On promulgation of list of oriental medicines, herbal medicines and traditional ingredients covered by health insurance



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THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness  
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No. 05/2015/TT-BYT

Hanoi, March 17, 2015

 

CIRCULAR

ON PROMULGATION OF LIST OF ORIENTAL MEDICINES, HERBAL MEDICINES AND TRADITIONAL INGREDIENTS COVERED BY HEALTH INSURANCE

Pursuant to the Law on Health insurance;

Pursuant to the Law on Pharmacy;

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

Pursuant to the Decree No. 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;

The Minister of Health issues a Circular on promulgation of List of oriental medicines, herbal medicines and traditional ingredients covered by health insurance.

Article 1. List of oriental medicines, herbal medicines and traditional ingredients

1. Issuing the List of oriental medicines, herbal medicines and traditional ingredients covered by health insurance, including:

a) List of oriental medicines and herbal medicines;

b) List of traditional ingredients.

2. The List of oriental medicines and herbal medicines (hereinafter referred to as List of medicines) and the List of traditional ingredients (hereinafter referred to as List of ingredients) issued together with this Circular is the basis for health insurance fund to cover the cost of medicines or ingredients incurred by patients having health insurance cards at the health facilities.

Article 2. Structure of Lists of medicines or ingredients

1. The List of medicines is divided into 11 groups according to medical theory of traditional medicine and 5 columns as follows:

a) Column 1: ordinal numbers of medicines in the List;

b) Column 2: ordinal numbers of medicines in each group;

c) Column 3: full names of herbal ingredients; the ingredients with “/” symbol are interchangeable; the ingredients with “()” are adjustable;

d) Column 4: administration routes, in particular, orally administered medicines include: tablets to swallow, chew, lozenges, sublingual tablets; topically administered medicines include topical cream, transdermal patches, transdermal spray, soak, steam.

dd) Column 5: precautions for indication and health facilities entitled to use those medicines.

2. The List of ingredients including 349 ingredients from medicinal plants, animals or minerals shall be divided into 30 groups according to medical theory of traditional medicine and 6 columns as follows:

a) Column 1: ordinal numbers of ingredients in the List;

b) Column 2: ordinal numbers of ingredients in each group;

c) Column 3: names of ingredients;

d) Column 4: origins of ingredients, “B” symbol for ingredients originated from foreign countries; "N" symbol for ingredients originated locally;

dd) Column 5: scientific names of ingredients;

e) Column 6: scientific names of medicinal plants, animals or minerals.

Article 3. Guidelines for List of medicines and List of ingredients

1. The List of medicines:

a) The medicines included in the list of medicines which are used in health facilities must comply with regulations on prescription medicine and conform to professional competence of health facilities;

b) The medicines having ingredients and/or administration routes mentioned in the List, including medicines having interchangeable or adjustable ingredients shall be covered by health insurance;

Example:

(1) The medicines No. 3 in the column 1 of the List of medicines which have following ingredients (scientific names): Radix Bupleuri, Radix Peucedani, Rhizoma Ligustici wallichii, Fructus Aurantii, Rhizoma et radix Notopterygii, Radix Angelicae pubescentis, Poria, Radix Platycodi grandiflori, Radix Ginseng/Radix Codonopsis, Radix Glycyrrhizae. Health insurance shall cover the medicines having following ingredients:

+ Radix Bupleuri, Radix Peucedani, Rhizoma Ligustici wallichii, Fructus Aurantii, Rhizoma et radix Notopterygii, Radix Angelicae pubescentis, Poria, Radix Platycodi grandiflori, Radix Ginseng, Radix Glycyrrhizae;

+ Radix Bupleuri, Radix Peucedani, Rhizoma Ligustici wallichii, Fructus Aurantii, Rhizoma et radix Notopterygii, Radix Angelicae pubescentis, Poria, Radix Platycodi grandiflori, Radix Codonopsis, Radix Glycyrrhizae;

+ Radix Bupleuri, Radix Peucedani, Rhizoma Ligustici wallichii, Fructus Aurantii, Rhizoma et radix Notopterygii, Radix Angelicae pubescentis, Poria, Radix Platycodi grandiflori, Radix Ginseng, Radix Glycyrrhizae;

+ Radix Bupleuri, Radix Peucedani, Rhizoma Ligustici wallichii, Fructus Aurantii, Rhizoma et radix Notopterygii, Radix Angelicae pubescentis, Poria, Radix Platycodi grandiflori, Radix Codonopsis, Radix Glycyrrhizae.

(2) The medicines No. 45 in the column 1 of the List of medicines which have following ingredients: Herba Adenosmatis caerulei, Rhizoma Alismatis, Rhizoma Rhei, Radix Rehmanniae glutinosae, Radix Angelicae sinensis, Radix Ophiopogonis japonica, Radix Gentianae, Fructus Gardeniae, Radix Scutellariae, (Radix Glycyrrhizae), (Caulis Clematidis). Health insurance shall cover the medicines having following ingredients:

+ Herba Adenosmatis caerulei, Rhizoma Alismatis, Rhizoma Rhei, Radix Rehmanniae glutinosae, Radix Angelicae sinensis, Radix Ophiopogonis japonica, Radix Gentianae, Fructus Gardeniae, Radix Scutellariae;

+ Herba Adenosmatis caerulei, Rhizoma Alismatis, Rhizoma Rhei, Radix Rehmanniae glutinosae, Radix Angelicae sinensis, Radix Ophiopogonis japonica, Radix Gentianae, Fructus Gardeniae, Radix Scutellariae, Radix Glycyrrhizae;

+ Herba Adenosmatis caerulei, Rhizoma Alismatis, Rhizoma Rhei, Radix Rehmanniae glutinosae, Radix Angelicae sinensis, Radix Ophiopogonis japonica, Radix Gentianae, Fructus Gardeniae, Caulis Clematidis;

+ Herba Adenosmatis caerulei, Rhizoma Alismatis, Rhizoma Rhei, Radix Rehmanniae glutinosae, Radix Angelicae sinensis, Radix Ophiopogonis japonica, Radix Gentianae, Fructus Gardeniae, Radix Scutellariae, Radix Glycyrrhizae, Caulis Clematidis.

(3) The medicines No. 108 in the column 1 of the List of medicines having following ingredients: Radix Ginseng/Radix Codonopsis, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, (Rhizoma Zingiberis recens), (Fructus Ziziphi jujubae). Health insurance shall cover the medicines having following ingredients:

+ Radix Ginseng, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae;

+ Radix Ginseng, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, Rhizoma Zingiberis recens;

+ Radix Ginseng, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, Fructus Ziziphi jujubae;

+ Radix Ginseng, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, Rhizoma Zingiberis recens, Fructus Ziziphi jujubae;

+ Radix Codonopsis, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae;

+ Radix Codonopsis, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, Rhizoma Zingiberis recens;

+ Radix Codonopsis, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, Fructus Ziziphi jujubae;

+ Radix Codonopsis, Radix Astragali, Radix Angelicae sinensis, Rhizoma Atractylodes macrocephalae, Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri reticulatae perenne, Radix Glycyrrhizae, Rhizoma Zingiberis recens, Fructus Ziziphi jujubae.

c) The medicines whose ingredients are specified according to herbal ingredient names. These medicines shall be covered by health insurance if they have herbal ingredients mentioned in the List of medicines, including different extract forms, dosages of herbal ingredients;

d) If the medicines in a group are used for treatment of diseases in another group, they shall be covered by health insurance if their indication conforms to the application for drug registration approved by the Ministry of Health.

2. The List of ingredients:

a) The ingredients included in the List of ingredients which are used in health facilities must comply with regulations on prescription drugs and conform to professional competence in prescriptions of traditional doctors, traditional physicians or herbalists working in the health facilities;

b) Ingredients with “B” symbol in column 4 in the list shall be covered by health insurance if they are originated locally or from foreign countries;

c) Ganoderma ingredients originated from foreign countries, Radix Ginseng and Radix Notoginseng or herbal remedies which combine these 2 or 3 ingredients must be subject to medical consultation before use. The medical consultation forms shall comply with regulations of the Ministry of Health.

Article 4. Compilation of the List of medicines and the List of ingredients used in health facilities and self-prepared medicines of health facilities which are covered by health insurance

1. According to the List of medicines and the List of ingredients issued together with this Circular, disease model and professional competence, each health facility shall compile a list of medicines, ingredients and self-prepared medicines (if any) it uses in accordance with regulations of law on bidding, satisfy treatment demands and use as basis for payment made by health insurance fund.

2. The following medicines in the List of medicines and ingredients issued together with this Circular shall be preferred: locally manufactured medicines; medicines of pharmacy enterprises meeting Good manufacturing practices (GMP); locally originated ingredients; medicines or ingredients having effective treatment and reasonable costs.

3. According to purchase of specific medicines or ingredients, the health facility shall send the List of medicines and ingredients used in the health facility and their self-prepared medicines to social insurance authorities as a basis for payment.

Article 5. Covering costs of medicines, ingredients; herbal remedies used in health facilities and self-prepared medicines of heath facilities

1. General rules: Health insurance fund shall pay for costs of medicines, ingredients and self-prepared medicines of health facilities according to the use quantity and buying prices of the health 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 and their guiding documents.

2. For ingredients: Health insurance fund shall pay according to prices of herbal ingredients which health facilities buy in accordance with regulations of law on medicines bidding plus (+) damage cost prescribed in regulations of the Ministry of Health (if any).

3. For oriental medicines whose ingredients specified in the List of ingredients issued together with this Circular: Health insurance fund shall pay the following costs: costs of ingredients following rules prescribed in Clause 2 of this Article, packaging cost, decoction cost, including electricity, water, fuel. Heath facilities are covered by packaging cost and decoction cost if the medicines or ingredients are decocted at the health facilities.

4. For self-prepared medicines of health facilities:

a) The ingredients in the self-prepared medicines must be specified in the List of traditional ingredients issued together with this Circular;

b) Health insurance fund covering according to prime costs of medicines, including: costs of medicinal materials, damage cost as prescribed by the Ministry of Health, packaging costs, preparation costs including electricity, water, fuel and other costs including excipients, medicinal additives, testing costs (packaging, materials, semi-finished and finished products);

c) The head of each heath facility shall approve manufacturing process, quality standards and prices of their self-prepared medicines then concur with the social insurance authority in use of them as the basis for payment.

5. For ingredients, oriental medicines and self-prepared medicines of health facilities: If those costs prescribed in Clause 2, Clause 3 and Clause 4 of this Article incur, the heath facility shall prepare a detailed presentation to concur with the social insurance authority in use of them as the basis for payment. If the health facility fails to concur with the social insurance authority, it shall send a report to the Ministry of Health in case it is affiliated to Ministries or agencies or it shall send a report to Services of Health in case it is affiliated to Services of Health for consideration.

6. Health insurance fund shall not pay for medicines or ingredients covered by government budget.

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 or ingredients promulgated together with this Circular to meet treatment demands and suit the capacity of health insurance fund.

2. Social Insurance Office has responsibilities to:

a) Instruct social insurance authorities of provinces to cooperate with Services of Health and health facilities in paying for medicine costs in accordance with this Circular and relevant legislative documents;

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

3. Services of Health of provinces have responsibilities to:

a) Provide instructions for health facilities in administrative divisions to compile lists of medicines, ingredients or self-prepared medicines; bidding for medicines supply and payment for medicines by medical facilities within the scope of their competence;



b) Carry out inspection and promptly handle irregularities and difficulties in bidding, supply, prescription and use of medicines in treatment for patients.

4. Health facilities have responsibilities to:

a) Compile lists of medicines or ingredients used in health facilities or self-prepared medicines, then send them to social insurance authorities for payment according to the form in Appendix 1 issued together with this Circular.

If the list of medicines needs adjusting, the heath facility has responsibility to compile an adjusted list of medicines as prescribed in Clause 3 of Article 4;

b) Manage, supply and use medicines as prescribed in regulations of law in force, ensure supplying medicines sufficiently, promptly, in accordance with regulations of law, meeting treatment demands of patients having health insurance cards according to the compiled list, avoiding patients buying medicines themselves. The bidding for medicine supply shall comply with regulations of law on medicine bidding;

c) Comply regulations on prescription of medicines, ensure safety, rationality, thriftiness; ensure quality of medicines used therein; hold medical consultation when using medicines prescribed in Point c Clause 2 of Article 3;

d) If the list of medicines needs adjusting, the health facility shall submit an application using the form in Appendix 2 and Appendix 3 hereof to the Ministry of Health or the Services of Health of provinces.

5. Social insurance authorities of provinces have responsibilities to:

a) Cooperate with health facilities in compilation of lists of medicines, ingredients or self-prepared medicines covered by Health insurance fund;

b) Cooperate with health facilities in paying for medicine costs as prescribed in Article 5 of this Circular.

Article 7. Transitional provisions and terms of reference

1. If an insured patient is admitted before the effective date of this Circular but still undergoing treatment at the health facility from May 1, 2015, regulations of Circular No. 12/2010/TT-BYT dated April 29, 2010 shall apply until the patient discharged.

2. With regard to any medicines or ingredients covered by health insurance promulgated together with the Circular No. 12/2010/TT-BYT dated April 29, 2010, 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 health facility and the supplier signed before the effective date of this Circular.



3. With regard to any medicines covered by health insurance prescribed in Circular No. 31/2011/TT-BYT dated July 11, 2011, subject to quota on indication specified in this Circular, health insurance fund shall make payments according to regulations of this Circular from May 01, 2015, except for the case in Clause 1 of this Article.

4. With regard to ingredients or oriental medicines used in health facilities and self-prepared medicines of the health facilities, health insurance fund shall make payments as prescribed in Article 5 hereof from the effective date of this Circular.

Article 8. Effect

1. This Circular takes effect from May 01, 2015.

2. Circular No. 12/2010/TT-BYT dated April 29, 2010 of the Minister of Health on promulgation of the List of essential traditional medicines at health facilities is annulled from the effective date of this Circular.

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

 

 

PP.MINISTER
DEPUTY MINISTER
Nguyen Thi Xuyen

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