Circular No. 40/2014/TT-BYT Issuing and guiding the implementation of the List of New Drugs within the scope of payment by the Health Insurance Fund

CIRCULAR

Issuing and guiding the implementation of the List of New Drugs

thuộc phạm vi thanh toán của quỹ bảo hiểm y tế

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Pursuant to the Health Insurance Law number 25/2008/QH12 dated November 14, 2008, and the Law Amending and Supplementing Certain Provisions of the Health Insurance Law number 46/2014/QH13 dated June 13, 2014;

On the basis of Decree Decision number 63/2012/NĐ-CP dated August 31, 2012 of At the proposal of qetermining on the functions, tasks, powers, and organizational structure of the Ministry of Health;

and cryptographic personnel

The Minister of Health issues this Circular on issuing and guiding the implementation of the list of new drugs within the scope of payment by the health insurance fund.

Article 1. List of New Drugs

1. Attached to this Circular is the list of new drugs within the scope of payment by the health insurance fund, including: 845 active ingredients, 1064 new drugs; 57 radioactive drugs and labeled compounds.

2. The list of new drugs attached to this Circular serves as the basis for the health insurance fund to pay for drug costs used for patients with health insurance cards at medical examination and treatment facilities.

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

1. The list of new drugs:

a) Drugs or active ingredients are arranged into 27 major groups according to the ATC code (anatomical, therapeutic, chemical). Some drugs or active ingredients with multiple ATC codes and different indications are classified into the most appropriate group to minimize overlap;

b) Drug or active ingredient names are recorded according to the International Nonproprietary Name and the provisions of the National Pharmacopoeia of Vietnam, only recording the route of administration and form, without recording the dosage.

2. The routes of administration listed in the directory are unified as follows:

a) Oral route includes oral, sublingual, chewable, and buccal medications;

b) Parenteral route includes intramuscular, subcutaneous, intradermal, intravenous, intravenous infusion, intra-articular, intraocular, intracameral, and intracavitary injections;

c) Topical route includes topical creams, lotions, patches, and sprays;

d) Insertion route includes vaginal, rectal, and enema suppositories;

đ) Respiratory route includes nebulizers, inhalers, dry powder inhalers, sprays, and aerosols;

e) Ophthalmic route includes eye drops and ointments.

3. New drugs and active ingredients in the list of new drugs are used at medical examination and treatment facilities according to hospital classification levels, specifically as follows:

a) Special class and Class I hospitals use drugs specified in column 5;

b) Class II hospitals use drugs specified in column 6;

c) Class III and Class IV hospitals, including community health centers under general hospitals or district, county, town, or city health centers, use drugs specified in column 7;

d) Medical examination and treatment facilities such as commune, ward, town, or equivalent health stations use drugs specified in column 8;

đ) For medical examination and treatment facilities that have signed health insurance contracts but have not been classified as hospitals: Based on their professional capacity, medical equipment, and approved technical service directories, the Department of Health shall take the lead and coordinate with social insurance organizations to determine the appropriate hospital level for these facilities based on equivalency with state-run medical examination and treatment facilities.

4. The list of radioactive drugs and labeled compounds is recorded according to the International Nonproprietary Name, not classified by hospital levels, and can only be used at nuclear medicine facilities, cancer hospitals, cancer centers, nuclear medicine departments, oncology departments, or radiation therapy departments in general or specialized hospitals.

Article 3. Construction of the list of drugs within the scope of health insurance fund payment for use at medical examination and treatment facilities

1. Based on the drug list and hospital classification as prescribed in this Circular; based on the hospital level approved by the competent authority; treatment needs and the health insurance fund's payment capacity, medical examination and treatment facilities shall construct the drug list for procurement in accordance with the legal provisions on bidding.

2. The selection of finished drugs for procurement and use for patients shall follow the principle of prioritizing generic drugs, single-component drugs, and domestically produced drugs.

Article 4. General principles for health insurance fund payment for drug costs for insured patients

1. The health insurance fund shall pay for drug costs based on the actual quantity used for patients and the purchase price of medical examination and treatment facilities in accordance with the legal provisions on drug bidding, consistent with the scope of benefits and entitlement levels stipulated in the Health Insurance Law, the Law Amending and Supplementing Certain Provisions of the Health Insurance Law, and guiding documents.

2. The health insurance fund shall not pay for the following cases:

a) Costs of drugs that have been incorporated into the technical service fee, the daily bed charge (for example, anesthesia, sedation, infusion drugs used during surgery, procedures, or contrast agents used in imaging diagnosis, antiseptic and disinfectant drugs) or the package fee charged per case according to current regulations;

b) The portion of costs for drugs included in the list that have been paid for by the state budget;

c) Drugs included in the list used in clinical trials and scientific research;

d) Drugs or batches of drugs that have been suspended from circulation and recalled by the competent authority;

đ) Using drugs that are not appropriate with the indications registered in the approved drug registration dossier.

Article 5. Payment provisions for certain types of drugs

1. Other forms of chemical isomers or other salt forms of active ingredients listed in the drug list shall be reimbursed by the health insurance fund if they have the same therapeutic effect as the chemical form or drug name listed in the drug list.

2. Drugs classified in one group but used to treat diseases in another group shall be reimbursed by the health insurance fund if they are indicated as registered in the approved drug registration dossier.

3. Some drugs with specified conditions and reimbursement rates shall be reimbursed according to the provisions in column 9 of the list of new drugs and in accordance with the general principles stipulated in Clause 1, Article 4 of this Circular.

4. Drugs containing multiple active ingredients that are not specified in the list shall be reimbursed by the health insurance fund if all active ingredients are listed individually (except vitamins and minerals) and have the same route of administration as stipulated in Clause 2, Article 2 of this Circular. Combined drugs must ensure safe, effective, and appropriate use with the health insurance fund's payment capacity.

In cases where combined drugs contain active ingredients with different hospital classifications, payment shall be made according to the highest hospital classification. If combined drugs have different reimbursement rates, payment shall be made according to the lowest rate.

5. In cases where, according to specialized instructions, patients only use part of the quantity of drugs in the smallest unit packaging (for example, drugs used in pediatric or 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, or it has exceeded the storage period), the health insurance fund shall reimburse the entire amount based on the price of the smallest unit packaging.

6. Drugs marked with an asterisk (*) are only to be used when other drugs in the treatment group are ineffective and must be reviewed before use. In emergency situations, the review must be conducted no later than the next working day.

7. For drugs in the cancer treatment group:

a) They can only be used for cancer treatment at medical examination and treatment facilities with cancer treatment functions (including cancer centers, hematology and blood transfusion centers, and nuclear medicine departments; oncology, hematology, and nuclear medicine departments in hospitals or specialized hospitals) and must be prescribed by doctors licensed in oncology or hematology;

b) In cases where they are used for non-cancer treatments:

The health insurance fund shall pay according to the Ministry of Health’s or hospital’s diagnostic and treatment guidelines. If there are no such guidelines, a consultation with an oncologist is required. If there are no guidelines and no oncologist available, a consultation under the leadership of the hospital management must be conducted before prescribing (excluding drugs that do not require consultation with the oncology department as noted in column 9).

8. Medical examination and treatment facilities that can perform higher-level technical services according to the specialized technical tiering shall use drugs according to the list defined for the higher level, consistent with the approved technical services. These facilities shall submit the drug list to the social insurance organization for payment purposes.

9. Drugs self-manufactured by medical examination and treatment facilities in accordance with regulations shall be reimbursed by the health insurance fund when used at these facilities. The drug price for reimbursement shall be established based on the production cost set by the hospital director after agreement with the social insurance organization and bearing legal responsibility.

Article 6. Implementation Organization

1. The Ministry of Health shall be responsible for:

a) Directing, guiding, inspecting, auditing the construction of the drug list,

bidding for drug procurement, managing, using, and paying for drug costs at medical examination and treatment facilities;

b) Take the lead and cooperate with relevant agencies to resolve issues arising during implementation;

c) Taking the lead and coordinating with relevant agencies to update, adjust, amend, and supplement the drug list issued together with this Circular every two years to meet treatment needs and be consistent with the health insurance fund's payment capacity.

2. Vietnam Social Security shall be responsible for:

a) Implement, direct social insurance agencies in provinces and centrally governed cities to cooperate with Health Departments and healthcare facilities in organizing the implementation and payment of drug costs in accordance with the provisions of this Circular and other relevant legal regulations.

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

3. Departments of Health of provinces and centrally-administered cities shall be responsible for:

a) Implement, direct, guide, inspect, and supervise the construction of drug lists, procurement bidding for drugs, management, use, and payment of drug costs at healthcare facilities within their authority.

b) Guide the construction and approval of drug lists for use at clinics without doctors and commune health stations, urban district health stations, and town health stations under their jurisdiction in accordance with regulations.

4. Healthcare facilities shall be responsible for:

a) Construct a list of drugs for use at the unit, including those drugs used to perform higher-level technical services according to the specialization tiering system, and drugs self-manufactured by healthcare facilities.

b) Supply fully, promptly, and in compliance with regulations, meeting the treatment needs of insured patients according to the constructed drug list, ensuring that patients do not have to purchase drugs themselves. Healthcare facilities submit the results of drug procurement bidding and specific finished drug lists used at the facility, which include purchased drugs, drugs used to perform higher-level technical services according to the specialization tiering system, and self-manufactured drugs, to the social insurance organization for payment purposes, following the model provided in Appendix 01 issued together with this Circular.

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

d) Adhere strictly to current regulations on drug management and use, and comply fully with legal regulations on safety and radiation control in managing, supplying, and using radioactive drugs and labeled compounds included in the drug list.

đ) In cases where it is necessary to change or supplement drugs in the drug list for use at the unit, healthcare facilities construct a revised and supplemented drug list, send it to the social insurance organization for payment purposes.

e) In cases where it is necessary to propose modifications, removals, or additions of new drugs to the drug list specified in this Circular to suit actual conditions and meet patient treatment requirements, healthcare facilities submit a request letter according to the model provided in Appendix 02 issued together with this Circular to the Ministry of Health (Health Insurance Department) or provincial Health Departments for consolidation and submission to the Ministry of Health.

Article 7. Transitional Provisions and Cross-References

1. In cases where patients with health insurance cards enter hospitals before the effective date of this Circular but are still undergoing treatment at healthcare facilities, they shall be handled in accordance with Circular No. 31/2011/TT-BYT dated July 11, 2011, and Circular No. 10/2012/TT-BYT dated June 8, 2012, amending and supplementing certain articles of Circular No. 31/2011/TT-BYT dated July 11, 2011, until the patient is discharged from the hospital.

2. For drugs listed in the accompanying list of Circular No. 31/2011/TT-BYT dated July 11, 2011, and Circular No. 10/2012/TT-BYT dated June 8, 2012, amending and supplementing certain articles of Circular No. 31/2011/TT-BYT dated July 11, 2011, but not included in the drug list covered by the health insurance fund in this Circular, the health insurance fund will continue to pay until the contracted amount of such drugs has been exhausted based on the procurement bidding results and contracts signed between healthcare facilities and suppliers prior to the effective date of this Circular.

3. For drugs listed in the accompanying list of Circular No. 31/2011/TT-BYT dated July 11, 2011, but with payment conditions and ratios stipulated in this Circular, the health insurance fund will pay according to the conditions and ratios stipulated in this Circular starting from January 1, 2015 (except for the case stipulated in Clause 1 of this Article).

Article 8. Effective Date

1. This Circular takes effect from January 1, 2015.

2. Circular No. 31/2011/TT-BYT dated July 11, 2011, promulgating and guiding the list of essential drugs used at healthcare facilities covered by the health insurance fund, and Circular No. 10/2012/TT-BYT dated June 8, 2012, amending and supplementing certain articles of Circular No. 31/2011/TT-BYT dated July 11, 2011, cease to be effective from the date this Circular takes effect.

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./.