designation, exceed the number calculated as specified by the Minister of Health, Labour and Welfare in consideration of the standard number of beds specified in the medical care plan prescribed in Article 30-4, paragraph (1) of the same Act (including where that number is already exceeded), and the establisher or administrator of the hospital or clinic has received a recommendation from the prefectural governor pursuant to the provisions of Article 30-11, paragraph (1) of the same Act but does not comply with the recommendation;

if all of the following apply, and the establisher or administrator of the hospital or clinic has received a recommendation from the prefectural governor pursuant to the provisions of Article 30-11, paragraph (1) of the Medical Care Act and does not comply with it;

where it is found that, in accordance with the bed classification pertaining to the relevant application, the number of beds at medical institutions providing services covered by health insurance in the area prescribed in Article 7-2, paragraph (1) of the Medical Care Act would, as a result of the designation, fall short of the number calculated pursuant to the rules prescribed by the Minister of Health, Labour and Welfare taking into account the standard number of beds determined in the medical care plan prescribed in Article 30-4, paragraph (1) of that Act;

where it is found that, in accordance with the bed classification pertaining to the relevant application, the number of beds at medical institutions providing services covered by health insurance in the vision area prescribed in Article 30-3-3, paragraph (2), item (ii) of the Medical Care Act would, as a result of the designation, exceed the number calculated pursuant to the rules prescribed by the Minister of Health, Labour and Welfare taking into account the required number of beds in the future (meaning the required number of beds in the future prescribed in item (iv) of that paragraph; the same applies in the following item) determined in the regional medical care vision prescribed in paragraph (1) of that Article (including where that number has already been exceeded);

it is found that, in accordance with the bed classification pertaining to the application, the number of beds at a medical institution providing services covered by health insurance in a regional healthcare vision area prescribed in Article 30-3-3, paragraph (2), item (ii) of the Medical Care Act will, as a result of the designation, exceed the number calculated as specified by the Minister of Health, Labour and Welfare in consideration of the required number of beds in the future specified in the regional medical care vision prescribed in paragraph (1) of that Article (including where that number is already exceeded), and the establisher or administrator of the hospital or clinic has received a recommendation from the prefectural governor pursuant to the provisions of Article 30-11, paragraph (1) of the same Act but does not comply with the recommendation; or

it is found that the use of beds at the hospital or clinic is significantly inappropriate for a medical institution providing services covered by health insurance from the viewpoint of efficiently providing appropriate medical care.

When intending to increase the number of beds or to alter bed classifications related to the designation pursuant to Article 63, paragraph (3), item (i), the establisher of the hospital or clinic referred to in paragraph (2) of the preceding Article must apply for a change of designation referred to in the same item pertaining to the hospital or clinic pursuant to Order of the Ministry of Health, Labour, and Welfare.

The provisions of paragraph (4) of the preceding Article apply mutatis mutandis to an application for alteration of designation referred to in the preceding paragraph.

When the Minister of Health, Labour and Welfare determines to not make a designation referred to in Article 63, paragraph (3), item (i) pertaining to a medical institution providing services covered by health insurance, determines to make a designation excluding all or some of the beds pertaining to that medical institution's application (including an alternation of such a designation), or determines to make a designation referred to in Article 63, paragraph (3), item (i) pertaining to a pharmacy providing services covered by health insurance, the Minister must undergo discussion at the relevant local social insurance medical council.

A designation as referred to in Article 63, paragraph (3), item (i) expires when six years have elapsed after the day of designation.

With regard to a medical institution providing services covered by health insurance (excluding hospitals and clinics referred to in Article 65, paragraph (2)) or a pharmacy providing services covered by health insurance that are specified by Order of the Ministry of Health, Labour and Welfare, unless otherwise notified during the period from since six months before the expiration date of the designation pursuant to the provisions of the preceding paragraph until three months before that date, the application under Article 65, paragraph (1) is deemed to have been made.

If the establisher or administrator of a clinic has received a request from the prefectural governor pursuant to the provisions of Article 30-18-6, paragraph (6) of the Medical Care Act but did not comply with it, has received a recommendation from the prefectural governor pursuant to the provisions of paragraph (9) of that Article, or has received that recommendation but did not comply with it, the Minister of Health, Labour and Welfare may, notwithstanding the provisions of paragraph (1) of the preceding Article and pursuant to Order of the Ministry of Health, Labour and Welfare, attach a time limit of three years or less when making the designation referred to in Article 63, paragraph (3), item (i).

With regard to a designation referred to in Article 63, paragraph (3), item (i) to which a time limit has been attached pursuant to the provisions of the preceding paragraph, the provisions of paragraph (2) of the preceding Article do not apply.

In the case where a clinic or pharmacy has been established by a physician, dentist or pharmacist, and only the establisher (excluding a person who received a request from the prefectural governor under Article 30-18-6, paragraph (6) of the Medical Care Act but did not comply with it) who is that physician, dentist or pharmacist is engaged in medical care or prescription, if a registration under Article 64 has been made with respect to the physician, dentist or pharmacist, it is deemed that a designation referred to in Article 63, paragraph (3), item (i) has been made with regard to the clinic or pharmacy; provided, however, this does not apply when the clinic or pharmacy meets the requirements prescribed in Article 65, paragraph (3) or (4) but the Minister of Health, Labour and Welfare finds it inappropriate to deem that the designation referred to in Article 63, paragraph (3), item (i) has been made.

A medical institution providing services covered by health insurance or a pharmacy providing services covered by health insurance must put physicians providing health insurance treatment who are engaging in medical care at the institution or pharmacists filling health insurance prescriptions who are engaging in prescription at the pharmacy in charge of medical care or prescription pursuant to Order of the Ministry of Health, Labour and Welfare referred to in Article 72, paragraph (1) and must be responsible for benefits for medical treatment pursuant to Order of the Ministry of Health, Labour and Welfare.

Beyond the provisions of the preceding paragraph (including when applied mutatis mutandis to Article 85, paragraph (9), Article 85-2, paragraph (5), Article 86, paragraph (5), Article 110, paragraph (7), and Article 149), a medical institution providing services covered by health insurance or a pharmacy providing services covered by health insurance is responsible for benefits for medical treatment pursuant to the provisions of the Mariners Insurance Act, National Health Insurance Act, National Public Officers Mutual Aid Association Act (Act No. 128 of 1958; including when this is applied mutatis mutandis to other laws and the same rule governs), or Local Public Officers, etc. Mutual Aid Association Act (hereinafter referred to as "medical insurance laws other than this act") as well as medical treatment for insured persons and dependents, benefits for medical treatment pursuant to the provisions of the Act on Assurance of Medical Care for Elderly People, and treatment pertaining to dietary treatment expenses for inpatients, living support expenses for inpatients, and medical expenses combined with treatment outside insurance coverage.

A medical institution providing services covered by health insurance which is an advanced treatment hospital prescribed by Article 4-2 of the Medical Care Act or otherwise specified by Order of the Ministry of Health, Labour and Welfare is to take measures specified by Order of the Ministry of Health, Labour and Welfare as measures for sharing functions and for operational cooperation between medical institutions providing services covered by health insurance, for instance, by referring patients to medical institutions providing services covered by health insurance appropriate for the patients' symptoms or other circumstances.

A medical institution providing services covered by health insurance or a pharmacy providing services covered by health insurance is to cooperate with measures taken by the national government or a local government for the provision of the medical care listed in the items of Article 37, paragraph (1) of that Act and other necessary medical care concerning pandemic influenza or similar infectious disease prescribed in Article 6, paragraph (7) of the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases and other infectious diseases.

In order to improve the quality of medical care received by citizens and ensure its appropriate and efficient provision, a medical institution providing services covered by health insurance is to endeavor to take measures for streamlining its operations and improving the working environment of its employees.