Circular No. 20/2022/TT-BYT promulgates the List and payment ratios, conditions for chemical drugs, biological products, radioactive drugs, and markers within the scope of health insurance beneficiaries.

CIRCULAR

Issuing the List and Payment Ratio and Conditions for Chemical Drugs, Biological Products, Radioactive Medicines, and Markers within the Scope of Coverage for Health Insurance Participants

                                          

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

Pursuant to the Government Decree No. 146/2018/NĐ-CP dated October 17, 2018 detailing and guiding the implementation of certain provisions of the Health Insurance Law;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the 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 on issuing the List and Payment Ratio and Conditions for Chemical Drugs, Biological Products, Radioactive Medicines, and Markers within the Scope of Coverage for Health Insurance Participants.

Article 1. The List issued together with this Circular

1. The List of chemical drugs and biological products within the scope of coverage for health insurance participants is specified in Appendix I attached hereto (hereinafter referred to as Appendix I).

2. The List of radioactive medicines and markers within the scope of coverage for health insurance participants is specified in Appendix II attached hereto (hereinafter referred to as Appendix II).

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

1. The List of chemical drugs and biological products in Appendix I is arranged into groups according to therapeutic effects, divided into eight (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 medicine. The name of the medicine is recorded according to the generic name according to the International Non-proprietary Name (INN). In cases where there is no International Non-proprietary Name, it is recorded according to the active ingredient approved for circulation or the name in the Ministry of Health's diagnostic and treatment guidelines. Medicines are arranged into major groups according to the Anatomical Therapeutic Chemical (ATC) code;

c) Column 3: Records the route of administration and form of use of the medicine; does not record the dosage; does not specify the specific preparation form, except for some preparation forms that have clear differences in efficacy and therapeutic effect. The route of administration and form of use of chemical drugs and biological products in the List are understood and unified as follows:

- Oral includes oral, chewable, and lozenges;

- Injection includes intramuscular, subcutaneous, intradermal, intravenous, infusion, intravenous infusion, intra-articular, intraocular, intravitreal, and intracavitary injections;

- External use includes topical creams, lotions, patches, sprays, washes, and applications to mucous membranes;

- Insertion includes vaginal, rectal, enema, and sublingual insertions;

- Inhalation includes aerosols, inhalations (solutions, suspensions, powders for inhalation), nebulizations;

- Eye drops include eye drops and eye ointments; ear drops include ear drops; nasal drops include nasal drops and nasal sprays;

- Other routes of administration and forms of use are specifically recorded in the List for some medicines with special routes of administration and forms of use;

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

- Class II hospitals use medicines specified in Column 5;

- Class III and Class IV hospitals, including multi-disciplinary clinics under general hospitals or under district health centers, multi-disciplinary clinics, private midwifery clinics that have been authorized by competent authorities to perform equivalent tertiary-level specialized technical procedures use medicines specified in Column 6;

- Multi-disciplinary clinics, specialized clinics, private midwifery clinics that have not been assigned specialized technical levels; commune health stations, urban health stations, health stations of enterprises and equivalent institutions (hereinafter collectively referred to as commune health stations) use medicines specified in Column 7;

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

2. The List of radioactive medicines and markers in the medicine list specified in Appendix II includes five (5) columns:

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

b) Column 2: Records the name of the medicine. The name of the medicine is recorded according to the International Non-proprietary Name (INN). In cases where there is no name according to the INN, it is recorded according to the active ingredient 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: Records the unit of use of the medicine. Radioactive medicines and markers in the medicine list specified in Appendix II are not classified by hospital level and can only be used at medical facilities authorized by competent authorities to perform diagnosis and treatment using radioactive medicines and markers.

1. The Health Insurance Fund shall reimburse medication costs based on the actual quantity used by patients, except in cases stipulated in Clause 5, Article 5 of this Circular; the purchase price of the medical facilities must comply with the legal provisions on bidding and be consistent with the scope of benefits and entitlement levels under the health insurance laws.

2. The Health Insurance Fund shall reimburse medication costs when the prescription is appropriate according to 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.

3. The Health Insurance Fund shall not reimburse in the following cases:

a) Medications or batches of medications that have been decided to be withdrawn from circulation or recalled. The non-reimbursement of such medications or batches of medications shall apply within the scope specified in the announcement or decision on withdrawing from circulation or recalling these medications or batches of medications issued by the Ministry of Health.

b) Costs of medications that have been incorporated into the prices of technical services, outpatient visits, hospital bed days, or bundled package prices per case as currently regulated.

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.

The Health Insurance Fund shall reimburse medication costs for certain medical examination and treatment facilities in compliance with the provisions of Article 3 and Article 5 of this Circular, while adhering to specific regulations in particular circumstances as follows:

1. For state-owned medical examination and treatment facilities that have signed health insurance medical examination and treatment contracts but have not yet been classified as hospitals: Based on human resources, medical equipment, infrastructure, and the list of technical services approved by the competent authority, the Department of Health shall take the lead and coordinate with the Social Security Office of the province to determine in writing the use of medications at this medical examination and treatment facility according to the appropriate hospital classification.

2. For state-owned medical examination and treatment facilities under the people's armed forces that have signed health insurance medical examination and treatment contracts but have not yet been classified as hospitals: Based on human resources, medical equipment, infrastructure, and the list of technical services approved by the competent authority, the direct management agency of the medical examination and treatment facility shall take the lead and coordinate with the Department of Health and the social security agency where the health insurance medical examination and treatment contract was signed to determine in writing the list of medications reimbursed by the Health Insurance Fund at this medical examination and treatment facility according to the appropriate hospital classification.

3. In cases where medical examination and treatment facilities implement technical services approved by the competent authority, they may use medications to perform those services (including medications prescribed at higher hospital classifications). The medical examination and treatment facility shall compile and submit the list of medications to the social security agency where the health insurance medical examination and treatment contract was signed as the basis for reimbursement.

4. In cases where provincial specialized medical examination and treatment facilities use medications not accompanied by technical services, based on human resources, medical equipment, infrastructure, treatment needs at the medical examination and treatment facility, and the diagnostic and treatment guidelines of the Ministry of Health, the Department of Health shall take the lead and coordinate with the Social Security Office of the province to determine in writing the list of medications exceeding the classification that the Health Insurance Fund will reimburse at this medical examination and treatment facility (including medications with conditions regarding classification and specialty of medical examination and treatment facilities listed in Column 8 of the List of Medications in Appendix I) but not exceeding the highest classification of a provincial general hospital located in the area.

The Health Insurance Fund shall pay the cost of medicines for insured patients who comply with the provisions of Articles 3 and 4 of this Circular, while also following specific regulations in the following cases:

1. Different chemical isomers or different salt forms of active ingredients (including single-component and multi-component combination forms, except vitamins and minerals) listed in Appendix I to this Circular shall be reimbursed by the Health Insurance Fund if they have the same indication as the chemical form or medicine listed in the Medicine List.

2. Medicines belonging to a 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 2 of Article 3 of this Circular.

3. Certain medicines with specified payment conditions and ratios shall be reimbursed by the Health Insurance Fund according to the provisions in Column 8 of the Medicine List set out in Appendix I.

4. In cases where, based on professional prescription, patients only use part of the quantity of medicine in the smallest unit package (for example, medicines used in pediatric specialties, oncology specialties) and the remaining quantity cannot be used (for example, there is no other patient with the same indication, the remaining quantity is insufficient for dosage, or it has exceeded the storage period of the medicine), the Health Insurance Fund shall reimburse the full amount according to the price of the smallest unit package.

5. For liquid or compressed gas medicines (such as medicinal oxygen, nitric oxide) that are not packaged for individual patient use, the Health Insurance Fund shall reimburse the quantity of medicine used based on the actual time of medical gas inhalation by the patient (x) the volume of gas inhaled per unit of time (minutes or hours).

6. Regarding markers and radioactive drugs:

a) For markers: Based on technical services and the number of patients directly receiving such technical services at the facility, the healthcare facility calculates the average actual usage rate of marker kits or bottles for each technical service. The Health Insurance Fund shall reimburse the cost of markers according to the unit price of the marker multiplied by (x) the average actual usage rate;

b) For radioactive drugs: Based on the decay rate of radioactive drugs, supply sources, import cycles, and the actual patient flow using radioactive drugs at the facility, the healthcare facility determines the average actual usage rate of radioactive drugs. The Health Insurance Fund shall reimburse the cost of radioactive drugs according to the unit price multiplied by (x) the average dose used divided by (: ) the average actual usage rate of radioactive drugs;

c) The statistics and calculation of costs for technical services using radioactive drugs and markers are regulated in Appendix III issued together with this Circular.

7. Medicines marked with an asterisk (*) 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 follows the guidelines for managing antibiotic use in hospitals as prescribed by the Ministry of Health.

8. For cancer treatment medicines and immunomodulatory medicines:

a) Used for cancer treatment when prescribed by a doctor licensed to practice medicine and whose scope of practice includes oncology or nuclear medicine or blood transfusion and who uses them at healthcare facilities with cancer treatment functions, except in cases provided for in point b of this clause, including: - Cancer centers, blood transfusion centers, nuclear medicine centers; - Oncology, blood transfusion, and nuclear medicine departments or centers within specialized hospitals or general hospitals; - Organizations with the responsibility for cancer treatment as defined in their operational regulations or organizational charters approved or recognized by competent authorities.

b) When used to treat other diseases that are not cancer: The Health Insurance Fund shall reimburse when there are diagnostic and treatment guidelines from the Ministry of Health or the healthcare facility. If 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 leadership of the healthcare facility's management must be conducted before prescribing the use.

9. For medicines compounded or mixed (including medicinal oxygen and nitric oxide) at healthcare facilities:

a) Reimbursable by the Health Insurance Fund when: - The compounded or mixed medicines must contain components listed in the Medicine List issued with this Circular. In cases where compounded or mixed medicines consist of multiple active ingredients, each component of the preparation must be listed in the Medicine List issued with this Circular as either a single substance or a combination form. In cases where compounded or mixed medicines consist of multiple active ingredients, but some components are not listed in the Medicine List issued with this Circular, the guidance provided in point d of this clause shall apply; - They must be consistent with the route of administration, form, and hospital category specified in the Medicine List issued with this Circular; - They can only be used at that healthcare facility.

b) Based on usage needs, healthcare facilities shall act as follows: - For healthcare facilities under the Ministry of Health: The head of the healthcare facility is responsible for developing compounding or mixing procedures, quality standards, prices, or costs of medicines; reaching agreement with the social insurance agency on the prices or costs of medicines as the basis for reimbursement; - For healthcare facilities under the People's Armed Forces: Follow the guidelines of the Ministry of Public Security and the Ministry of National Defense; - For healthcare facilities under the Department of Health and private healthcare facilities, follow the legal regulations on pricing.

c) The price or cost of the medicine is established on the basis of: - The cost of active ingredients of the medicine according to the purchase price of the medical examination and treatment facility; - Loss costs (if any); - Excipient and auxiliary material costs for making the medicine; - Sterilization costs (if any); - Processing and compounding costs including electricity, water, fuel; - Packaging material and consumable costs; - Quality control material, chemical, and auxiliary costs before testing; - Testing costs; - Labor costs for implementation; - Management costs and depreciation costs of machinery: For management costs and depreciation costs of machinery, the health insurance fund pays according to the adjustment schedule of factors constituting the service price of medical examination and treatment under health insurance issued by the Minister of Health and applied simultaneously with the service price of medical examination and treatment under health insurance between hospitals of the same level nationwide.

d) In cases where the compounded medicine consists of multiple active ingredients, but some components are not included in the list of medicines issued together with this Circular: The health insurance fund pays according to the provisions of points a, b, and c of this clause, excluding the cost of active ingredients not included in the list of medicines issued together with this Circular.

đ) The health insurance fund does not pay for compounded or mixed medicines when there are commercial medicines available on the market with the same composition, dosage form, and purchase price through bidding is lower than the price or cost of compounded or mixed medicines at the medical examination and treatment facility.

10. Regarding 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 prescriptions during remote consultations with another medical examination and treatment facility.

b) The health insurance fund pays without regard to the hospital level as stipulated in this Circular (including medicines with conditions regarding hospital level and specialty specified in column 8 of the Medicine List prescribed in Appendix I) if the following requirements are met: - The consultation is conducted according to the directive line task or technical transfer contract; - The medicines purchased by the medical examination and treatment facility treating the patient are procured in accordance with the law on bidding; - There is a consultation record in accordance with the model consultation record implemented according to Appendix I issued along with Circular No. 49/2017/TT-BYT dated December 28, 2017, by the Minister of Health on remote healthcare activities.

11. In cases of Group A infectious diseases, where patients cannot reach a medical examination and treatment facility, the health insurance fund pays as follows:

a) In cases where patients are given an appointment for a follow-up visit but due to the epidemic, they cannot reach the medical examination and treatment facility that issued the appointment for medical examination and treatment and medication collection, the medical examination and treatment facility or the patient may choose one or more of the following options: - The medical examination and treatment facility issuing the follow-up appointment transfers medicines to another medical examination and treatment facility that the patient can reach for continued treatment and medication provision. The health insurance fund pays the cost of medicines for the patient's treatment provided by the medical examination and treatment facility.

b) In cases where patients undergoing inpatient treatment have been prescribed a transfer but due to the epidemic situation, the patient cannot be transferred, the health insurance fund pays the cost of medicines used for the patient when these medicines are procured by the medical examination and treatment facility in accordance with the law on bidding, regardless of the hospital level stipulated in this Circular, including medicines with conditions regarding hospital level and specialty specified in column 8 of the Medicine List prescribed in Appendix I.

1. The Department of Health Insurance - Ministry of Health shall be responsible for directing, guiding, disseminating, inspecting, evaluating, summarizing, and concluding the implementation of this Circular throughout the country.

2. Vietnam Social Security shall be responsible for:

a) Directing, guiding, and inspecting the implementation of this Circular by social security agencies of provinces and centrally-administered cities;

b) Directing social security agencies of provinces and centrally-administered cities to unify with medical examination and treatment facilities on the price or cost of compounded or mixed medicines at medical examination and treatment facilities as the basis for paying medical examination and treatment costs under health insurance.

3. Provincial Departments of Health shall be responsible for directing, guiding, disseminating, inspecting, evaluating, summarizing, and concluding the implementation of this Circular within their jurisdiction.

4. Healthcare facilities shall be responsible for:

a) Establishing a list of chemical drugs, biological products, radioactive medicines, and labeling substances used at the unit, including medicines compounded or mixed by the medical examination and treatment facility (if any), and sending it to the social security agency where the medical examination and treatment contract under health insurance is signed, accompanied by the tender selection plan, tender selection results, compounding or mixing procedures, quality standards, and the price or cost of compounded or mixed medicines at the medical examination and treatment facility as the basis for paying medical examination and treatment costs under health insurance;

b) In cases of changes or additions to the list of medicines used at the unit, the medical examination and treatment facility sends the revised or supplemented list of medicines to the social security agency where the medical examination and treatment contract under health insurance is signed as the basis for payment;

c) In cases where the medical examination and treatment facility is unable to continue providing approved medical services and medicines, the medical examination and treatment facility has the responsibility to report to the competent authority and the social security agency where the medical examination and treatment contract under health insurance is signed to stop the provision of medical services, use of medicines, and health insurance payments.

Article 7. Effective Date

1. This Circular takes effect from March 1, 2023.

2. Circular No. 30/2018/TT-BYT dated October 30, 2018, issued by the Minister of Health on the List and Proportions, Conditions for Payment for Chemical Drugs, Biological Products, Radioactive Medicines, and Markers within the Scope of Coverage for Health Insurance Beneficiaries; Circular No. 01/2020/TT-BYT dated January 16, 2020, issued by the Minister of Health amending and supplementing Circular No. 30/2018/TT-BYT; Circular No. 20/2020/TT-BYT dated November 26, 2020, issued by the Minister of Health amending and supplementing certain provisions of Circular No. 30/2018/TT-BYT shall cease to be effective from the date this Circular takes effect.

Article 8. Transitional Provisions

1. In cases where patients with health insurance cards enter inpatient treatment before the date this Circular takes effect and must continue their treatment at healthcare facilities after the date this Circular takes effect, the provisions of this Circular shall apply to the entire inpatient treatment period of such patients.

2. For patients with cancer who have been using doxorubicin, injectable form, liposomal; erlotinib, oral; gefitinib, oral; sorafenib, oral (for advanced hepatocellular carcinoma and renal cell carcinoma) prior to January 1, 2015 and continue to use these drugs after the date this Circular takes effect, they will continue to be reimbursed at a rate of 100%. For patients with cancer who have been using everolimus, injectable and oral; L-asparaginase erwinia, injectable; paclitaxel, injectable, liposomal and polymeric micelle forms prior to January 1, 2019 and continue to use these drugs after the date this Circular takes effect; or sorafenib, oral (for advanced renal cell carcinoma) after January 1, 2015 and continue to use it after the date this Circular takes effect, they will continue to be reimbursed according to the rates specified in Circular No. 40/2014/TT-BYT dated November 17, 2014, issued by the Minister of Health on the Implementation Guidelines for the List of New Chemical Drugs within the Scope of Reimbursement by the Health Insurance Fund. This provision applies in the following situations:

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

b) After treatment at a healthcare facility, if the patient transfers to another healthcare facility and is prescribed the same drug by a doctor but still within the treatment course (except in cases of outpatient treatment outside the designated facility);

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 the patient experiences side effects from taking erlotinib, oral, or the healthcare facility runs out of the drug, and the doctor prescribes switching to gefitinib, oral, and vice versa (switching from gefitinib, oral to erlotinib, oral);

Article 9. Cross-References

Where the referenced documents in this Circular are replaced or amended, the provisions 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.

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./.