Circular No. 37/2024/TT-BYT stipulates the principles, criteria for building and updating information, structure of the list, and payment guidance for chemical drugs, biological products, radioactive drugs, and markers within the scope of health insurance benefits for participants, issued by the Minister of Health.

CIRCULAR

Regulations on principles, criteria for building, updating, recording information, structure list and guidance on payment for chemical drugs, biological products, radioactive drugs and marking substances within the scope of benefits for persons participating in health insurance

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Decree No. Government Decree No. 146/2018/NĐ-CP dated October 18, 2018 detailing and guiding implementation measures of the Health Insurance Law amended and supplemented by Decree No. Government Decree No. 75/2023/NĐ-CP dated October 19, 2023;

Decree No. Government Decree No. 95/2022/NĐ-CP dated November 15, 2022 stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Health Insurance Department, Ministry of Health,

The Minister of Health issues this Circular regulating principles, criteria for building, updating, recording information, structure of the list and guidance on payment for chemical drugs, biological products, radioactive drugs and marking substances within the scope of benefits for persons participating in health insurance.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates principles, criteria for building, updating, recording information, structure of the list and guidance on payment for chemical drugs, biological products, radioactive drugs and marking substances within the scope of benefits for persons participating in health insurance (hereinafter referred to as drugs).

Article 2. Principles for building and updating the drug list

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

2. Meet requirements for diagnosis and treatment, suitable for Vietnam's disease model.

3. Ensure the rights of health insurance participants, contributing to gradually reducing the direct payment ratio of health insurance participants.

4. Ensure the ability of the health insurance fund to pay out 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).

7. Create conditions for the development of primary healthcare.

Chapter II
CRITERIA FOR BUILDING AND UPDATING THE LIST OF MEDICINES

Article 3. Criteria for including drugs in the list

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

a) The drug does not fall under the cases specified in Article 5 of this Circular;

b) The drug has at least one finished product containing the active ingredient proposed for inclusion in the list that has been granted a circulation registration certificate or import permit by the Drug Administration Department which remains valid. Drugs under review for extension of registration file may be considered on a case-by-case basis;

c) The drug is included in the WHO's or Vietnam's Ministry of Health's diagnostic and treatment guidelines or those of specialized healthcare facilities or authorized agencies of other countries or reputable medical and pharmaceutical associations or disease societies or in the current National Pharmacopoeia monograph;

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

đ) The drug has scientific evidence on cost-effectiveness in Vietnam or a systematic review of cost-effectiveness. Priority is given to scientific evidence on cost-effectiveness in Vietnam.

2. Combination drugs shall be considered for inclusion in the list when meeting all of the following criteria:

a) Combination drugs where individual components are already listed in the current list as single ingredients shall be considered for inclusion in the list when meeting all criteria specified in points a, b, c, d of Clause 1 of this Article;

b) Combination drugs with components not yet listed in the current list shall be considered for inclusion in the list according to the provisions of Clause 1 of this Article.

3. Single-component drugs or combination drugs already listed but with different routes of administration, dosage forms, or mineral substances already listed but with different stereoisomers or salts shall be included in the list when meeting all of the following criteria:

a) They are assessed as being no less safe and effective than existing drugs in the list;

b) They meet all criteria specified in points a, b, c, d of Clause 1 of this Article.

4. Radioactive drugs and marking substances shall be considered for inclusion in the list when meeting all criteria specified in points a, b, c, d of Clause 1 of this Article.

5. Rare drugs included in the rare drug list issued by the Ministry of Health or the WHO's rare drug list or rare drug lists of drug regulatory authorities of other countries or reputable medical and pharmaceutical associations or disease societies shall be considered for inclusion in the list when meeting all criteria specified in points a, b, c, d of Clause 1 of this Article and having systematic reviews on cost-effectiveness.

Article 4. Criteria for considering drugs to specify reimbursement ratios and conditions

1. Drugs proposed to be included in the list that meet the criteria specified in Article 3 of this Circular shall be considered to specify reimbursement ratios and conditions, or drugs already in the current drug list shall be considered to reduce reimbursement ratios or impose stricter payment conditions if they meet any of the following criteria:

a) Drugs with high treatment costs or significant budget impact;

b) Drugs with higher treatment costs than those with the same indication currently in the drug list;

c) Drugs requiring strict usage conditions to prevent or combat antibiotic resistance or drugs requiring specialized technical capacity conditions.

2. Drugs already in the current drug list shall be considered to increase reimbursement ratios or broaden payment conditions if they meet all of the following criteria:

a) They are first-line choices or have superior therapeutic effects, or are included in the diagnostic and treatment guidelines of the World Health Organization (WHO), the Ministry of Health of Vietnam, specialized medical facilities, or competent authorities of other countries, or reputable medical and pharmaceutical associations, and are consistent with treatment needs and the professional capabilities of medical facilities;

b) There is a budget impact assessment report in Vietnam.

3. Drugs with the same indication and equivalent treatment costs shall have the same reimbursement ratio and similar payment conditions. Drugs with the same indication but higher treatment costs shall be considered to set appropriate reimbursement ratios and payment conditions.

4. At the time of considering cases stipulated in Clauses 1 and 2 of this Article, if a pharmaceutical business has a drug discount policy and provides a budget impact assessment report, it shall be considered for appropriate reimbursement ratios and payment conditions.

Article 5. Criteria for Removing Drugs from the List

Drugs shall be considered for removal from the list if they meet any of the following criteria:

1. Drugs or active ingredients recommended not to be used by WHO, the Ministry of Health of Vietnam, drug regulatory agencies of other countries, or reputable medical and pharmaceutical associations, or suggested or recommended by relevant professional organizations or the Expert Advisory Council on the Drug List (hereinafter referred to as the Expert Advisory Council) under any of the following circumstances:

a) Drugs or active ingredients recommended not to be used;

b) Drugs or active ingredients with safety warnings or benefits not exceeding risks.

2. At the time of consideration, there is no finished drug containing the active ingredient that still has an effective registration certificate or import permit issued by the Drug Administration. Drugs undergoing review for extension of registration application shall be considered on a case-by-case basis. This provision does not apply to emergency drugs, critical care drugs, antidotes, or rare essential treatment drugs.

Chapter III
PROVISIONS ON RECORDING DRUG INFORMATION AND THE STRUCTURE OF THE LIST

Article 6. Provisions on Recording Drug Information in the List

1. Drugs shall be recorded by generic name in the following priority order:

a) International Non-proprietary Name (INN);

b) Active ingredient approved for circulation;

c) Active ingredient in the diagnostic and treatment guidelines of the Ministry of Health;

d) In the case of drugs with a common name according to the active ingredient group, the specific common name or other name shall be noted.

2. Record route of administration; do not record dosage or formulation except in necessary cases. For some special cases, record the specific usage and route of administration of the drug.

3. In the case of combination drugs: Specifically record the components of combined active ingredients, except for some drugs that record components by active ingredient group name.

4. The route of administration of drugs shall be uniformly recorded as follows:

a) Oral including oral, chewable, and lozenge forms;

b) Injection including intramuscular, subcutaneous, intradermal, intravenous, infusion, intra-articular, intraocular, intracameral, and cavity injection or infusion;

c) External use including topical creams, lotions, patches, sprays, washes, and mucosal applications;

d) Insertion including vaginal, rectal, enema, sublingual, urethral, buccal, and subcutaneous implants;

đ) Respiratory including nebulizers, inhalers (solutions, suspensions, powders for inhalation), aerosols, throat sprays, endotracheal pumps;

e) Eye drops including eye drops and eye ointments. Ear drops including ear drops. Nose drops including nasal drops and nasal sprays;

g) Other routes of administration shall be specifically recorded for certain drugs with special routes of administration different from those listed above.

Article 7. Structure of the Drug List

1. Drugs are classified into groups based on therapeutic effects. A drug may be included in one group but used to treat diseases belonging to another group according to appropriate prescription.

2. The list of chemical drugs and biological products is divided into four (4) columns, specifically as follows:

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

b) Column 2: Record the name of the drug. Drugs are arranged according to major groups, based on the ATC code (Anatomical Therapeutic Chemical);

c) Column 3: Record the route of administration of the drug as prescribed in Clause 4, Article 6 of this Circular;

d) Column 4: Note the regulations on payment ratio and payment conditions for the drug when necessary, including the specific payment ratio of the drug, conditions regarding healthcare facilities or specialized technical services in diagnosis and treatment, or professional requirements for drug use.

3. The list of radioactive drugs and radiopharmaceuticals is divided into five (5) columns, specifically as follows:

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

b) Column 2: Record the name of the drug;

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

d) Column 4: Record the dosage form of the drug;

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

Radioactive drugs and radiopharmaceuticals can only be used and reimbursed under health insurance at healthcare facilities permitted by competent authorities to perform diagnostic and treatment activities using radioactive materials and radiopharmaceuticals.

4. In cases where necessary, a separate drug list may be issued for a group of drugs, a form of medical examination and treatment, a type of healthcare facility, and a suitable structure.

Chapter IV
REGULATIONS ON DRUG PAYMENTS

Article 8. Principles of Payment

1. The Health Insurance Fund pays the cost of drugs used in medical examinations and treatments for insured persons, including the actual cost of drugs used for patients in one medical examination and treatment session based on the purchase price of the healthcare facility according to the legal provisions on bidding; the level of benefit and scope of entitlement according to the legal provisions on health insurance, and the loss of drugs (if any) at the healthcare facility.

2. The Health Insurance Fund pays in accordance with the scope of professional activities and the capacity to provide technical services of the healthcare facility:

a) Healthcare facilities are reimbursed by the Health Insurance Fund for drugs used in the list to perform approved technical services, treat diseases according to appropriate disease codes, professional requirements, clinical guidelines, scope of medical examination and treatment, equipment and human resources conditions of the facility, and regulations on prescription and drug use in medical examinations and treatments;

b) Healthcare facilities establish and submit the list of drugs within the scope of entitlement for insured persons used at their facility to the direct management agency for inspection and supervision; submit to the social insurance agency to sign the medical examination and treatment insurance contract and its annex.

3. The Health Insurance Fund pays in cases where the drug prescription is consistent with one of the following documents:

a) The drug usage guide attached to the drug registration dossier approved by the Ministry of Health;

b) The drug usage guide attached to the drug registration dossier of the original brand-name drug or reference biological product approved by the Ministry of Health;

c) Clinical practice guidelines of the Ministry of Health;

d) The latest version of the National Pharmacopoeia of Vietnam.

4. The Health Insurance Fund pays in cases where the drug is used without a prescription or contraindicated for the patient as recorded in the documents stipulated in Clause 3 of this Article for emergency treatment of the patient and there is no alternative drug available, after consultation.

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

a) Drugs or batches of drugs that have been officially suspended from circulation or recalled or had their registration certificates revoked by competent authorities. The time and scope of non-payment of health insurance are calculated according to the time and scope of suspension or recall recorded in the suspension or recall notice;

b) Costs of drugs that have been incorporated into the service fee for medical examination and treatment or the package fee according to the current regulations;

c) The portion of costs of drugs paid by the state budget or other sources of funding;

d) Drugs used in clinical trials or scientific research.

6. The Health Insurance Fund pays for drugs listed by active ingredient in the drug list issued together with Circular No. 20/2022/TT-BYT dated December 31, 2022, promulgated by the Minister of Health on the List of Chemical Drugs, Biological Products, Radioactive Drugs, and Radiopharmaceuticals within the scope of entitlement for insured persons (hereinafter referred to as Circular No. 20/2022/TT-BYT) or according to the active ingredient specified in Clause 1, Article 6 of this Circular in cases where there are different naming conventions for the same active ingredient.

Article 9. Payment for drug loss expenses

1. Drug loss expenses shall be included in management costs to structure into the service fee for medical examination and treatment as prescribed in Article 119 of Decree No. 96/2023/ND-CP dated December 30, 2023 of the Government detailing some provisions of the Law on Medical Examination and Treatment (hereinafter referred to as Decree No. 96/2023/ND-CP).

2. In cases where drug loss expenses have not been included in management costs to structure into the technical service fee, payment shall be made as follows:

a) Drug loss expenses during storage, preservation, transportation, distribution, compounding, dosage division, and use of drugs shall be reimbursed by the health insurance fund according to the regulations stipulated in Circular No. 55/2017/TT-BYT dated December 29, 2017 of the Minister of Health regarding the rate of drug loss and the reimbursement of drug loss expenses at medical examination and treatment facilities.

b) The health insurance fund shall reimburse drug loss expenses annually as follows:

Drug loss expenses reimbursed by the health insurance fund = Rate of drug loss x Total health insurance payment cost for that drug.

Article 10. Payment for Drugs in Certain Specific Cases

The health insurance fund shall pay drug costs for insured patients who comply with the provisions of Articles 8 and 9 of this Circular, while also following certain specific regulations in the following cases:

1. For drugs in the form of different chemical isomers or salts of the active ingredient (including single-component and combination forms) listed in the drug list if they have the same indication as the chemical form or salt form of the drug listed in the drug list. For minerals listed in the drug list specifying the chemical isomer and salt form, the health insurance fund shall reimburse according to the specified chemical isomer and salt form in the drug list.

2. Drugs classified in this group but used to treat diseases in another group shall be reimbursed by the health insurance fund if they meet the appropriate indications as stipulated in Clause 3 of Article 8 of this Circular.

3. In cases where, based on professional indications, patients only use part of the quantity of drugs in the smallest unit package (for example: drugs used in pediatric specialties, oncology specialties) and the remaining quantity cannot be used (for example: there are no other patients with the same indication, the remaining quantity is insufficient for a dose, or it exceeds the drug's shelf life), the health insurance fund shall reimburse the entire amount according to the price of the smallest unit package.

4. In cases where certain liquid or compressed gas drugs (such as medicinal oxygen, nitric oxide) are not packaged for individual patient use or when used from equipment installed at medical examination and treatment facilities, the health insurance fund shall reimburse the quantity of drugs used based on the actual time spent breathing medical gases by the patient (x) the volume of gas breathed per unit of time (minutes or hours).

5. Chemical drugs and biological products marked with an asterisk (*) after the drug name in the drug list must be pre-discussed before use, except in emergency situations. For antibiotics marked with an asterisk (*), the health insurance fund shall reimburse when the prescription process complies with the guidelines for antibiotic use management in medical examination and treatment facilities issued by the Ministry of Health.

6. In cases where drugs have specified reimbursement rates or conditions noted in the remarks column of the drug list, the health insurance fund shall reimburse according to the specified reimbursement rate or condition. For drugs with reimbursement conditions based on medical examination and treatment facilities or specialized technical services in medical examination and treatment or professional requirements for drug use, the health insurance fund shall only reimburse when the medical examination and treatment facility uses the drug in compliance with the reimbursement conditions specified in the remarks column of the drug list.

Article 11. Payment for marking substances and radioactive drugs

1. For marking substances: Based on technical services and the number of patients directly receiving such technical services at healthcare facilities, the actual average usage rate of marking substance kits or bottles per technical service shall be calculated. The Health Insurance Fund will pay for marking substances according to the unit price of the marking substance multiplied by (x) the actual average usage rate.

2. For radioactive drugs: Based on the decay rate of radioactive drugs, supply sources, drug import cycles, and the actual patient flow using radioactive drugs at the facility, healthcare facilities shall determine the actual average usage rate of radioactive drugs. The Health Insurance Fund will pay for radioactive drugs according to the unit price multiplied by (x) the average dose used divided by (: ) the actual average usage rate of radioactive drugs.

3. The statistics and calculation of costs for technical services using radioactive drugs and marking substances are specified in Appendix 1 issued together with this Circular.

Article 12. Payment for cancer treatment drugs and immunomodulatory drugs

The Health Insurance Fund will pay for cancer treatment drugs and immunomodulatory drugs when they comply with the provisions of this Circular and meet the following conditions:

1. Used for cancer treatment upon prescription by a doctor authorized in oncology, nuclear medicine, hematology, or other specialties as prescribed by laws on medical examination and treatment; used at healthcare facilities with specialized departments for cancer treatment or approved by competent authorities to perform cancer treatment techniques and specialties as prescribed by laws on medical examination and treatment, except as provided in Clause 2 of this Article.

2. In cases where drugs are used to treat diseases other than cancer or for cancer and other diseases in non-oncology specialty departments: The Health Insurance Fund will pay when there is guidance on diagnosis and treatment from the Ministry of Health or the healthcare facility. If there is no guidance on diagnosis and treatment, a consultation must be held with an oncologist. If there is no guidance on diagnosis and treatment and no oncologist is available, a consultation must be conducted under the chairmanship of the healthcare facility's leadership before prescribing the use of the drug.

Article 13. Payment for drugs compounded or mixed at healthcare facilities

1. The Health Insurance Fund will pay for drugs compounded or mixed at healthcare facilities, including medicinal oxygen and nitric oxide, if they meet the following conditions:

a) Drugs compounded or mixed must have components listed in the drug list issued in accordance with this Circular. In cases where compounded or mixed drugs consist of multiple active ingredients, each component of the preparation must be included in the drug list issued in accordance with this Circular in either single or combined form. In cases where compounded or mixed drugs consist of multiple active ingredients but contain components not listed in the drug list issued in accordance with this Circular, follow the guidelines set out in Clause 4 of this Article;

b) Compliant with the route of administration and payment conditions in the drug list issued in accordance with this Circular;

c) Only used at that healthcare facility, except as provided in Clause 5 of this Article;

d) Costs for compounded or mixed drugs at healthcare facilities paid by the Health Insurance Fund shall not exceed the purchase price through competitive bidding for commercial drugs on the market with the same components, concentrations, and dosage forms as the compounded or mixed drugs.

2. Based on usage needs, healthcare facilities shall implement as follows:

a) For healthcare facilities under the Ministry of Health, healthcare facilities under ministries and sectors (except the Ministry of Public Security and the Ministry of National Defense), healthcare facilities under provincial health departments, and private healthcare facilities: The heads of these healthcare facilities are responsible for establishing compounding or mixing procedures, quality standards, and costs of drugs in accordance with Clause 3 of this Article and submitting them to social insurance agencies as the basis for payment;

b) For healthcare facilities within the people's armed forces system: Follow the guidance of the Ministry of Public Security and the Ministry of National Defense.

3. Drug costs are based on:

a) The cost of active ingredients of the drug according to the purchase price of the healthcare facility;

b) The cost of excipients, raw materials, packaging materials, and auxiliary materials for making drugs;

c) Loss costs (if any);

d) Sterilization costs (if any);

đ) Fuel and energy costs for processing and compounding, including electricity, water, and fuel;

e) Packaging material costs and consumable supplies;

g) Material, chemical, and auxiliary costs for quality control activities before testing;

h) Testing costs;

i) Labor costs for implementation;

k) Management costs and depreciation costs of equipment: For management costs and depreciation costs of equipment, the Health Insurance Fund will pay according to the adjustment process of factors constituting the price of medical examination and treatment services covered by health insurance as stipulated by competent authorities.

4. In cases where compounded or mixed drugs consist of multiple active ingredients but contain components not listed in the drug list issued with this Circular: The Health Insurance Fund will pay according to Clauses 1, 2, and 3 of this Article, excluding the cost of active ingredients not listed in the drug list issued in accordance with this Circular.

5. Healthcare facilities producing or mixing radioactive drugs, in addition to implementing the provisions of Clauses 1 and 2 of this Article, must also implement security measures to prevent loss of drugs and raw materials for radioactive drugs and obtain a permit from the Ministry of Science and Technology to conduct radiation work in accordance with laws on atomic energy. Drugs produced or mixed in accordance with this clause shall be supplied to other healthcare facilities in accordance with laws on pharmaceuticals.

Article 14. Payment for Medicines Used in Teleconsultation and Telemedicine Services

1. For medicines used in teleconsultation and telemedicine services:

a) Applies to teleconsultation and telemedicine services in accordance with the Law on Medical Examination and Treatment and Decree No. 96/2023/NĐ-CP;

b) The health insurance fund shall pay without being subject to the conditions for using medicines specified in the notes column of the medicine list issued together with Circular No. 20/2022/TT-BYT, provided that the following conditions are met:

- The prescriber or the person who orders the use of the medicine must meet the conditions for using the medicine specified in the notes column of the medicine list issued together with Circular No. 20/2022/TT-BYT (if applicable);

- The medicine must be purchased by the medical examination and treatment facility in accordance with the provisions of the law on bidding.

2. For medicines used in remote consultations:

a) Applies to patients receiving emergency treatment at a medical examination and treatment facility and using medicines according to professional guidance or treatment instructions given during a remote consultation with another medical examination and treatment facility;

b) The health insurance fund shall pay without being subject to the conditions for using medicines specified in the notes column of the medicine list issued together with Circular No. 20/2022/TT-BYT when the following requirements are met:

- The consultation must be conducted under a professional support contract or a technology transfer contract and must have a consultation record in accordance with the model prescribed in Appendix I issued together with Circular No. 49/2017/TT-BYT dated December 28, 2017, of the Minister of Health on remote healthcare activities;

- The medicine must be purchased by the medical examination and treatment facility in accordance with the provisions of the law on bidding.

Article 15. Payment in Cases of Group A Infectious Diseases

The health insurance fund shall pay for medicines in cases of Group A infectious diseases declared as epidemics under the law on prevention and control of infectious diseases when patients cannot reach the medical examination and treatment facilities where they were scheduled to receive treatment, specifically as follows:

1. In cases where patients are given appointment cards but due to the epidemic, they cannot reach the medical examination and treatment facility that issued the appointment card to receive treatment and medication, the medical examination and treatment facility or the patient may choose one or more of the following options:

a) The medical examination and treatment facility that issued the rescheduling appointment card transfers the medicine to another medical examination and treatment facility that the patient can reach for continued treatment and provision of medicine. The health insurance fund shall pay the cost of the medicine for the patient to the medical examination and treatment facility that receives the medicine based on the purchase price of the medical examination and treatment facility that transferred the medicine within the scope of insurance benefits;

b) Patients may authorize a representative to collect the medicine from the medical examination and treatment facility that issued the rescheduling appointment card or from another medical examination and treatment facility (where the medicine is received from the issuing facility).

- The authorization must be in writing, clearly stating the full name, date of birth, identification number, or other valid personal identification information of both the patient and the authorized person to collect the medicine. When collecting the medicine, the authorized person must present appropriate identification documents matching the information recorded in the authorization letter;

- Medical examination and treatment facilities are responsible for verifying the accuracy of the information recorded on the authorization letter against the identification documents presented by the authorized person to collect the medicine at the medical examination and treatment facility;

c) For patients with tuberculosis, latent tuberculosis, drug-resistant tuberculosis, or HIV/AIDS and non-infectious diseases, the medical examination and treatment facility that issued the rescheduling appointment card dispatches personnel or through a third party to deliver the medicine to the patient for continued treatment and use.

2. In cases where patients are undergoing inpatient treatment at medical examination and treatment facilities assigned to prevent and control the epidemic, and due to the epidemic situation, the patients cannot be transferred to another facility and the medical examination and treatment facility does not have the necessary medicine available at the time of prescription or instruction, the medical examination and treatment facility may apply the following measures:

a) Apply the regulations on transferring medicines between medical examination and treatment facilities as stipulated by law;

b) Be reimbursed for the cost of medicines used for patients when the medicines are purchased by the medical examination and treatment facility in accordance with the provisions of the law on bidding, regardless of the type of medical examination and treatment facility, including medicines with conditions regarding the scope of professional and specialized activities of medical examination and treatment facilities specified in the notes column of the medicine list issued together with Circular No. 20/2022/TT-BYT.

Article 16. Certain cases for drug payment at commune health stations

1. The Health Insurance Fund shall pay for drugs for insured persons managed for chronic diseases at commune health stations as follows:

a) The commune health station examines, prescribes, and distributes drugs within the scope of professional activities and technical services approved by competent authorities;

b) Drugs are distributed by the commune health station based on prescriptions from healthcare facilities providing higher-level technical services.

2. In cases where commune health stations have medical practitioners dispatched, rotated, or supported with specialized technical guidance from higher-level technical facilities according to the assignment or plan of competent authorities or under contracts; in cases of technology transfer under contracts; or in cases of remote diagnosis and treatment or support for remote diagnosis and treatment as prescribed by laws on diagnosis and treatment:

The Health Insurance Fund shall pay for drugs commensurate with the capabilities and scope of specialization of the dispatched, rotating, guiding, supporting, transferring, remotely diagnosing, treating, or supporting remote diagnosis and treatment medical practitioners, and in accordance with the diagnostic and treatment guidelines issued by the Ministry of Health.

Article 17. Guidance on drug distribution for chronic disease treatment when patients are undergoing inpatient treatment for other illnesses

In cases where patients who are receiving outpatient treatment for chronic diseases must be admitted for inpatient treatment for other illnesses, during the inpatient treatment period if they run out of drugs for their chronic diseases, the Health Insurance Fund shall pay as follows:

1. In cases where the inpatient facility is the same as the outpatient facility where the patient is being treated for chronic diseases:

a) Patients may continue to receive drugs at the outpatient chronic disease department or at the inpatient department if the inpatient physician has the qualifications to prescribe drugs for chronic diseases;

b) If the inpatient physician does not have the qualifications to prescribe drugs for chronic diseases, they must consult with the outpatient chronic disease department physician to prescribe drugs for chronic diseases for the patient. The treatment regimen and quantity of drugs for chronic diseases shall be recorded in the medical record, outpatient card, and dispensed together with inpatient treatment drugs.

2. In cases where the inpatient facility is different from the outpatient facility where the patient is being treated for chronic diseases:

a) If the inpatient facility has the scope of specialization to treat the chronic disease that the patient is being treated for, the patient may receive drugs at this facility.

The patient must present the outpatient card clearly indicating the treatment regimen and the quantity of drugs already provided as the basis for subsequent drug issuance. The inpatient department physician shall prescribe drugs for chronic diseases if they have the qualifications to do so. If the inpatient department physician does not have the qualifications to prescribe drugs for chronic diseases, they must consult with a physician who has the qualifications to prescribe drugs for chronic diseases to prescribe drugs for the patient. The treatment regimen and quantity of drugs for chronic diseases shall be recorded in the medical record, outpatient card, and dispensed together with inpatient treatment drugs;

b) If the inpatient facility does not have the scope of specialization to treat the chronic disease that the patient is being treated for, the patient's representative shall collect drugs at the outpatient facility where the patient is being treated for chronic diseases. When collecting drugs, the patient's representative must present personal identification documents (ID card, citizen identity card, passport, or other valid personal identification documents) and a certificate of inpatient treatment according to the form specified in Appendix 2 attached to this Circular.

Article 18. Medicines to be reimbursed in special cases

Special medicines serving political tasks, urgent needs in disease prevention and control, war, natural disasters, and national-level catastrophes shall not apply the provisions of Articles 3, 4, and 5 of this Circular. The Ministry of Health shall consider issuing guidelines for health insurance reimbursement based on the political tasks directly assigned by the Party, State, and Government to the Ministry of Health in emergency situations.

Chapter V
IMPLEMENTING PROVISIONS

Article 19. Implementation

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

a) Organizing the implementation and guiding the execution of this Circular;

b) Study and propose updates, adjustments, modifications, and supplements to principles and criteria to meet treatment needs and align with the payment capacity of the health insurance fund;

c) Receive, compile, study, and evaluate proposals for modifying and updating the drug list from healthcare facilities, pharmaceutical businesses, and relevant agencies, organizations, and individuals; seek opinions from specialized councils, organizations, and experts regarding safety, efficacy, and economic evaluation of proposed drugs when necessary for building and updating the drug list;

d) Organize reviews to submit to the Minister of Health for updating the drug list to ensure appropriateness and meet treatment needs and the benefits of health insurance participants at least once every two years;

đ) Study, develop, and update professional guidance on pharmacoeconomic reports to provide information during the process of building and updating the drug list;

e) Serve as the lead coordinator with related agencies to review and consider medical and pharmaceutical associations and societies with credibility as references for recommendations to build and update the drug list;

g) Submit to the Minister of Health for establishing a specialized council consisting of experts with appropriate qualifications and experience to advise on evaluating applications and related professional issues concerning the drug list and the safety, efficacy, and costs of drugs;

h) Lead and coordinate with related agencies to resolve any difficulties arising during implementation;

2. Other Departments, Bureaus, units under the Ministry of Health, and the National Center for Drug Information and Adverse Event Monitoring (National DI & ADR Center) shall have the responsibility to cooperate in implementing this Circular according to their functions, duties, and authorities;

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

b) Reviewing, screening, and assessing practical needs and compiling recommendations from medical examination and treatment facilities within their jurisdiction to propose the Ministry of Health to amend and supplement the health insurance medicine list;

b) Review, examine, assess practical needs, and consolidate recommendations from healthcare facilities within their jurisdiction to propose the Ministry of Health to supplement or modify the drug list;

a) Providing complete and timely information and data related to health insurance reimbursement for medical examination and treatment costs to the Ministry of Health for review during the process of building and updating the medicine list;

a) Provide complete and timely information and data related to health insurance reimbursement for medical examination and treatment to review applications during the process of building and updating the drug list;

5. Medical examination and treatment facilities shall be responsible for:

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 chemical drugs, biological products, radioactive drugs, and labeling substances used at the unit, including self-manufactured or compounded drugs (if any), and send it to the social insurance agency where the health insurance examination and treatment contract is signed along with the tender selection plan, tender selection results, compounding procedures, quality standards, prices, or costs of compounded drugs for the basis of health insurance reimbursement for medical examination and treatment expenses;

b) In case of changes or additions to the drug list used at the unit, healthcare facility, send the modified or supplemented drug list to the social insurance agency where the health insurance examination and treatment contract is signed for reimbursement purposes;

c) Review drug usage, assess drug demand at the facility, and propose adding or removing drugs from the list, then send the proposal to the Department of Health Insurance, Ministry of Health (for healthcare facilities under the Ministry of Health and other ministries) or the Department of Health of provinces and centrally-administered cities (for healthcare facilities under provincial departments of health);

d) Ensure the scientific accuracy of information related to the drug list and compliance with the Ministry of Health's professional guidelines;

6. Pharmaceutical production facilities, drug registration facilities, drug import facilities, and drug distribution facilities shall have the responsibility to provide drug information managed by their facility when needed for adjustment or supplementation and ensure the scientific accuracy of the proposed information related to the drug list and compliance with the Ministry of Health's professional guidelines;

Article 20. Implementation Provisions

1. This Circular shall take effect from January 1, 2025.

2. The provisions of Article 7 of this Circular shall not apply to health insurance reimbursement for medical examination and treatment costs until the Minister of Health issues new regulations on the drug list and reimbursement ratios and conditions for chemical drugs, biological products, radioactive drugs, and labeling substances within the scope of health insurance coverage;

3. Amend some provisions in point d, Clause 1, Article 2 of Circular No. 20/2022/TT-BYT as follows:

a) Amend the phrase "has been classified by competent state authorities as equivalent to Level III" in paragraph 3 to "had been classified by competent state authorities as equivalent to Level III before January 1, 2025";

b) Amend the phrase "has not been classified by competent state authorities" in paragraph 4 to "had not been classified by competent state authorities before January 1, 2025";

4. Articles 3, 4, 5, and 6 of Circular No. 20/2022/TT-BYT shall cease to be effective from the date this Circular takes effect;

5. In cases where patients enter healthcare facilities for examination and treatment before the date this Circular takes effect but conclude treatment after the date this Circular takes effect, the provisions of this Circular shall apply;

Article 21. 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 implementation, if there are difficulties, please report them to the Ministry of Health (Department of Health Insurance) for consideration and resolution./.

 

ANNEX 1

MODEL FOR STATING RADIOACTIVE DRUGS AND LABELING SUBSTANCES USED IN TECHNICAL SERVICES
(Annexed to Circular No. 37/2024/TT-BYT dated November 16, 2024 issued by the Minister of Health)

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HEALTHCARE FACILITY...

Note:

- Column (1): Service number.

- Column (2): Name of technical service using radioactive drugs and marker substances.

- Column (3): Price of the technical service excluding costs of radioactive drugs and marker substances, approved by competent authority.

- From column (4) to column (9): Indicators for calculating costs of marker substances used in technical services, including:

+ Column (4): Name of marker substance.

+ Column (5): Record unit of measurement (kit or bottle).

+ Column (6): Record unit price of marker substance.

+ Column (7): Manufacturer's usage rate: Record usage rate specified by manufacturer for marker substance for each technical service.

+ Column (8): Actual average usage rate:

Note: Healthcare facility calculates actual average usage rate of marker substance kits for each technical service based on the technique of the technical service and the number of patients directly receiving the technical service at the healthcare facility. For example, for SPECT myocardial perfusion imaging at rest using the marker substance Methoxyisobutyl isonitrile (MIBI), each kit of MIBI can be used for 4 patients, thus the usage rate is 1/4. The healthcare facility records this figure in column 8 for the SPECT myocardial perfusion imaging at rest technical service.

- Column (9): Total amount of column (9) equals the amount of column (6) multiplied by (x) the amount of column (8).

- From column (10) to column (15): Indicators for calculating costs of radioactive drugs used in technical services, including:

+ Column (10): Record name of radioactive drug.

+ Column (11): Record unit of measurement of radioactive drug.

+ Column (12): Record unit price of radioactive drug (based on purchase price of healthcare facility).

+ Column (13): Record average dose of radioactive drug used in technical service.

+ Column (14): Record average actual usage rate of radioactive drug. Healthcare facility establishes average actual usage rate of radioactive drug based on radioactive decay rate, supply of radioactive material, radioactive material replenishment cycle, and actual patient flow using radioactive drugs at the healthcare facility.

Example: For I-131, based on half-life T1/2 of 8 days, if the healthcare facility replenishes every 15 days, then on the first day the usage rate of radioactive drug is 100%, but after 8 days the usage rate of radioactive drug is 50% (due to 50% decay), and after 16 days the usage rate of radioactive drug is 25% (as the remaining 50% decays another 50%). Based on the number of patients using the drug, the healthcare facility determines the actual average usage rate of I-131 to be 50%, which will be recorded in column (14) corresponding to I-131 as 50%.

+ Column (15): Cost of radioactive material = column (12) x column (13): column (14).

- Column (16): Total cost of technical service price including both radioactive drug and marker substance costs equals the amount of column (3) plus (+) the amount of column (9) plus (+) the amount of column (15)./

 

ANNEX 2

INPATIENT TREATMENT CERTIFICATE FORM
(Annexed to Circular No. 37/2024/TT-BYT dated November 16, 2024 issued by the Minister of Health)

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INPATIENT TREATMENT CERTIFICATE

Patient's Full Name …

Gender …

Date of Birth …

Health Insurance Card Number …

Diagnosis …

Currently undergoing inpatient treatment in Department: …

 

 

¹ Head of Unit or person authorized by the Head of Unit to sign and stamp.