Thông tư 37/2024/TT-BYT quy định nguyên tắc, tiêu chí xây dựng, cập nhật, ghi thông tin, cấu trúc danh mục và hướng dẫn thanh toán đối với thuốc hóa dược, sinh phẩm, thuốc phóng xạ và chất đánh dấu thuộc phạm vi được hưởng của người tham gia bảo hiểm y tế do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

ON PRINCIPLES, CRITERIA FOR DEVELOPMENT, UPDATE, INFORMATION RECORDING, STRUCTURE OF THE LIST, AND REIMBURSEMENT GUIDELINES FOR CHEMICAL DRUGS, BIOLOGICALS, RADIOPHARMACEUTICALS, AND TRACERS COVERED UNDER THE HEALTH INSURANCE SCHEME

Pursuant to the Law on Health Insurance No. 25/2008/QH12 dated November 14, 2008, as amended by Law No. 46/2014/QH13 dated June 13, 2014;

Pursuant to Decree No. 146/2018/ND-CP dated October 18, 2018, of the Government on elaboration of and guidelines for implementation of the Law on Health Insurance, as amended by Decree No. 75/2023/ND-CP dated October 19, 2023;

Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on the functions, duties, powers, and organizational structure of the Ministry of Health;

At the request of the Director General of the Department of Health Insurance, Ministry of Health;

The Minister of Health hereby promulgates the Circular on principles, criteria for development, update, information recording, structure of the list, and reimbursement guidelines for chemical drugs, biologicals, radiopharmaceuticals, and tracers covered under the health insurance scheme.

Chapter I

...

...

...

Article 1. Scope

This Circular provides regulations on principles, criteria for development, update, information recording, structure of the list, and reimbursement guidelines for chemical drugs, biologicals, radiopharmaceuticals, and tracers covered under the health insurance scheme (hereinafter referred to as “drugs”).

Article 2. Principles for developing and updating the drug list

1. Promote the implementation of rational, safe, and effective drug use policies.

2. Meet the requirements of medical examination and treatment, in line with Vietnam’s disease patterns.

3. Ensure the rights of health insurance participants, contributing to gradually reducing the proportion of direct payments by health insurance participants.

4. Ensure the financial sustainability of the health insurance fund in each period.

5. Inherit the previously issued drug list.

6. Refer to the current Essential Medicines List of Vietnam and the World Health Organization (WHO).

...

...

...

Chapter II

CRITERIA FOR DEVELOPING AND UPDATING THE DRUG LIST

Article 3. Criteria for including drugs in the list

1. Single-ingredient drugs shall be considered for inclusion in the list when meeting all of the following criteria:

a) The drug is not subject to the cases specified in Article 5 of this Circular;

b) At least one finished product containing the proposed active ingredient has been granted a valid marketing authorization or import license by the Drug Administration of Vietnam. Drugs under review for registration renewal shall be considered on a case-by-case basis;

c) The drug is included in the diagnostic and treatment guidelines of WHO, the Ministry of Health of Vietnam, specialized medical facilities, competent authorities of other countries, reputable medical and pharmaceutical associations, disease-specific associations, or in the current edition of the National Pharmacopoeia;

d) The drug has a budget impact assessment report in Vietnam;

dd) The drug has scientific evidence on cost-effectiveness in Vietnam or a systematic review on cost-effectiveness. Priority shall be given to scientific evidence on cost-effectiveness in Vietnam.

...

...

...

a) Combination drugs, whose ingredients are already included in the current list as single substance, shall be considered for inclusion if they meet the criteria specified in Points a, b, c, d, Clause 1 of this Article;

b) Combination drugs containing ingredients not yet included in the current list shall be considered for inclusion as per Clause 1 of this Article.

3. Single-ingredient or combination drugs that are already in the list but with a different route of administration, pharmaceutical form, or mineral salts with a different chemical isomer or salt form shall be included in the list when meeting all of the following criteria:

a) The drug has been assessed to be at least as safe and effective as the drugs already included in the list;

b) The drug meets all criteria specified in Points a, b, c, d, Clause 1 of this Article.

4. Radiopharmaceuticals and tracers shall be considered for inclusion in the list when meeting the criteria specified in Points a, b, c, d, Clause 1 of this Article.

5. Orphan drugs included in the Orphan Drug List issued by the Ministry of Health, WHO, drug regulatory authorities of other countries, or reputable medical and pharmaceutical associations, disease-specific associations shall be considered for inclusion in the list when meeting the criteria specified in Points a, b, c, d, Clause 1 of this Article and having systematic review evidence on cost-effectiveness.

Article 4. Criteria for determining reimbursement rates and conditions under the health insurance scheme

1. Drugs proposed for inclusion in the list that meet the criteria specified in Article 3 of this Circular shall be considered for determining reimbursement rates and conditions. Drugs already included in the current list shall be considered for a reduction in reimbursement rates or stricter reimbursement conditions if they meet one of the following criteria:

...

...

...

b) The drug has a higher treatment cost compared to drugs with the same indication included in the current list;

c) The drug requires strict usage conditions for prevention and control of drug resistance or requires specific technical expertise.

2. Drugs already included in the current list shall be considered for an increase in reimbursement rates or broader reimbursement conditions if they meet all of the following criteria:

a) The drug is a first-line treatment option, demonstrates superior therapeutic efficacy, or is included in the diagnostic and treatment guidelines of WHO, the Ministry of Health of Vietnam, specialized medical facilities, competent authorities of other countries, or reputable medical and pharmaceutical associations, disease-specific associations. The drug must also align with treatment needs and the technical capacity of medical facilities;

b) The drug has a budget impact assessment report in Vietnam.

3. For drugs with the same indication and equivalent treatment costs: The reimbursement rate and conditions shall be the same. Drugs with the same indication but higher treatment costs shall be considered for appropriate reimbursement rates and conditions.

4. At the time of assessment as stipulated in Clauses 1 and 2 of this Article, if a pharmaceutical business offers a drug price reduction policy and provides a budget impact assessment report, the reimbursement rate and conditions shall be considered accordingly.

Article 5. Criteria for drug removal from the list

A drug shall be considered for removal from the list if it meets one of the following criteria:

...

...

...

a) The drug or active ingredient has a recommendation for non-use;

b) The drug or active ingredient has a safety warning or its benefits do not outweigh its risks.

2. At the time of assessment, there is no finished drug product containing the active ingredient that has been granted a valid marketing authorization or import license by the Drug Administration of Vietnam. Drugs under review for registration renewal shall be considered on a case-by-case basis. This provision does not apply to emergency drugs, intensive care drugs, antidotes, and essential orphan drugs for treatment.

Chapter III

REGULATIONS ON DRUG INFORMATION RECORDING AND LIST STRUCTURE

Article 6. Regulations on drug information recording in the list

1. Drugs shall be recorded by active ingredient name in the following order of priority:

a) International Non-proprietary Name (INN);

b) The active ingredient name obtaining marketing authorization;

...

...

...

d) In cases where the drug has a generic name according to an active ingredient group, the common name or alternative name shall be specifically noted.

2. The route of administration shall be recorded; strength and pharmaceutical form shall not be recorded, except in specific necessary cases. Certain special cases shall be recorded according to the specific usage or alternative administration route of the drug.

3. For combination drugs: The specific active ingredient ingredients shall be recorded, except for certain drugs where the ingredients are recorded by the active ingredient group name.

4. The drug administration route shall be standardized as follows:

a) Oral includes drugs taken by swallowing, chewing, or dissolving in the mouth;

b) Injection includes intramuscular, subcutaneous, intradermal, intravenous, infusion, intra-articular, intraocular, intravitreal injections, and injections or infusions into body cavities;

c) Topical application includes skin application, skin rubbing, skin patches, skin sprays, washes, mucosal application, and mouth rinses;

d) Suppository includes vaginal, rectal, anal suppositories, enema, sublingual, urethral, buccal administration, subcutaneous implantation;

dd) Respiratory includes nebulized drugs, inhalants (solutions, suspensions, inhalable powders), aerosols, throat sprays, endotracheal administration;

...

...

...

g) Other administration routes shall be specified for drugs with special administration routes or usage methods different from those listed above.

Article 7. Structure of the drug list

1. Drugs shall be categorized into groups based on therapeutic effects. A drug may be classified under a specific group but may also be used for treating diseases in other groups, depending on its approved indications.

2. The list of chemical drugs and biologicals shall be structured into four (04) columns, as follows:

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

b) Column 2: Drug name. Drugs shall be arranged into major groups according to the ATC (Anatomical Therapeutic Chemical) classification system;

c) Column 3: Route of administration as specified in Clause 4, Article 6 of this Circular;

d) Column 4: Notes on reimbursement rates and conditions where applicable, including specific reimbursement percentages, requirements regarding healthcare facilities or technical levels in medical examination and treatment, or specialized requirements for drug use.

3. The list of radiopharmaceuticals and tracers shall be structured into five (05) columns, as follows:

...

...

...

b) Column 2: Drug name;

c) Column 3: Route of administration of the drug;

d) Column 4: Pharmaceutical form of the drug;

dd) Column 5: Unit of drug usage.

Radiopharmaceuticals and tracers shall only be used and reimbursed under the health insurance scheme at healthcare facilities that have been granted authorization to perform diagnostic and therapeutic procedures using radiopharmaceuticals and tracers.

4. Where necessary, a separate drug list may be issued for specific drug groups, types of medical examinations and treatments, types of healthcare facilities, and with an appropriate structure.

Chapter IV

REGULATIONS ON DRUG REIMBURSEMENT

Article 8. Reimbursement principles

...

...

...

2. The health insurance fund shall reimburse drug costs in accordance with the scope of professional practice and the technical service capacity of medical facilities:

a) Medical facilities shall be reimbursed by the health insurance fund for drugs used within the list for performing technical services approved by competent authorities, for treating diseases as per corresponding disease codes, in line with professional requirements, medical conditions, diagnostic and treatment guidelines, the scope of medical practice, available equipment, personnel capacity, and drug prescribing and usage regulations in medical examination and treatment;

b) Medical facilities shall prepare and submit the list of drugs covered under health insurance and used at their facilities to their direct managing authority for inspection and supervision, and to the social insurance agency for contract signing and annexing to the health insurance medical service contract.

3. The health insurance fund shall reimburse prescribed drugs when they align with indications specified in one of the following documents:

a) The drug package insert included in the registration dossier approved by the Ministry of Health;

b) The drug package insert included in the registration dossier of the original brand-name drug or reference biologic approved by the Ministry of Health;

c) Diagnostic and treatment guidelines issued by the Ministry of Health;

d) The latest edition of the Vietnam National Pharmacopoeia.

4. The health insurance fund shall reimburse drugs used off-label or those with contraindications specified in the documents outlined in Clause 3 of this Article in cases of emergency treatment where no alternative drug is available, provided that a medical consultation has been conducted.

...

...

...

a) Drugs or drug batches that have been subject to a suspension of circulation, recall, or revocation of marketing authorization by competent authorities. The non-reimbursement period and scope shall follow the timeline and scope of suspension or recall specified in the respective decision;

b) The cost of drugs that have already been incorporated into the pricing of medical examination and treatment services or bundled case-based payment models as per current regulations;

c) The portion of drug costs covered by the state budget or other funding sources;

d) Drugs used in clinical trials or scientific research.

6. The health insurance fund shall reimburse drugs by active ingredient names as listed in the drug list enclosed with Circular No. 20/2022/TT-BYT dated December 31, 2022, issued by the Minister of Health on the List of Chemical Drugs, Biologicals, Radiopharmaceuticals, and Tracers Covered under the Health Insurance Scheme (hereinafter referred to as Circular No. 20/2022/TT-BYT), or by active ingredient names as stipulated in Clause 1, Article 6 of this Circular in cases where different naming conventions exist for the same active ingredient.

Article 9. Reimbursement of drug wastage costs

1. Drug wastage costs shall be included in management costs and incorporated into the pricing of medical examination and treatment services in accordance with Article 119 of Decree No. 96/2023/ND-CP dated December 30, 2023, of the Government on elaboration of certain provisions of the Law on Medical Examination and Treatment (hereinafter referred to as Decree No. 96/2023/ND-CP).

2. If drug wastage costs are not included in management costs for incorporation into the pricing of technical services, reimbursement shall be carried out as follows:

a) The health insurance fund shall cover drug wastage costs incurred during storage, preservation, transportation, dispensing, preparation, dosage division, and usage, as determined under Circular No. 55/2017/TT-BYT dated December 29, 2017, of the Minister of Health on drug wastage rates and reimbursement of drug wastage costs at medical facilities;

...

...

...

Reimbursed drug wastage cost = Drug wastage rate × Total reimbursed drug cost under health insurance

Article 10. Reimbursement of drugs in specific cases

The health insurance fund shall cover drug costs for insured patients in accordance with Articles 8 and 9 of this Circular, as well as under the following specific conditions:

1. For drugs with different chemical isomers or salt forms of active ingredients (including both single-ingredient and combination drugs) that are included in the reimbursed drug list under the health insurance fund, reimbursement shall be provided if the drug has the same indication as the listed chemical form or salt form. For minerals in the drug list that specify the chemical isomer or salt form, reimbursement shall follow the exact chemical isomer or salt form specified in the list.

2. For drugs classified under one therapeutic group but used for treating diseases of another group, the health insurance fund shall provide reimbursement if the indication complies with Clause 3, Article 8 of this Circular.

3. For cases where, based on medical indications, a patient only uses a portion of the smallest packaging unit of a drug (e.g., drugs used in pediatrics or oncology), and the remaining amount cannot be used (e.g., no other patient with the same indication, remaining quantity insufficient for a full dose, or exceeding storage stability limits), the health insurance fund shall reimburse the full cost of the smallest packaging unit.

4. For liquid or gas-form drugs (such as medicinal oxygen or nitric oxide) that are not packaged for individual use or are administered via hospital-based gas supply systems, reimbursement shall be calculated as follows: Total reimbursed drug quantity = Actual duration of medical gas usage × Gas consumption rate per unit time (minutes or hours)

5. For chemical drugs and biologicals marked with an asterisk (*) in the drug list, medical consultation is required before use, except in emergency cases. For antibiotics marked with an asterisk (*), reimbursement shall be provided only when the prescribing process complies with regulations on antimicrobial stewardship issued by the Ministry of Health.

6. For drugs with reimbursement conditions specified in the "Notes" column of the drug list, reimbursement shall follow the specified rate and conditions. If reimbursement conditions are tied to the type of medical facility, level of medical expertise, or specific professional requirements for drug use, the health insurance fund shall reimburse only when the drug is used at a facility that meets these conditions.

...

...

...

1. For tracers: The medical facility shall determine the actual average consumption rate of tracer kits or vials for each technical service, based on the number of patients undergoing the service. The health insurance fund shall reimburse the cost of tracers as follows: Reimbursed cost = Unit price of tracers × Actual average consumption rate

2. For radiopharmaceuticals: The medical facility shall determine the actual average utilization rate of radiopharmaceuticals based on factors such as radioactive decay rates, supply sources, import cycles, and actual patient usage at the facility. The health insurance fund shall reimburse radiopharmaceutical costs as follows: Reimbursed cost = Unit price (×) Average dose used (:) Actual average utilization rate

3. The calculation and reimbursement of costs for technical services using radiopharmaceuticals and tracers shall be governed by Appendix 1 of this Circular.

Article 12. Reimbursement for cancer drugs and immunomodulatory drugs

The health insurance fund shall reimburse cancer treatment drugs and immunomodulatory drugs when they comply with this Circular and meet the following conditions:

1. Cancer treatment drugs shall be prescribed by a physician specialized in oncology, nuclear medicine, hematology-transfusion medicine, or another qualified practitioner, in accordance with medical examination and treatment laws. The drug must be administered at a medical facility with an oncology department or one that has been approved for oncology treatment under applicable legal regulations, except in cases specified in Clause 2 of this Article.

2. For drugs used in non-cancer treatments or for cancer treatment outside oncology departments, reimbursement shall be provided if the drug is included in the diagnostic and treatment guidelines of the Ministry of Health or the medical facility. If no such guidelines exist, consultation with an oncology specialist is required. In the absence of both guidelines and an oncology specialist, a medical consultation chaired by the facility’s leadership shall be required before prescribing the drug.

Article 13. Reimbursement for drugs prepared or compounded at medical facilities

1. The health insurance fund shall reimburse drugs prepared or compounded at medical facilities, including medicinal oxygen and nitric oxide, when the following conditions are met:

...

...

...

b) The route of administration and reimbursement conditions must align with the drug list issued under this Circular;

c) The drug must be used exclusively within the medical facility, except in cases specified in Clause 5 of this Article;

d) The reimbursed cost of the compounded drug must not exceed the procurement price of equivalent commercial drugs obtained through competitive bidding, with the same active ingredients, strength, and dosage form.

2. Based on usage needs, medical facilities shall:

a) For facilities under the Ministry of Health, other ministries (except the Ministry of Public Security and Ministry of National Defense), provincial health departments, and private medical facilities: The facility’s leadership shall establish the compounding or preparation process, quality standards, and cost structure, as per Clause 3 of this Article, and submit these details to the social insurance agency for reimbursement purposes;

b) For facilities under the People's Armed Forces: Implementation shall follow guidance from the Ministry of Public Security and the Ministry of National Defense.

3. The cost structure of compounded drugs shall be based on:

a) Cost of active ingredients according to the medical facility’s purchase price;

b) Cost of excipients, raw materials, auxiliary materials;

...

...

...

d) Sterilization and disinfection costs (if applicable);

dd) Energy and utility costs, including electricity, water, and fuel;

e) Packaging and consumable costs;

g) Cost of materials, chemicals, and excipients used for quality inspection prior to testing;

h) Quality testing costs;

h) Labor costs;

i) Management and depreciation costs: For management costs and equipment depreciation costs, the health insurance fund shall reimburse according to the adjustment roadmap of factors constituting the price of medical examination and treatment services under the regulations of the competent authority.

4. In cases where a compounded or prepared drug consists of multiple active ingredients, but includes a component that is not listed in the drug list issued with this Circular, the health insurance fund shall reimburse according to the provisions of Clauses 1, 2, and 3 of this Article, except for the cost of the active ingredient that is not included in the drug list issued under this Circular.

5. Medical examination and treatment facilities that manufacture or prepare radiopharmaceuticals must, in addition to complying with the provisions of Clauses 1 and 2 of this Article, implement security measures to prevent the loss of drugs and radioactive drug materials and obtain a license from the Ministry of Science and Technology to conduct radiation-related activities in accordance with the regulations on atomic energy. Radiopharmaceuticals manufactured or prepared under this Clause may be supplied to other medical examination and treatment facilities in accordance with pharmaceutical regulations.

...

...

...

1. For drugs used in telemedicine and remote medical support:

a) Applied to telemedicine and remote medical support activities in accordance with the Law on Medical Examination and Treatment and Decree No. 96/2023/ND-CP ;

b) The health insurance fund shall cover the cost of drugs regardless of the reimbursement conditions stated in the "Notes" column of the drug list enclosed with Circular No. 20/2022/TT-BYT , provided that the following conditions are met:

- The (drug) prescriber must meet the drug use conditions specified in the "Notes" column of the drug list enclosed with Circular No. 20/2022/TT-BYT (if applicable);

- The drug must be procured by the medical facility treating the patient in accordance with bidding regulations.

2. For drugs used in remote medical consultation:

a) Applied to patients receiving emergency treatment at a medical facility, where the drug is used based on specialist guidance or treatment indications during a remote consultation with another medical facility;

b) The health insurance fund shall reimburse the cost of drugs regardless of the reimbursement conditions stated in the "Notes" column of the drug list enclosed with Circular No. 20/2022/TT-BYT , provided that the following conditions are met:

- The remote consultation must be conducted under a professional support contract or a technical transfer contract, with a consultation record following the template specified in Appendix I of Circular No. 49/2017/TT-BYT dated December 28, 2017, issued by the Minister of Health on telemedicine activities;

...

...

...

Article 15. Reimbursement for drugs during an outbreak of a Class A infectious disease

The health insurance fund shall cover drug costs during a Class A infectious disease outbreak, as officially declared under the Law on Prevention and Control of Infectious Diseases, in cases where the patient cannot access a medical facility, under the following conditions:

1. For patients with a scheduled follow-up appointment who cannot visit the designated medical facility due to the outbreak, the patient or medical facility may choose one or more of the following options:

a) The medical facility that issued the appointment transfers the prescribed drugs to another medical facility where the patient can receive continued treatment. The health insurance fund shall reimburse the drug cost to the receiving medical facility, based on the procurement price of the transferring medical facility, within the insurance coverage and reimbursement rate;

b) The patient may authorize a representative to collect medication at the medical examination and treatment facility that issued the follow-up appointment slip or at another medical facility that receives the medication from the original issuing facility.

- The authorization must be in writing, stating the full name, date of birth, and identification details (ID card, citizen identification card, passport, or other valid identity documents) of both the patient and the authorized representative. Upon collection, the authorized representative must present the required identification matching the details in the authorization document.

- The medical facility is responsible for verifying the authenticity of the authorization document and the representative's identification before dispensing the drug.

c) For patients with tuberculosis (TB), latent TB, drug-resistant TB, or HIV/AIDS, and those undergoing non-communicable disease treatment, the issuing medical facility may dispatch personnel or use a third-party service to deliver the drugs to the patient for continued treatment.

2. In cases where inpatients are receiving treatment at medical examination and treatment facilities assigned to epidemic prevention and control, patient triage, and isolation, or at other medical facilities with an indication for patient transfer but are unable to transfer due to the epidemic situation, and where the medical facility does not have the required medication available and no alternative medication at the time of prescription or indication, the medical facility may apply the following measures:

...

...

...

b) Procure the required drug through bidding regulations, with health insurance coverage applicable to all eligible medical facilities, regardless of their specialty or classification, including drugs with specific conditions related to medical specialties, as stated in the "Notes" column of the drug list enclosed with Circular No. 20/2022/TT-BYT .

Article 16. Reimbursement for drugs dispensed at commune health stations

1. The health insurance fund shall reimburse drug costs for insured patients receiving chronic disease management at commune health stations, under the following conditions:

a) The commune health station prescribes and dispenses drugs within its approved scope of practice and technical services;

b) The drug is dispensed by the commune health station under a prescription issued by a higher-level medical facility.

2. In cases where a commune health station has healthcare practitioners assigned or rotated to provide medical examination and treatment, professional support, or technical guidance from a higher-level medical institution as per the assignment or plan of the competent authority, or under a contract; in cases of technology transfer under a contract, remote medical examination and treatment, or telemedicine support in accordance with the legal regulations on medical examination and treatment:

The health insurance fund shall cover the cost of medications in accordance with the competency and professional scope of the assigned healthcare practitioners providing rotational services, guidance, professional support, technology transfer, remote medical examination and treatment, or telemedicine support, as well as the diagnostic and treatment guidelines issued by the Ministry of Health.

Article 17. Guidelines for dispensing chronic disease medication to inpatients undergoing treatment for other conditions

In cases where a patient undergoing outpatient treatment for a chronic disease is hospitalized for another medical condition and runs out of chronic disease medication during the inpatient stay, the health insurance fund shall reimburse as follows:

...

...

...

a) The patient may continue receiving the medication from the chronic disease outpatient department or from the inpatient department, provided that the inpatient physician is qualified to prescribe chronic disease medication;

b) If the inpatient physician is not qualified to prescribe chronic disease medication, a consultation must be held with a physician from the chronic disease outpatient department to issue the prescription. The treatment regimen and prescribed quantity shall be recorded in the medical record and outpatient treatment log, and the medication shall be dispensed together with inpatient treatment medication.

2. If the inpatient treatment facility is different from the chronic disease treatment facility:

a) If the inpatient treatment facility has specialized expertise in treating the chronic disease, the patient may receive the medication at this facility.

The patient must present their outpatient treatment log, which includes the treatment regimen and previously dispensed quantity, to facilitate continued medication supply. If the inpatient physician is qualified to prescribe chronic disease medication, they may issue the prescription. If the inpatient physician is not qualified, a consultation must be held with a qualified physician to issue the prescription. The treatment regimen and prescribed quantity shall be recorded in the medical record and outpatient treatment log, and the medication shall be dispensed together with inpatient treatment medication.

b) If the inpatient treatment facility does not have specialized expertise in treating the chronic disease, the patient’s representative must collect the medication from the original chronic disease treatment facility. The representative must present a valid identification document (such as a national ID card, citizen ID card, passport, or other valid proof of identity) and a written confirmation of inpatient treatment, following the template specified in Appendix 2 of this Circular.

Article 18. Reimbursement for drugs in special cases

Drugs used for political, emergency, epidemic control, warfare, natural disasters, and national-level disasters shall not be subject to the provisions of Articles 3, 4, and 5 of this Circular. The Ministry of Health shall issue specific health insurance reimbursement guidelines for these drugs, based on political mandates assigned by the Communist Party, the State, and the Government, granting direct authority to the Ministry of Health in emergency situations.

Chapter V

...

...

...

Article 19. Implementation

1. The Department of Health Insurance (Ministry of Health) is responsible for:

a) Organizing, guiding, and implementing this Circular;

b) Researching, proposing, and updating amendments and adjustments to principles and criteria to meet treatment needs and align with health insurance fund reimbursement capacity;

c) Collecting, consolidating, analyzing, and evaluating proposals from medical facilities, pharmaceutical businesses, and relevant entities regarding updates to the drug list. If necessary, expert opinions shall be sought from specialized councils, organizations, and professionals to assess safety, efficacy, effectiveness, and pharmacoeconomic evaluations for proposed drugs;

d) Conducting periodic reviews and submitting updates to the drug list to the Minister of Health at least every two years, ensuring alignment with treatment needs and the rights of health insurance participants;

dd) Developing and updating professional guidelines on pharmacoeconomic assessment reports to provide information for the drug list update process;

e) Coordinating with relevant organizations to review recognized medical, pharmaceutical, and disease-specific associations as reference sources for drug list updates;

g) Proposing the establishment of a specialized expert council to evaluate drug applications and related technical matters, ensuring expert knowledge and experience in assessing safety, effectiveness, and cost;

...

...

...

2. Other departments, agencies, and units under the Ministry of Health, including the National Center for Drug Information and Adverse Drug Reaction Monitoring (DI & ADR National Center), shall coordinate in implementing this Circular according to their respective functions, duties, and authorities.

3. Provincial and municipal Departments of Health shall be responsible for:

a) Directing, guiding, disseminating, and implementing this Circular within their jurisdiction;

b) Reviewing and assessing local needs and consolidating recommendations from medical facilities to propose updates or amendments to the drug list for the Ministry of Health.

4. The Social Insurance Agency is responsible for:

a) Providing the Ministry of Health with timely and complete information on health insurance reimbursement data to facilitate review and decision-making during the drug list update process;

b) Processing reimbursement payments for drugs used in health insurance-covered medical examination and treatment, in accordance with this Circular.

5. Medical facilities are responsible for:

a) Develop a list of chemical drugs, biological products, radiopharmaceuticals, and tracers used at the facility, including those compounded or prepared in-house (if applicable), and submit it to the social insurance agency that has signed the health insurance medical examination and treatment contract. This submission should include the procurement plan, contractor selection results, compounding or preparation procedures, quality standards, pricing, or costs of the drugs compounded or prepared at the medical facility to serve as the basis for reimbursing health insurance-covered medical examination and treatment expenses.

...

...

...

c) Review drug usage, assess the demand for drugs at the facility, and propose the inclusion or removal of drugs from the list. These proposals shall be submitted to the Department of Health Insurance under the Ministry of Health (for medical examination and treatment facilities under the Ministry of Health and other ministries or sectors) or to the provincial/municipal Department of Health (for medical facilities under provincial/municipal management).

d) Ensure the scientific accuracy and reliability of the proposed information related to the drug list, in alignment with the professional guidelines of the Ministry of Health.

6. Drug manufacturers, drug registration establishments, drug importers, and drug distributors are responsible for providing information about the drugs they manage whenever adjustments or additions are required. They must ensure the scientific accuracy and validity of the proposed information related to the drug list, in accordance with the professional guidelines of the Ministry of Health.

Article 20. Implementation

1. This Circular comes into force as of January 1, 2025.

2. The provisions in Article 7 of this Circular shall not apply to health insurance reimbursement for medical examination and treatment costs until the Minister of Health issues a new regulation on the list, reimbursement rates, and conditions for chemical drugs, biologicals, radiopharmaceuticals, and tracers covered under the health insurance scheme.

3. Amendments to Clause 1(d), Article 2 of Circular No. 20/2022/TT-BYT are as follows:

a) The phrase "has been classified by a competent state authority as having a technical specialization equivalent to Level III" in the third paragraph shall be amended to "has been classified by a competent state authority as having a technical specialization equivalent to Level III before January 1, 2025";

b) The phrase "has not been classified under technical specialization" in the fourth paragraph shall be amended to "has not been classified under technical specialization before January 1, 2025".

...

...

...

5. In cases where a patient is admitted to a medical facility for examination and treatment before the effective date of this Circular but completes treatment after its effective date, the provisions of this Circular shall apply.

Article 21. Reference provisions

If the legal documents referenced in this Circular are amended, supplemented, or replaced, the new or amended legal documents shall apply.

During the implementation process, if any difficulties or issues arise, agencies, organizations, and individuals are encouraged to report them to the Ministry of Health (Department of Health Insurance) for consideration and resolution./.

PP. MINISTER
DEPUTY MINISTER




Tran Van Thuan

APPENDIX 1

FORM FOR STATISTICAL REPORTING OF TECHNICAL SERVICES USING RADIOPHARMACEUTICALS AND TRACERS
(Issued in conjunction with Circular No. 37/2024/TT-BYT dated November 16, 2024, of the Minister of Health)

...

...

...

MEDICAL FACILITY: ……………………………………………………………………

No.

Type of service

Tracer

Radiopharmaceutical

Proposed reimbursement rate (VND)

Name

Price (VND)

Tracer name

...

...

...

Unit price (VND)

Manufacturer’s standard usage rate

Actual average usage rate

Total cost (VND)

Name of the radiopharmaceutical

Unit of measurement (mci)

Unit price (VND)

Average dose

Actual average utilization rate

...

...

...

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

...

...

...

(10)

(11)

(12)

(13)

(14)

(15)

(16)

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

Prepared by
(Signature, full name)

Head of Department
(Signature, full name)

[Location]…….., [date]…………

Head of Medical Facility

(Signature, full name, official stamp)

Notes:

...

...

...

- Column (2): Name of the technical service using radiopharmaceuticals or tracers.

- Column (3): Price of the technical service excluding the cost of radiopharmaceuticals and tracers, as approved by the competent authority.

- Columns (4) to (9): Criteria for calculating the cost of tracers used in the technical service, including:

+ Column (4): Name of the tracer.

+ Column (5): Unit of measurement (kit or vial).

+ Column (6): Unit price of the tracer.

+ Column (7): Manufacturer’s recommended usage rate: Usage rate of the tracer as specified by the manufacturer for each technical service.

+ Column (8): Average actual usage rate:

Notes: Medical facilities shall calculate the average actual usage rate of the tracer kit for each technical service based on the technique used and the number of patients undergoing the service at the facility. For SPECT myocardial perfusion imaging (rest phase) using the tracer Methoxyisobutylisonitrile (MIBI), one MIBI kit can be used for four patients. Therefore, the actual usage rate for the tracer is 1/4. The medical facility should enter this value in Column (8) for the corresponding technical service.

...

...

...

- Columns (10) to (15): Criteria for calculating the cost of radiopharmaceuticals used in technical services, including:

+ Column (10): Name of the radiopharmaceutical.

+ Column (11): Unit of measurement for the radiopharmaceutical.

+ Column (12): Unit price of the radiopharmaceutical (based on the procurement cost at the medical facility).

+ Column (13): Average dose of the radiopharmaceutical used in the technical service.

+ Column (14): Average actual utilization rate of the radiopharmaceutical. Medical facilities shall determine the average actual utilization rate of radiopharmaceuticals based on the decay rate of the radioactive substance, the supply source of radiopharmaceuticals, the procurement cycle, and the actual patient demand for radiopharmaceutical use at the facility.

For example, For I-131, based on its half-life (T₁/₂) of 8 days, if a medical facility procures it on a 15-day cycle, the utilization rate of the radiopharmaceutical is initially 100% on the first day. However, after 8 days, the remaining activity is only 50% due to radioactive decay, and after 16 days, it further decreases to 25% (as the remaining 50% undergoes another 50% decay). Based on the actual patient demand for the radiopharmaceutical, if the facility determines that the average actual utilization rate of I-131 is 50%, it should enter '50%' in Column (14) for I-131.

+ Column (15): Total cost of the radiopharmaceutical = (Column 12) x (Column 13) ÷ (Column 14).

- Column (16): Total cost of the technical service, including radiopharmaceutical and tracer costs = (Column 3) + (Column 9) + (Column 15)./.

...

...

...

APPENDIX 2

INPATIENT TREATMENT CERTIFICATE FORM
(Issued together with Circular No. 37/2024/TT-BYT dated November 16, 2024, of the Minister of Health)

GOVERNING AGENCY
………….
TREATMENT FACILITY
…………….

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------

INPATIENT TREATMENT CERTIFICATE

Patient’s full name:

Gender: .………………………………………………………………

Date of birth: ……………………………………………………………...

...

...

...

Diagnosis: ……………………………………………………………………………….

Currently undergoing inpatient treatment at Department: ………………………………………………………………...

[Location]…….., [date]………………
Certification by the treatment facility
(Signature and official seal)[1]

[1] Signed and stamped by the head of the facility or an authorized representative.