Circular No. 31/2011/TT-BYT Issuing and guiding the implementation of the List of Essential Medicines for use at medical examination and treatment facilities covered by health insurance funds

CIRCULAR

Issuing and guiding the implementation of the List of Main Medicines for Use at Medical Examination and Treatment Facilities Reimbursed by the Health Insurance Fund

medical examination and treatment covered by the health insurance fund

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Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Pursuant to the Medicine Law dated June 14, 2005; Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing and guiding the implementation of certain provisions of the Medicine Law;

Based on the Health Insurance Law dated November 14, 2008; Decree No. 62/2009/NĐ-CP dated July 27, 2009 of the Government detailing and guiding the implementation of certain provisions of the Health Insurance Law;

Pursuant to the Health Insurance Law dated November 14, 2008; Government Decree No. 62/2009/NĐ-CP dated July 27, 2009 detailing and guiding the implementation of certain provisions of the Health Insurance Law;

Based on Circular Joint No. 09/2009/TTLT-BYT-BTC dated August 14, 2009 of the Ministry of Health and the Ministry of Finance guiding the implementation of health insurance;

The Ministry of Health issues and guides the implementation of the List of Main Medicines for Use at Medical Examination and Treatment Facilities Reimbursed by the Health Insurance Fund (hereinafter referred to as the medicine list) as follows:

Article 1. Issuing the medicine list

Attached to this Circular is the "List of Main Medicines for Use at Medical Examination and Treatment Facilities Reimbursed by the Health Insurance Fund" including:

1. List of modern medicines.

2. List of radioactive substances and labeled compounds.

Article 2. Structure of the medicine list

1. The list of new drugs:

a) The medicine list includes 900 medicines or active ingredients, arranged according to the ATC code (anatomical, therapeutic, chemical); recorded according to the International Nonproprietary Name and the regulations of the National Pharmacopoeia of Vietnam. For active ingredients with multiple ATC codes or different indications will be arranged into the most suitable group to minimize overlap.

b) The medicine list has 8 columns as follows:

- Column 1 records the serial number: numbered according to the name of the medicine or active ingredient;

- Column 2 records the serial number of the medicine or active ingredient in the list;

- Column 3 records the name of the medicine, the name of the active ingredient;

- Column 4 records the route of administration, form of administration;

- Column 5 specifies usage for special class hospitals and Class I hospitals;

- Column 6 specifies usage for Class II hospitals;

- Column 7 specifies usage for Class III and Class IV hospitals;

- Column 8 specifies usage for multi-specialty clinics and other healthcare facilities.

2. The list of radioactive substances and labeled compounds includes 57 active ingredients, recorded according to the International Nonproprietary Name, arranged alphabetically from A, B, C..., and has 5 columns as follows:

- Column 1 records the serial number;

- Column 2 records the name of the radioactive substance and labeled compound;

- Column 3 records the route of administration;

- Column 4 records the form of administration;

- Column 5 records the unit.

Article 3. Guidance on using the medicine list

1. Modern medicines

a) Used according to hospital classification regulations, specialty medicines are used according to management levels and medical practice;

b) Medicines marked with (*) are reserve medicines, restricted use, only used when other medicines in the treatment group are ineffective and must be consulted (except in emergency cases);

c) Medicines classified in this group can be used to treat diseases covered by the Health Insurance Fund if there is a prescription registered in the drug registration dossier that has been approved;

d) Medicines classified in the cancer treatment and immunomodulation groups:

- For medicines with only cancer treatment indications, including those outside the list defined by the Ministry of Health: can only be used at medical examination and treatment facilities with cancer treatment functions and must be prescribed by doctors trained and instructed in oncology;

- For medicines with indications for treating other diseases not being cancer used at hospitals or clinical departments other than the Oncology Department according to the hospital's treatment protocol but must consult with an oncologist to ensure safety and treatment effectiveness.

e) Specific medicines for leprosy, mental illness, epilepsy included in the medicine list issued by this Circular but provided through programs or projects shall be used according to the guidance of such programs or projects.

2. Radioactive substances and labeled compounds in the list must be strictly controlled, therefore supply, use, and management must comply with the regulations and rules on pharmacy and fully comply with all legal provisions on safety and radiation control.

Article 4. Construction of the List of Medicines for Use in Medical Examination and Treatment Facilities

1. Based on the provisions of Articles 2 and 3 of this Circular; based on technical tiering, disease models, and hospital budgets, the Director of the hospital shall direct the Medicine and Treatment Council to construct the List of medicines for use at the facility and develop plans to organize medicine supply to meet treatment needs in accordance with legal regulations on bidding for medicine supply. The Director of the Department of Health shall direct the construction and specify the list of medicines for use at commune health stations.

2. The selection of finished medicines shall follow the principle of prioritizing generic medicines, single-component medicines, domestically produced medicines, and medicines from pharmaceutical enterprises that meet Good Manufacturing Practice (GMP) standards.

3. Medical examination and treatment facilities are responsible for ensuring adequate and timely medicine supply, without allowing patients to purchase their own medicines, including cancer treatments and anti-rejection drugs outside the list but covered by the Health Insurance Fund according to regulations.

Article 5. Payment of Medicine Costs for Patients

1. For the list of new medicines:

a) The name of the medicine listed under a chemical form will be reimbursed by the Health Insurance Fund for other chemical forms of the active ingredient if they have the same therapeutic effect;

b) Medicines will be reimbursed if they comply with the route and form of administration specified in the list. Medicines with routes such as sublingual, chewable, or placed under the tongue will be reimbursed as oral medications; medicines with routes such as topical application, massage, or patches will be reimbursed as external medications; medicines with routes such as intramuscular, subcutaneous, intradermal, intravenous, infusion, intra-articular, or intra-cavity injections will be reimbursed as injectable medications.

c) Medicines containing multiple active ingredients not specified in the list will be reimbursed by the Health Insurance Fund if all individual components are included in the list and comply with the route of administration and hospital classification level (this does not apply to groups of medicines that are mixtures of multiple vitamins);

d) In cases where hospitals can perform services of higher-tier hospitals according to approved specialized technical tiers, they may use medicines prescribed for those higher-tier hospitals.

2. Specialized medicines compounded by hospitals must ensure quality as stipulated. The price of these medicines, reimbursable by the Health Insurance Fund, is based on the product cost set by the hospital director and the hospital is responsible for it under the law.

3. For non-public medical examination and treatment facilities, based on the list of approved technical services, they shall establish a list of medicines and coordinate with the Social Insurance Authority to reimburse medicine costs for insured patients according to regulations.

4. Medicine costs already included in the service technique cost (such as anesthesia, sedation, surgical fluids, or contrast agents used in imaging diagnostics) shall not be reimbursed additionally. Medicines in group XV-Antiseptics and Disinfectants are reimbursed within the service technique cost and bed day cost, and cannot be separated for separate reimbursement.

5. In cases where, according to professional instructions, patients only use part of the quantity of medicine in the smallest unit package (for example, pediatric or oncology-specific medicines) and the remaining quantity cannot be used (for example, due to lack of patients, insufficient dosage, or expiration), the Health Insurance Fund will reimburse the entire smallest unit package.

6. The Health Insurance Fund will only reimburse certain medicines for specific treatment indications as follows:

a) Interferon and peginterferon for treating hepatitis C according to the correct regimen.

b) Rituximab for treating non-Hodgkin's lymphoma B-cell type with positive CD20.

c) Sorafenib for treating advanced renal cell carcinoma and hepatocellular carcinoma.

d) Cerebrolysin and citicoline for acute cerebrovascular accidents and traumatic brain injury.

đ) Nimodipine for subarachnoid hemorrhage caused by cerebral aneurysm or trauma.

Article 6. Procedures and formalities for proposing to supplement, amend, or adjust the list of medicines

1. Annually, based on treatment needs, medical examination and treatment facilities shall propose to supplement, amend, or adjust the List of Medicines to be consistent with actual conditions according to the following objectives and principles:

a) Objectives:

- Ensuring safe, rational, and effective medicine use;

- Meeting patients' treatment needs;

- Ensuring patients' rights to healthcare medicines under health insurance;

- Being appropriate to patients' economic capacity and the health insurance fund's payment capacity.

b) Principles:

- Proposing medicines for inclusion in the List of Medicines based on the essential medicines list of Vietnam and the World Health Organization;

- Being effective in treatment;

- Not proposing medicines that are recommended not to be used by the World Health Organization, the Ministry of Health, or outdated medicines with many side effects;

- Proposed supplementary, amended, or adjusted medicines must be suggested by the Hospital Medicine and Treatment Council.

2. Medical examination and treatment facilities shall submit a request letter (in accordance with the attached Appendix) to the Ministry of Health (Department of Medical Examination and Treatment) or the Department of Health of centrally governed cities and provinces, and sectoral health departments for consideration or proposal to amend, supplement, or adjust.

Article 7. Responsibility for Implementation

1. The List of Medicines issued together with this Circular serves as a basis for medical examination and treatment facilities to select medicines, ensuring treatment needs and reimbursement for patients' medicine costs.

2. Social Insurance agencies and medical examination and treatment facilities are responsible for reimbursing medicine costs for insured patients in accordance with the provisions of this Circular.

Article 8. Effective Date

This Circular takes effect from August 25, 2011. It abolishes the List of New Medicines, the List of Radioactive Medicines and Marked Compounds, and the Guidelines for Using the Mainly Used Medicines List at Medical Examination and Treatment Facilities issued together with Decision No. 05/2008/QD-BYT dated February 1, 2008 of the Minister of Health on issuing the Mainly Used Medicines List at Medical Examination and Treatment Facilities. It also abolishes Circular No. 02/2010/TT-BYT dated January 15, 2010 of the Minister of Health on issuing the Supplementary Medicines List for Children Under Six Years Old within the Scope of Reimbursement by the Health Insurance Fund.

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