Circular No. 30/2018/TT-BYT promulgates the List and Proportions, Conditions for Payment of Chemical Drugs, Biological Products, Radioactive Medicines, and Markers within the Scope of Coverage for Health Insurance Participants

Article 1. The Lists attached to this Circular

1. The List of chemical drugs and biological products within the scope of benefits for insured persons participating in health insurance is specified in Appendix 01 attached to this Circular (hereinafter referred to as Appendix 01).

2. The List of radioactive drugs and radiopharmaceuticals within the scope of benefits for insured persons participating in health insurance is specified in Appendix 02 attached to this Circular (hereinafter referred to as Appendix 02).

Article 2. Structure of the Medicine List and Classification of Usage

1. The List of chemical drugs and biological products in Appendix 01 is arranged into 27 major groups according to therapeutic effects, divided into 8 columns, specifically as follows:

a) Column 1: Records the serial number of the medicine in the List;

b) Column 2: Records the name of the drug. The drug name is recorded according to the International Nonproprietary Name (INN) nomenclature. In cases where there is no name according to the INN nomenclature, it is recorded according to the active substance approved for circulation. Drugs are arranged into 27 major groups according to the ATC (Anatomical Therapeutic Chemical) code;

c) Column 3: Records the route of administration and form of the drug; does not record the dosage, except for certain forms that have clear differences in efficacy and therapeutic effect. The routes of administration in the List in Appendix 01 are unified as follows:

- Oral route includes oral, sublingual, buccal, and rectal tablets;

- Parenteral route includes intramuscular, subcutaneous, intradermal, intravenous, infusion, intra-articular, intraocular, and intravitreal injections;

- Topical route includes topical creams, lotions, patches, sprays, and washes;

- Insertion route includes vaginal, rectal suppositories, and enemas;

- Respiratory route includes nebulizers, inhalers (solutions, suspensions, powders for inhalation), and aerosols;

- Ophthalmic route includes eye drops and ointments; otic route includes ear drops; nasal route includes nasal drops and sprays;

- Other routes and forms of administration are specifically recorded in the List for certain drugs with special forms of administration different from those mentioned above;

d) Columns 4, 5, 6, and 7: Record the hospital level at which the drug can be used. Chemical drugs and biological products listed in the List in Appendix 01 can be used at healthcare facilities according to hospital levels, specifically as follows:

- Special class and Class I hospitals use medicines specified in Column 4;

- Class II hospitals use medicines specified in Column 5;

- Hospitals at Level III and Level IV, including multi-disciplinary clinics under general hospitals or district, county, town, city-level medical centers, use drugs specified in column 6;

- Healthcare facilities providing outpatient and inpatient services such as commune health stations, urban health stations, workplace health stations, and equivalent facilities use drugs specified in column 7;

- For state-owned healthcare facilities that have signed health insurance contracts but have not been classified into hospital levels: Based on their professional capacity, medical equipment, and technical service catalog approved by competent authorities, the Department of Health shall take the lead in coordinating with the Social Insurance Provincial Branch to unify and decide on the use of drugs at appropriate hospital levels;

- For state-owned healthcare facilities under the military and police systems that have signed health insurance contracts but have not been classified into hospital levels: Based on their professional capacity, medical equipment, and technical service catalog approved by competent authorities, the Department of Health shall take the lead in coordinating with the direct management agencies of these healthcare facilities and the Social Insurance Provincial Branch to unify and decide on the use of drugs at appropriate hospital levels;

- For private hospitals that have signed health insurance contracts but have not implemented specialized technical classification to determine equivalent levels: Based on their professional capacity, medical equipment, and technical service catalog approved by competent authorities, the Department of Health shall take the lead in coordinating with the Social Insurance Provincial Branch to unify and decide on the use of drugs at appropriate specialized technical classification levels;

- For private clinics that have signed health insurance contracts but have not implemented specialized technical classification: Based on their professional capacity, medical equipment, and technical service catalog approved by competent authorities, the Department of Health shall take the lead in coordinating with the Social Insurance Provincial Branch to unify and decide on the use of drugs at these facilities, but not exceeding the drug list of Level III hospitals;

- If healthcare facilities can perform higher-level technical services according to specialized technical classification, they may use drugs according to the drug list specified for higher levels, consistent with the approved technical services. Healthcare facilities shall submit the drug list to social insurance agencies as the basis for payment;

- If provincial specialty hospitals use drugs not accompanied by technical services, based on their professional capacity, medical equipment, treatment needs, and diagnostic and treatment guidelines issued by the Ministry of Health, the Department of Health shall take the lead in coordinating with the Social Insurance Provincial Branch to determine the drug list that can be used beyond the hospital level, but not exceeding the level of provincial general hospitals;

đ) Column 8: Records specific conditions, payment ratios, and notes for some medicines.

2. The List of radioactive drugs and radiopharmaceuticals in Appendix 02 includes 5 columns:

a) Column 1: Record the serial number of the drug in the list;

b) Column 2: Records the name of the drug. The drug name is recorded according to the International Nonproprietary Name (INN) nomenclature. In cases where there is no name according to the INN nomenclature, it is recorded according to the active substance approved for circulation;

c) Column 3: Record the route of administration of the drug;

d) Column 4: Records the form of use of the medicine;

đ) Column 5: Record the unit of use of the drug.

Radioactive drugs and radiopharmaceuticals in Appendix 02 are not classified by hospital levels and can only be used at healthcare facilities authorized by competent authorities to perform diagnosis and treatment using radiation;

Article 3. General Principles for Reimbursing Medication Costs for Patients Participating in Health Insurance

1. The Health Insurance Fund pays the cost of drugs based on the actual quantity used for patients and the purchase price of the healthcare facility in accordance with the laws on tendering for drug purchases, consistent with the scope of benefits and entitlement levels prescribed by the Health Insurance Law and guiding documents.

2. The Health Insurance Fund shall pay for medicines that are prescribed in accordance with the instructions in the drug registration dossier approved by the Ministry of Health or the diagnostic and treatment guidelines issued by the Ministry of Health. In cases where there are no instructions in the drug registration dossier approved by the Ministry of Health or in the diagnostic and treatment guidelines of the Ministry of Health but such medicines are necessary for treatment, the Ministry of Health will establish a Council to examine each specific case.

3. The Health Insurance Fund shall not pay for medicines or batches of medicines that have been decided to be suspended from circulation and recalled according to the guidance documents of the Ministry of Health.

4. The Health Insurance Fund shall not pay for the following cases:

a) Costs of medicines that have been included in the price of technical service fees, outpatient examination fees, inpatient bed days, or package prices per case as stipulated under current regulations;

b) The portion of costs of medicines that have been paid for by the state budget or other sources;

c) Medicines used in clinical trials or scientific research.

Article 4. Provisions on payment for certain medicines

1. Other forms of chemical isomers or salts of active ingredients (including single-component and multi-component combination forms, except vitamins and minerals) listed in Appendix 01 shall be covered by the Health Insurance Fund if they have the same indication as the chemical form or medicine name listed in the Medicine List.

2. Medicines classified in this group used to treat diseases belonging to another group shall be covered by the Health Insurance Fund if they meet the appropriate indications as stipulated in Clause 2, Article 3 of this Circular.

3. Certain medicines with specified conditions and reimbursement rates shall be covered by the Health Insurance Fund according to the provisions in Column 8 of the Medicine List in Appendix 01.

4. In cases where, based on professional indications, patients only use part of the quantity of medicine in the smallest unit packaging (for example, medicines used in pediatric specialties, oncology) and the remaining quantity cannot be used (for example, there are no other patients with the same indication, the remaining quantity is insufficient for dosage, or has exceeded the storage period), the Health Insurance Fund shall cover the entire cost based on the price of the smallest unit packaging.

5. Medicines marked with an asterisk (*) must be reviewed before use, except in emergency situations. For antibiotics marked with an asterisk (*), the Health Insurance Fund shall cover the cost when the prescription process follows the guidelines for managing and using antibiotics in hospitals as stipulated by the Ministry of Health.

6. Regarding cancer treatment medicines:

a) They can only be used for cancer treatment at healthcare facilities with cancer treatment functions (including oncology, hematology, and nuclear medicine centers; oncology, hematology, and nuclear medicine departments in specialized or general hospitals) and must be prescribed by doctors who have obtained a license to practice in oncology or hematology;

b) If used to treat other non-cancer diseases, the Health Insurance Fund shall cover the cost according to the diagnostic and treatment guidelines of the Ministry of Health or the hospital. In cases where there are no diagnostic and treatment guidelines, a consultation with an oncologist is required. If there are no diagnostic and treatment guidelines and no oncologist available, a consultation under the chairmanship of the hospital leadership is required before prescribing the use of these medicines.

7. Medicines self-manufactured or compounded by healthcare facilities shall be covered by the Health Insurance Fund when:

a) The active ingredient of the medicine is listed in Appendix 01;

b) It conforms to the route of administration, form, and hospital level specified in Appendix 01;

c) It is used at that healthcare facility;

d) The head of the healthcare facility is responsible for approving the compounding process, quality standards, and price of the medicine; coordinating with the social insurance agency to agree on the price of the medicine as the basis for payment. The product cost is established based on: raw material costs; loss costs; packaging costs; labor costs; compounding costs including electricity, water, fuel; testing costs and other costs (if any).

State-owned enterprises that have been assigned by the Ministry of Agriculture and Rural Development to conduct offshore wind power project surveys before the effective date of this Circular shall continue to implement according to the assigned documents; any new matters arising after the effective date of this Circular shall be implemented in accordance with the provisions of this Circular.

1. The Department of Health Insurance, Ministry of Health shall be responsible for:

a) Directing, guiding, and inspecting the management, use, and payment of health insurance medicine costs at healthcare facilities;

b) Resolving any issues arising during implementation;

c) Updating, adjusting, amending, and supplementing the list of medicines to meet treatment needs and be consistent with the Health Insurance Fund's payment capacity;

d) Leading the coordination with the Department of Medical Examination and Treatment, the Department of Drug Management, and related units to establish a professional advisory council to review and decide on payments for cases without instructions in the drug registration dossier approved by the Ministry of Health or in the diagnostic and treatment guidelines of the Ministry of Health but necessary for treatment.

2. Vietnam Social Security shall be responsible for:

a) Implementing and directing provincial social insurance agencies to coordinate with the Provincial Health Departments and healthcare facilities in organizing implementation and paying medicine costs in accordance with this Circular and relevant laws;

b) Coordinating with related agencies to resolve issues arising during implementation.

3. Military and Police Healthcare shall be responsible for: Directing the management bodies of military and police healthcare facilities to cooperate with the Provincial Health Departments and provincial social insurance agencies in reviewing and deciding on the use of medicines by military and police healthcare facilities that have signed health insurance contracts but have not been classified according to Point d, Clause 1, Article 2 of this Circular.

4. Provincial Health Departments shall be responsible for:

a) Implementing, directing, guiding, inspecting, and supervising the establishment of medicine lists, management, use, and payment of medicine costs at healthcare facilities within their jurisdiction.

b) Chair and coordinate with relevant units to determine the use of drugs at medical examination and treatment facilities as specified in Point d Clause 1 Article 2 of this Circular.

a) Building a medicine list for use at their facility, including medicines self-manufactured or compounded by the facility (if applicable), and submitting it to the social insurance agency where the health insurance examination and treatment contract is signed along with the procurement plan, procurement results, compounding procedures, quality standards, and costs of compounded medicines for health insurance reimbursement purposes; ensuring transparency and rational selection of medicines with quality;

a) Develop a list of drugs for use at the unit, including those drugs used to perform higher-level technical services according to the specialized technical level classification, and drugs self-manufactured by the medical examination and treatment facility;

b) Supply fully, promptly, and in accordance with regulations, meeting the treatment needs of insured patients based on the established drug list. The medical examination and treatment facility shall submit to the social insurance agency where the health insurance contract is signed the list of drugs used to perform higher-level technical services according to the specialized technical level classification and the list of self-manufactured or compounded drugs for reimbursement purposes;

c) Manage prescription and drug usage in accordance with regulations, ensuring safety, rationality, economy, and quality of drugs used at the unit; conduct consultations when using drugs marked with an asterisk (*) in accordance with professional rules; timely and accurately compile and settle payments by type, quantity, and price;

d) In case of changes or additions to the drug list used at the unit, the medical examination and treatment facility shall submit the revised and supplemented drug list to the social insurance agency for reimbursement purposes;

đ) In cases where it is necessary to propose modifications, removal, or addition of new drugs to the drug list prescribed in this Circular to suit actual conditions and meet patient treatment requirements, medical examination and treatment facilities under the Ministry of Health shall send written proposals to the Department of Health Insurance, Ministry of Health, while those under provincial departments of health shall send their proposals to the respective provincial departments of health for consolidation and submission to the Ministry of Health;

Article 6. Effectiveness

1. This Circular shall take effect from January 1, 2019.

2. Circular No. 40/2014/TT-BYT dated November 17, 2014, promulgating and guiding the implementation of the list of essential medicines within the scope of payment by the Health Insurance Fund (hereinafter referred to as Circular No. 40/2014/TT-BYT); Circular No. 36/2015/TT-BYT dated October 29, 2015, amending and supplementing certain provisions of Circular No. 40/2014/TT-BYT (hereinafter referred to as Circular No. 36/2015/TT-BYT), and Article 4 of Circular No. 50/2017/TT-BYT dated December 29, 2017, of the Ministry of Health, amending and supplementing related provisions on cost reimbursement for medical examinations and treatments (hereinafter referred to as Circular No. 50/2017/TT-BYT) shall cease to be effective from the date this Circular takes effect.

Article 7. Transitional Provisions

1. In cases where insured patients admitted for inpatient care before January 1, 2019 but continue to receive treatment at medical examination and treatment facilities, the provisions of Circular No. 40/2014/TT-BYT, Circular No. 36/2015/TT-BYT, and Circular No. 50/2017/TT-BYT shall apply until discharge; including prescriptions issued immediately following the completion of inpatient treatment.

2. For drugs or dosage forms of drugs within the scope of benefits for insured persons under Circular No. 40/2014/TT-BYT, Circular No. 36/2015/TT-BYT, and Circular No. 50/2017/TT-BYT but not within the scope of benefits for insured persons under this Circular, or drugs restricted to hospital levels under this Circular, the Health Insurance Fund shall continue to reimburse medical examination and treatment facilities until the contracted supply of such drugs is exhausted.

For private medical examination and treatment facilities applying the procurement of drugs as stipulated in Article 52 of the Bidding Law: The Health Insurance Fund shall reimburse the quantity of drugs purchased before January 1, 2019 and used up to March 31, 2019.

3. For drugs within the scope of benefits for insured persons under Circular No. 40/2014/TT-BYT, Circular No. 36/2015/TT-BYT, and Circular No. 50/2017/TT-BYT but with changes in reimbursement rates, conditions, or expanded hospital levels under this Circular, the Health Insurance Fund shall reimburse according to the rates, conditions, and hospital levels specified in this Circular from January 1, 2019, except as provided in Clause 1 and Clause 4 of this Article.

4. For cancer patients who have been using Doxorubicin, injectable form, liposomal; Erlotinib, oral; Gefitinib, oral; Sorafenib, oral (for advanced hepatocellular carcinoma and renal cell carcinoma) before January 1, 2015 and continue to use these drugs after January 1, 2019, they will continue to be reimbursed at 100%. For cancer patients who have been using Everolimus, injectable and oral; L-asparaginase erwinia, injectable; Paclitaxel, injectable, liposomal and polymeric micelle form before January 1, 2019 and continue to use them after January 1, 2019, or Sorafenib, oral (for advanced renal cell carcinoma) after January 1, 2015 and continue to use it after January 1, 2019, the Health Insurance Fund will continue to reimburse according to the rates specified in Circular No. 40/2014/TT-BYT. This provision applies in the following cases:

a) Until the end of the treatment course (from the time the patient is diagnosed and begins treatment until the end of treatment);

b) When, after treatment at a medical examination and treatment facility, the patient transfers to another facility and is prescribed the same drug by a doctor, still within the treatment regimen (except for out-of-network outpatient care);

c) If the patient's condition stabilizes during treatment and stops treatment, and the disease recurs, the doctor prescribes the previously used drug;

d) During the treatment period, if the patient does not return for follow-up visits as scheduled and does not take the medication continuously;

đ) In cases where a patient using oral Erlotinib experiences side effects or the medical examination and treatment facility runs out of the drug, the doctor may switch to oral Gefitinib and vice versa (switching from oral Gefitinib to oral Erlotinib).

Article 8. Reference Provisions

In case the referenced documents in this Circular are replaced or amended, they shall be applied according to the replaced or amended documents.

During the implementation process, if there are difficulties or obstacles, units are requested to report to the Ministry of Health (Health Insurance Department) for consideration and resolution./.