Circular No. 30/2018/TT-BYT dated October 30, 2018 of the Ministry of Health on promulgation of list of modern medicines, biologicals, radiopharmaceuticals and tracers covered by health insurance, insurance coverage ratio and payment conditions thereof

THE MINISTRY OF HEALTH

CircularNo. 30/2018/TT-BYT dated October 30, 2018 of the Ministry of Health on promulgation of list of modern medicines, biologicals, radiopharmaceuticals and tracers covered by health insurance, insurance coverage ratio and payment conditions thereof

Pursuant to the Law on health insurance dated November 14, 2008, as amended and supplemented by the Law on health insurance dated June 13, 2014;

Pursuant to the Government’s Decree No. 105/2014/ND-CP dated November 15, 2014 providing guidelines for implementation of the Law on health insurance;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Health Insurance Department;

Minister of Health promulgates a Circular promulgating the List of modern medicines, biologicals, radiopharmaceuticals and tracers covered by health insurance, insurance coverage ratio and payment conditions thereof.

Article 1. Lists enclosed with this Circular

1. The list of modern medicines and biologicals covered by health insurance is provided in the Appendix 01 enclosed with this Circular (hereinafter referred to as the “Appendix 01”).

2. The list of radiopharmaceuticals and tracers covered by health insurance is provided in the Appendix 02 enclosed with this Circular (hereinafter referred to as the “Appendix 02”).

Article 2. Structure of Lists and classes of hospitals

1. Modern medicines and biologicals on the list provided in the Appendix 01 are divided into 27 large groups according to their therapeutic effects and the list includes 8 columns as follows:

a) Column 1: Ordinal number of the listed medicine;

b) Column 2: Name of the listed medicine. Names of medicines shall be International Nonproprietary Names (INN) of their active ingredients. In case the INN is not available, the name of the active ingredient licensed to be sold shall be specified. Listed medicines are divided into 27 large groups according to ATC (anatomical, therapeutic, chemical) classification system; 

c) Column 3: Administration routes; concentrations and dosages forms are not required, except some dosage forms with different therapeutic effects. Administration routes of medicines on the List provided in the Appendix 01 shall be written as follows:

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

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

- Topically administered medicines include topical cream, transdermal patches, transdermal spray, cleansing solutions;

- Rectal suppositories include vaginal suppositories, rectal suppositories, and enema;

- Medicines administered through the respiratory tract include nebulizers, inhaled medications (solutions, suspensions and dry-powder inhalers) and aerosol;

- Ocular medications include eye drops and eye ointment; ear infection medications include ear drops; nasally administered medicines include nose drops and nasal sprays;

- Administration routes of some medicines other than the above-mentioned ones shall be specified on the List;

d) Columns 4, 5, 6, 7: Classes of hospitals permitted to use the listed medicines. Each class of hospitals is permitted to use certain medicines and active ingredients on the list of modern medicines and biologicals provided in the Appendix 01 as follows:

- Special-class and Class I hospitals shall use medicines in column 4;

- Class II hospitals shall use medicines in column 5;

- Class III and Class IV hospitals, including general clinics of general hospitals or medical centers of districts/provincial cities shall use medicines in column 6;

- Medical stations of communes, wards and towns, and equivalent administrative divisions, and healthcare units of regulatory authorities shall use medicines in column 7;

- Any unclassified health facility that signs contracts for provision of 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 Provincial Department of Health shall take charge and cooperate with the provincial social insurance office in deciding the medicines may be used by such health facility;

- Any unclassified state-owned health facility that is affiliated to the armed forces or police security forces and signs contracts for provision of 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 Provincial Department of Health shall take charge and cooperate with the governing authority of that health facility and the provincial social insurance office in deciding the medicines may be used by such health facility;

- Any private hospital that signs contracts for provision of medical services covered by health insurance but does not have its medical techniques classified for being granted a suitable class: Depending on the professional capability, medical equipment, and the list of medical techniques approved by a competent authority, the Provincial Department of Health shall take charge and cooperate with the provincial social insurance office in deciding the medicines may be used by such private hospital according to its level of medical techniques;

- Any private clinic that signs contracts for provision of medical services covered by health insurance but does not have its medical techniques classified: Depending on the professional capability, medical equipment, and the list of medical techniques approved by a competent authority, the Provincial Department of Health shall take charge and cooperate with the provincial social insurance office in deciding the medicines may be used by such private clinic, which may be similar to those for a hospital of Class III or lower;

- If a health facility is capable of providing 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 health facility shall compile and send a list of to the relevant social insurance authority as the basis for payment.

- If a provincial specialized health facility uses medicines which are not accompanied with medical services, based on the professional capability, medical equipment, treatment demand of the health facility, and the guidance on diagnosis and treatment of the Ministry of Health, the Provincial Department of Health shall take charge and cooperate with the provincial social insurance office in deciding the medicines may be used by such health facility, which may be similar to those for a general hospital of province or lower class;

dd) Column 8: Payment conditions, coverage ratio and specific notes for some medicines.

2. The list of radiopharmaceuticals and tracers provided in the Appendix 02 includes 5 columns as follows:

a) Column 1: Ordinal number of the listed medicine;

b) Column 2: Name of the listed medicine. Names of listed medicines shall be International Nonproprietary Names (INN). In case the INN is not available, the name of the active ingredient licensed to be sold shall be specified;

c) Column 3: Administration routes;

d) Column 4: Dosage forms of medicines;

dd) Column 5: Measurement units of medicines.

Radiopharmaceuticals and tracers on the List provided in the Appendix 02 are not provided according to classes of hospitals and are only used by health facilities permitted by competent authorities to use radioactive substances in diagnosis and treatment of diseases.

Article 3.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 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 its guiding documents.

2. Health insurance fund shall pay for medicine costs in case indications for using a medicine must be conformable with indications in the package insert of that medicine licensed for sale by the Ministry of Health or the guidance on diagnosis and treatment of the Ministry of Health. If the use of a medicine is conformable with neither the indications in its package insert nor the guidance on diagnosis and treatment of the Ministry of Health but is necessary for treatment of a given disease, the Ministry of Health shall establish a Council for considering each specific case.

3. Health insurance fund shall pay for medicines or batches of medicines recalled according to written guidance of the Ministry of Health.

4. Medicine costs shall not be covered by health insurance fund in the following circumstances:

a) Medicine costs are included in prices for medical techniques or medical examination costs or daily inpatient charges or all-inclusive charge for a patient according to applicable regulations;

b) Medicine costs are covered by state budget or other financing sources;

c) Medicine are used for clinical testing or scientific research.

Article 4. Payment for some medicines

1. Other isomers or salts of the active ingredients (whether in element or compound form, except for vitamins and minerals) on the List of medicines provided in the Appendix 01 shall be covered by health insurance fund if their indications 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 fund if their indications are consistent with Clause 2 Article 3 of this Circular.

3. Payment conditions and coverage ratio of some medicines are specified in column 8 of the List of medicines provided in the Appendix 01

4. If the patient only uses an 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. no patients have 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.

5. A medical consultation must be held before the use of any medicine marked with an asterisk (*), except emergency treatment. Antibiotics marked with an asterisk (*) shall be covered by health insurance fund if medical consultation procedures are followed when making prescriptions for such antibiotics according to theManual on management and use of antibiotics in hospitalsof the Ministry of Health.

6. Antineoplastic medicines:

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

b) If antineoplastic medicines are used for treatment of diseases other than cancer: 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 of such medicines.

7. Any medicines prepared by the health facility itself shall be covered by health insurance if: 

a) Their active ingredients are on the List provided in the Appendix 01;

b) Administration route, dosage form and class of hospital are consistent with the List provided in the Appendix 01;

c) They are used at the same health facility;

d) The head of that health facility shall consider giving approval for preparation or manufacturing process, quality standards and prices of such medicines; reach an agreement with the social insurance office on the medicine prices for use as the basis for payment. The product’s prime cost shall be decided by considering the following: the costs of ingredients; loss cost, packaging cost, labor cost, manufacturing costs, including costs of electricity, water and fuel, testing cost and other costs (if any).

Article 5. Implementation

1. The Health Insurance Department affiliated to the Ministry of Health shall:

a) Provide instructions and carry out inspection of management, use and payment for medicines covered by health insurance by health facilities;

b) Resolve difficulties that arise during the implementation;

c) Update and adjust the lists of medicines to meet treatment demands and suit the payment capacity of health insurance fund;

d) Take charge and cooperate with the Administration of Medical Examination and Treatment, the Drug Administration of Vietnam and relevant agencies in requesting the head of the Ministry of Health to establish the professional advisory council to consider and decide the payment for cases where a medicine is conformable with neither the indications in its package insert included in application for medicine registration granted license by the Ministry of Health nor the guidance on diagnosis and treatment of the Ministry of Health but is necessary for treatment of a given disease.

2. Vietnam Social Security Administration shall:

a) Instruct social insurance offices of provinces and central-affiliated cities to cooperate with Provincial Departments of Health and health facilities in paying for medicines in accordance with this Circular and relevant legislative documents;

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

3. Health agencies affiliated to the armed forces or the public security forces shall: Instruct health facilities affiliated to the armed forces or the public security forces under their management to cooperate with Provincial Departments of Health and social insurance offices in considering and deciding the use of medicines by such health facilities that are not classified and sign contracts for provision of medical services covered by health insurance according to Point d Clause 1 Article 2 of this Circular.

4. Departments of Health of provinces and central-affiliated cities shall:

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

b) Take charge and cooperate with relevant agencies in deciding the use of medicines by health facilities prescribed in Point d Clause 1 Article 2 of this Article.

5. Health facilities shall:

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

b) Provide medicines adequately, promptly, and properly to meet treatment demands of patients having health insurance cards according to the list of medicines compiled. Health facilities shall provide social insurance offices that enter into contracts for provision of medicines covered by health insurance with them with the lists of medicines used for provision of medical techniques of superior hospitals, and medicines prepared by the health facilities themselves. These are the basis for social insurance offices 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 (*) according to professional regulations; make payments in a timely manners with correct categories, quantities, and prices;

d) If the list of medicines needs adjusting, the relevant health facility shall compile an adjusted list of medicines and send it to the social insurance office for use as the basis for making payments;

dd) If the lists of medicines provided in this Circular need adjusting to meet actual conditions and treatment demands, the health facility shall submit applications to the Health Insurance Department affiliated to the Ministry of Health (if it is affiliated to the Ministry of Health) or the Provincial Department of Health (if it is affiliated to the Provincial Department of Health) for consolidating and submitting them to the Ministry of Health.

Article 6. Effect

1. This Circular takes effect on January 01, 2019.

2. The Circular No. 40/2014/TT-BYT dated November 17, 2014, the Circular No. 36/2015/TT-BYT dated October 29, 2015 and Article 4 of the Circular No. 50/2017/TT-BYT dated December 29, 2017 of the Ministry of Health are annulled from the effective date of this Circular.

Article 7. Transition

1. If an insured patient is admitted before January 01, 2019 but still undergoing treatment at the health facility, regulations of the Circular No. 40/2014/TT-BYT, the Circular No. 36/2015/TT-BYT and the Circular No. 50/2017/TT-BYT shall apply until that patient is discharged, including prescriptions given to that patient after discharge.

2. If any medicines or administration routes of medicines are covered by health insurance according to the Circular No. 40/2014/TT-BYT, the Circular No. 36/2015/TT-BYT or the Circular No. 50/2017/TT-BYT but are not covered by health insurance according to this Circular, or which classes of hospitals permitted to use are restricted according to this Circular, they shall be paid for by health insurance fund until the medicines supplied by the successful bidder are used up according to the medicine bidding result and the contract signed between the health facility and the supplier before January 01, 2019.

If a private health facility purchases medicines according to Article 52 of the Law on bidding: health insurance fund shall pay for medicines purchased before January 01, 2019 and used until March 31, 2019.

3. With regard to medicines covered by health insurance according to the Circular No. 40/2014/TT-BYT, the Circular No. 36/2015/TT-BYT or the Circular No. 50/2017/TT-BYT but the payment conditions or coverage ratios of which or which classes of hospitals are permitted to use are changed according to this Circular, health insurance fund shall make payments according to the payment conditions, coverage ratios and classes of hospitals prescribed in this Circular from January 01, 2019, except for the case in Clause 1 and Clause 4 of this Article.

4. If a cancer patient is treated with Doxorubicin (injection, liposomal form), or Erlotinib (oral administration), or Gefitinib (oral administration), or Sorafenib (oral administration, for treatment of advanced hepatocellular carcinoma and advanced renal cell carcinoma) before January 01, 2015 and still uses such medicines after January 01, 2019, 100% of medicine costs shall be covered by health insurance fund. If a cancer patient is treated with Everolimus (injection or oral administration), or L-asparaginase erwinia (injection), or Paclitaxel (injection, liposomal and polymeric micelle forms) before January 01, 2019 and is still treated with such medicines after January 01, 2019, or Sorafenib (oral administration, for treatment of advanced renal cell carcinoma) after January 01, 2015 and is still treated with this medicine after January 01, 2019, the costs of these medicines shall be paid for by health insurance fund according to the coverage ratios prescribed in the Circular No. 40/2014/TT-BYT. This regulation applies to the following cases:

a) Such medicines are used during the whole course of treatment (from the date on which the patient is diagnosed with cancer and is treated with such medicines to the final date of such source of treatment);

b) After receiving treatment at a health facility, the patient moves to another health facility and still uses such medicines as prescribed by physicians within the same course of treatment (except outpatient treatment at inappropriate-level health facility);

c) After a patient stops receiving treatment because of his/her improved general condition, he/she suffers a relapse and is treated with previously prescribed medicines;

d) During the treatment, the patient neither comes under follow-up examinations nor uses medicines continuously as prescribed;

dd) Gefitinib (oral form) is prescribed to a patient who is using Erlotinib (oral form) but suffers side effects from this medicine or the health facility runs out of this medicine or vice versa (i.e. a patient uses Erlotinib (oral form) as a substitute for Gefitinib (oral form)).

Article 8. Terms of reference

If any legislative documents referred to in this Circular are superseded or amended, the new ones shall apply.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the Health Insurance Department) for consideration./.

For the Minister

Deputy Minister

Pham Le Tuan 

APPENDIX 01

LIST OF MODERN MEDICINES AND BIOLOGICALS COVERED BY HEALTH INSURANCE
(Issued together with the Circular No. 30/2018/TT-BYT dated October 30, 2018 of the Minister of Health)