A total of 12 articles are promulgated on November 1, 2012 in accordance with Bureau of National Health Insurance Order Wei-Shu-Chien-Pao No. 1012660242

 

Article 1

These regulations are duly enacted according to Paragraph 4 of Article 41 of the National Health Insurance Act (hereinafter referred to as the “Act”).

 

Article 2

The Insurer shall hold the “National Health Insurance Drug Dispensing Items and Fee Schedule Joint Establishment Meeting” (hereinafter referred to as the “Meeting”) at least once every two months in its formulation of drug dispensing items and fee schedule, and may hold special Meetings if necessary.

 

Article 3

The following issues shall be discussed in the Meeting before being determined by the insurer:

1.         The principle governing the inclusion of the National Health Insurance drugs;

2.         The principle governing the establishment of the fee schedule of the National Health Insurance drugs;

3.         The reimbursement items of new drugs and specialty materials of new functional category of the National Health Insurance;

4.         The fee schedule of new drugs and specialty materials of new functional category of the National Health Insurance; and

5.         Any other matter in relation to the National Health Insurance drug dispensing items and fee schedule.

The insurer shall submit reports on the results in the Meeting after it undertakes the following matters:

1.         The status of preliminary review in relation to the National Health Insurance drug dispensing items and fee schedule of new drug items and specialty materials of the current functional category. 

The status of preliminary review in relation to the change to the fee schedule of drugs which are reimbursed by the National Health Insurance.  

 

Article 4

Where the Meeting is convened, the following representatives shall be invited to attend the Meeting: 

1.         One representative each from the competent authority and its subordinate drug management agency;

2.         Five experts;

3.         Three representatives who represent the insured;

4.         Three representatives who represent employers;

5.         Representatives of the contracted medical care institutions as follows:

(1) One representative from each of the Taiwan Medical Association, the National Union of Chinese Medicine Doctors’ Association R.O.C.; the Taiwan Dental Association and the Taiwan Pharmacist Association;

(2) One representative from the Taiwan Hospital Association; and

(3) Two representatives each from medical centers, regional hospitals, community hospitals and primary care clinics.

The representatives set forth in the preceding paragraph shall be selected according to the following methods:

1.         Representatives of agencies: appointed by the agencies;

2.         Experts: selected by the insurer;

3.         Representatives of the insured and employers: selected by the insurer from the list of candidates recommended by the relevant organizations upon the request of the insurer; and

4.         Representatives of the contracted medical care institutions: recommended and appointed by the relevant organizations.

Drug suppliers may appoint three persons to attend the Meeting through the recommendation of the related organizations to express their opinions without the right to vote.

 

Article 5

The insurer shall appoint its senior manager or a member from the representatives of experts to act as the chairperson of the Meeting. 

 

Article 6

All representatives of the Meeting are without remuneration. The term of the representatives shall be two years which may be renewed after the expiration of the term. A representative who represents an agency or organization shall take up or quit the position of representative in concert with his or her position with the agency or organization that he or she represents. 

Where a representative of the Meeting is in serious violation of these regulations, the insurer may substitute such representative according to the resolution adopted by the Meeting. The insurer shall fill the vacancy according to Article 4. 

 

Article 7

Where the Meeting discusses whether a particular drug should be reimbursed or the reimbursement of such drug should be changed according to Paragraph 2 of Article 41 of the Act, the drug supplier of the drug in question, related experts and representatives of patient groups may be invited to attend the Meeting to state opinions.

 

Article 8

Where representatives of the Meeting fail to reach a consensus on an agenda item of the Meeting, the insurer shall submit the opinions expressed by representatives from different interest groups, analysis on the strengths and weaknesses of different proposals and the financial analyses thereof to the competent authority when it applies for the approval from the competent authority.

 

Article 9

Representatives of the Meeting shall fill out a declaration of conflict of interest before the first Meeting is held to declare that he or she, his or her spouse or linear relative has no business interest in whatever issue to be discussed in the Meeting. 

 

Article 10

If a representative of the Meeting has any of the following circumstances, he or she shall take initiative to recuse himself or herself from the discussion of the agenda item, and fill out and submit a declaration of recusal of the case to the insurer before the Meeting is held:

1.         He or she has any of the circumstances set forth in the paragraphs of Article 32 of the Administrative Procedure Act;

2.         He or she has any contact outside the procedure set forth in the preceding subparagraph and believes that such contact is sufficient to affect the discussion of the agenda item; or

He or she has any special cause which is not stipulated in the preceding two subparagraphs and believes that such cause is sufficient to affect the discussion of the agenda item. 

 

Article 11

The insurer shall make public the following items when discharging its duties under these regulations:

1.         Declarations of conflict of interest;

2.         Meeting agendas and the accompanying reports on medical technology evaluation; and

3.         Minutes of the Meeting.

The items set forth in Subparagraph 2 of the preceding paragraph shall be made public and delivered to representatives of the Meeting seven days prior to the Meeting.

 

Article 12

These regulations shall come into force on January 1, 2013.