Hà Nội, ngày 17 tháng 11 năm 2014

CIRCULAR

PROMULGATION AND GUIDELINES FOR LIST OF MODERN MEDICINES COVERED BY HEALTH INSURANCE

Pursuant to the Law on Health insurance No. 25/2008/QH12 dated November 14, 2008 and the Law No. 46/2014/QH13 dated June 13, 2014 on amendments to the Law on Health insurance;

Pursuant to the Government's Decree No. 63/2012/NĐ-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government's Decree No. 105/2014/NĐ-CP dated November 15, 2014 on guidelines for the Law on Health insurance;

The Minister of Health promulgates a Circular on promulgation and guidelines for List of modern medicines covered by health insurance.

Article 1. List of modern medicines

1. A List of modern medicines covered by health insurance is promulgated together with this Circular, which consists of: 845 active ingredients, 1064 modern medicines; 57 radiopharmaceuticals and tracers.

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Article 2. Structure of the List of modern medicines and classes of hospitals

1. List of modern medicines

a) The medicines or active ingredients are divided into 27 large groups according to ATC (anatomical, therapeutic, chemical) classification system Some medicines or active ingredients having more than one ATC codes or indications shall be put into the most suitable group to avoid repetition;

b) Names of medicines and active ingredients shall be international nonproprietary names and the names in National Pharmacopoeia Vietnam’s; only administration routes and dosage forms shall be written; content shall be omitted.

2. Administration routes of medicines on the List shall be written as follows:

a) Orally administered medicines include: tablets to swallow, chew, lozenges, sublingual tablets;

b) Injection includes intramuscular injection, subcutaneous injection, intradermal injection, intravenous injection, intravenous infusion, intra-articular injection, intravitreal injection, intraperitoneal injection;

c) Topically administered medicines include topical cream, transdermal patches, transdermal spray;

d) Suppositories include vaginal suppositories, rectal suppositories, and enema;

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e) Ocular medications include eye drops and eye ointment

3. Each class of hospitals is permitted to use certain medicines and active ingredients on the list of modern medicines as follows:

a) Special-class and Class I hospitals shall use medicines in column 5;

b) Class II hospitals shall use medicines in column 6;

c) Class III and Class IV hospitals, including general clinics of general hospitals or medical centers of districts/provincial cities shall use medicines in column 7;

d) Medical stations of communes, wards and towns and equivalent administrative divisions shall use medicines in column 8;

dd) Any unclassified medical facility that signs contracts for medical services covered by health insurance: Depending on the professional capability, medical equipment, and the list of medical techniques approved by a competent authority, the Service of Health shall take charge and cooperate with a social insurance organization in deciding the medicines may be used by such medical facility similarly to state-owned medical facilities.

4. The names of radiopharmaceuticals and tracers shall be international nonproprietary names. Radiopharmaceuticals and tracers may only be used at nuclear medicine facilities, oncology hospitals, oncology facilities, nuclear medicine wards, oncology or radiotherapy wards of general hospitals or specialized hospitals.

Article 3. Compilation of the List of modern medicines covered by health insurance used as medical facilities

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2. The purchase and use of the following medicines shall be preferred: generic medicines, single-substance medicines, locally manufactured medicines

Article 4. Rules for covering medicine costs incurred by patients having health insurance cards

1. Health insurance fund shall pay for medicine costs according to the use quantity and buying prices of the medical facility in accordance with regulations of law on medicines bidding in order to ensure the benefits of patients prescribed by the Law on Health insurance, the Law on amendments to the Law on Health insurance and their guiding documents.

2. Medicine costs shall not be covered by health insurance fund in the following cases:

a) Medicine costs are included in prices for medical techniques or daily inpatient charge (e.g. general anesthetics, local anesthetics, intravenous fluids used during operations, medical procedures, or radiocontrast media used for medical imaging; disinfectants and antiseptics), or all-inclusive charge for a patient according to applicable regulations;

b) The medicines are on the list of medicines covered by government budget;

c) The medicines are on the list of medicines used for clinical testing or scientific research;

d) A competent authority has issued a decision on recall of the batch of medicines;

dd) Medicines are not used in accordance with indications in the application for medicine registration which is granted.

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1. Isomers or other salts of the active ingredients shall be covered by health insurance if their therapeutic effects are the same with the chemical forms or medicines on the list.

2. Medicines in one group used for treatment of diseases in another group shall be covered by health insurance if their indications are consistent with those in the application for medicine registration which is granted.

3. Some medicines of which payment conditions and insurance coverage ratio are specified in column 9 of the list of modern medicines according to the rules in Clause 1 Article 4 of this Circular.

4. Any medicine that contains multiple active ingredients (hereinafter referred to as combined medicines) that are not enumerated on the list shall be covered by health insurance if it exist in the element form (except for vitamins and minerals) and has the same administration route as prescribed in Clause 2 Article 2 of this Circular.  Combined medicines chosen must ensure safety, effectiveness, and suit the capacity of health insurance fund.

If a medicine contains multiple active ingredients sorted into different classes of hospital, they shall be paid for according to the highest class. If a medicine contains multiple active ingredients with different insurance coverage ratios, the lowest coverage ratio shall apply.

5. If the patient only uses the amount of medicine in the smallest package unit according to indications (e.g. pediatrics or oncology medicines) and the residual amount cannot be used (e.g. there are not patients with the same indications, the residual amount is not sufficient to make a dose, the medicine is expired), the price of the smallest package unit shall be covered by health insurance.

6. Any medicine marked with an asterisk (*) shall only be used when other medicines in the group are not effective and a medical consultation must be held before use. If such medicine is used for emergency treatment, the medical consultation must be held within the next working day on the latest.

7. Antineoplastic medicines:

a) Antineoplastic medicines may only be used for cancer treatment at medical facilities licensed to treat cancer (including oncology facilities, blood transfusion facilities, and nuclear medicine facilities; oncology wards, hematology and blood fusion wards, and nuclear medicine wards of general hospitals or specialized hospitals) and must be prescribed by licensed physicians specialized in oncology or hematology;

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Such medicines shall be covered by health insurance according to the guidance on diagnosis and treatment of the Ministry of Health or the hospital. If guidance on diagnosis and treatment is not available, a medical consultation with physicians specialized in oncology must be held. If guidance on diagnosis and treatment and physicians specialized in oncology are not available, a medical consultation chaired by the head of the hospital must be held before use (except for the medicines exempt from medical consultation with oncology ward in column 9).

8. If the medical facility provides medical techniques of superior hospitals, it may use the medicines on the list of medicines for the superior hospital which suit the medical techniques approved by a competent authority. Each medical facility shall compile and send a list of to the health insurance authority as the basis for payment.

9. Any medicines prepared by the medical facility itself shall be covered by health insurance if they are used at that same medical facility. The medicine prices shall be determined according to the product prices decided by the Director of the hospital after reaching an agreement with the social insurance authority. The Director of the hospital shall bear the legal responsibility for such prices.

Article 6. Implementation

1. The Ministry of Health has responsibilities to:

a) Provide instructions and carry out inspection of medicine list compilation, bidding for medicines supply, management, use of medicines, payment for medicines by medical facilities;

b) Take charge and cooperate with relevant agencies in resolving difficulties during the implementation;

c) Take charge and cooperate with relevant agencies in updating, adjusting the list of medicines promulgated together with this Circular every 02 years to meet treatment demands and suit the capacity of health insurance fund.

2. Social Insurance Office has the responsibilities to:

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b) Cooperate with relevant agencies in resolving difficulties during the implementation.

3. Services of Health have responsibilities to:

a) Compile lists of medicines, provide instructions and carry out inspection of medicine list compilation, bidding for medicines supply, management, use of medicines, payment for medicines by medical facilities within the scope of their competence;

b) Provide instructions and consider approving the lists of medicines used at local medical clinics without physicians and medical stations of communes, wards and towns.

4. Medical facilities have responsibilities to:

a) Compile lists of medicines they use, including those used for provision of medical techniques of superior hospitals and medicines prepared by the medical facilities themselves;

b) Provide medicines adequately, promptly, and properly to meet treatment demands of patients having health insurance according to the list of medicines compiled. Do not let insured patients buy such medicines at their own expense.  Medical facilities shall send social insurance authorities the results of medicine bidding; lists of commercial medicines used at medical facilities, including: medicines to be purchased, medicines for provision of medical techniques of superior hospitals, and medicines prepared by the medical facilities themselves. These are the basis for social insurance authorities to make payments;

c) Manage the prescription of medicines, ensure safety, rationality, thriftiness; ensure quality of medicines used therein; hold medical consultations when using medicines marked with an asterisk (*); make payments in a timely manners with correct categories, quantities, and prices;

dd) Comply with current regulations on management and use of medicines; comply with regulations of law on radiation safety an control with regard to management, supply, use of radiopharmaceuticals and tracer on the list of medicines;

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e) If the list of medicines that need adjusting, the medical facility shall submit an application using the form in Appendix 02 hereof to the Ministry of Health (Health Insurance Administration) or the Service of Health.

Article 7. Transition and terms of reference

1. If an insured patient is admitted before the effective date of this Circular but still undergoing treatment at the medical facility, regulations of Circular No. 31/2011/TT-BYT dated July 11, 2011 and Circular No. 10/2012/TT-BYT dated June 08, 2012 shall apply until the patient discharged.

2. If any medicines on the list promulgated together with Circular No. 31/2011/TT-BYT dated July 11, 2011 and Circular No. 10/2012/TT-BYT dated June 08, 2012 are not on the list of medicines covered by health insurance promulgated together with this Circular, they shall be paid for by health insurance until the medicines supplied by the successful bidder are used up according to the medicine bidding result and the contract between the medical facility and the supplier signed before the effective date of this Circular.

3. With regard to any medicines on the list promulgated together with Circular No. 31/2011/TT-BYT dated July 11, 2011, the payment conditions and coverage ratios of which are specified in this Circular, health insurance fund shall make payments according to the payment conditions and coverage ratios prescribed in this Circular from January 01, 2015, except for the case in Clause 1 of this Article).

Article 8. Effect

1. This Circular takes effect on January 01, 2015.

2. Circular No. 31/2011/TT-BYT dated July 11, 2011 on promulgation of the List of essential medicines at medical facilities covered by health insurance and Circular No. 10/2012/TT-BYT dated June 08, 2012 on amendments to Circular No. 31/2011/TT-BYT are annulled from the effective dated of this Circular.

All units are recommended to report the difficulties that arise during the implementation of this Circular to the Ministry of Health for consideration./.

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PP MINISTER
DEPUTY MINISTER




Nguyen Thi Xuyen

Thông tư 40/2014/TT-BYT hướng dẫn thực hiện danh mục thuốc tân dược thuộc phạm vi thanh toán của quỹ bảo hiểm y tế do Bộ trưởng Bộ Y tế ban hành